Publications by authors named "Robert P Schwartz"

181 Publications

Opioid treatment program and community pharmacy collaboration for methadone maintenance treatment: Results from a feasibility clinical trial.

Addiction 2021 Jul 19. Epub 2021 Jul 19.

Friends Research Institute, Inc., Baltimore, MD, USA.

Background And Aims: Pharmacy administration and dispensing of methadone for methadone maintenance treatment (MMT) can expand treatment access for opioid use disorder (OUD). This study investigated the feasibility and acceptability of a novel model permitting an opioid treatment program (OTP) physician to prescribe methadone for OUD treatment through collaboration with a partnered pharmacy.

Design: Nonrandomized, single-arm, open-label feasibility trial.

Setting: One OTP and one community pharmacy in the US.

Participants: One OTP physician, two pharmacists, and 20 MMT patients receiving between 6 and 13 take-home methadone doses at 5-160 mg/day.

Intervention: Patients' methadone administration and dispensing of take-home doses was transferred from the OTP to the pharmacy for 3 months.

Measurements: Primary outcome was medication adherence. Secondary outcomes were recruitment, treatment retention, substance use, counseling attendance at the OTP, pharmacist prescription drug monitoring program (PDMP) use, safety, and satisfaction.

Findings: Of 29 patients eligible at prescreen, 20 patients (69%) enrolled into the study. Recruitment occurred from 8/6/2020 to 10/7/2020. Treatment retention rate at Month 3 was 80% (16/20). Two participants returned early to the OTP because of a work/schedule change, one due to pregnancy, and one following a non-study related hospitalization. Medication adherence among 16 patients who were retained was 100%. Intervention fidelity was 100%. All participants attended random call-back visits. None showed evidence of tampering/diversion of methadone. Pharmacists checked the PDMP at all visits. All participants attended psychosocial counseling as planned. There were no positive urine screens for illicit opioid use and no study-related adverse events. All participants endorsed "pharmacy is the right location for receiving methadone for MMT," 88% endorsed "convenient or very convenient to receive methadone at the pharmacy, and 88% were satisfied or very satisfied with the quality of treatment offered.

Conclusions: This feasibility trial has found pharmacy administration and dispensing of physician-prescribed methadone for methadone maintenance treatment to be feasible and acceptable.
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http://dx.doi.org/10.1111/add.15641DOI Listing
July 2021

Addiction Medicine Practice-Based Research Network (AMNet): Assessment Tools and Quality Measures.

Subst Abuse Rehabil 2021 25;12:27-39. Epub 2021 Jun 25.

Social Research Center, Friends Research Institute, Baltimore, MD, USA.

Introduction: The need for innovative approaches to address the opioid epidemic in the United States is widely recognized. Many challenges exist to addressing this epidemic, including the obstacles outpatient substance use treatment practices face in implementing measurement-based care (MBC), quality measurement systems, and evidence-based treatments. Also, there are insufficient opportunities for clinicians in these settings to participate in research, resulting in diminished translation of research findings into community-based practice. To address these challenges, the Addiction Medicine Practice-Based Research Network (AMNet) was developed to facilitate the uptake of MBC in outpatient practices via implementation of patient-reported assessments and quality of care performance measures to improve patient outcomes. This network will offer clinicians in outpatient settings (not incuding opioid treatment programs [OTPs]) the opportunity to participate in future substance use disorder treatment research studies.

Methods: A key step in the development of AMNet was the selection of substance use-specific assessment tools and quality of care performance measures for incorporation into the American Psychiatric Association's mental health patient registry, PsychPRO. A scoping review and multi-step consensus-based process were used to identify, review and select candidate assessment tools and quality of care performance measures for opioid use disorders (OUD) and substance use disorders (SUD).

Results: Following a consensus-based methodology, 12 standardized assessment tools and 3 quality of care performance measures for OUD and SUD were selected to help facilitate the implementation of MBC and quality improvement for AMNet participants. These tools were further categorized as core and optional.

Conclusion: By offering a collection of carefully vetted assessment tools and quality measures through PsychPRO, AMNet will help participating clinicians with the systematic uptake of MBC and delivery of evidence-based treatment for patients with SUD. Also, AMNet will act as a centralized repository of data collected from patients and clinicians in non-OTP outpatient addiction medicine practices and serve as a platform for opioid treatment research.
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http://dx.doi.org/10.2147/SAR.S305972DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240849PMC
June 2021

Organizational Acceptability of Implementing SBIRT for Adolescents in Primary Care.

Subst Use Misuse 2021 1;56(10):1536-1542. Epub 2021 Jul 1.

Friends Research Institute, Baltimore, MD, USA.

Introduction: Adolescent illicit drug, tobacco, and alcohol use can result in sudden and long-term negative health consequences. Primary care environments present the optimal opportunity for screening and brief interventions that target prevention and curtailing use. Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a service delivery method that could potentially be well-integrated into primary care settings and used to serve a high volume of adolescents. : This qualitative analysis of clinic staff interviews ( = 20), collected during a large cluster-randomized trial to implement two models of adolescent SBIRT, examined barriers and facilitating factors to overall acceptability of SBIRT. This study was conducted in a large, urban Federally Qualified Health Center (FQHC) at 7 sites throughout Baltimore City, Maryland, USA. Participants from each clinic included a range of various roles and responsibilities including: medical assistants ( = 3), nurses ( = 3), primary care providers ( = 4), behavioral health counselors ( = 4), and administrators ( = 6). : Results indicate both barriers and facilitating factors for acceptability of SBIRT in terms of (1) universal screening, (2) provider time demands, (3) behavioral health collaboration, and (4) behavioral health caseloads. : Universal screening was acceptable to participants across organizational roles, but brief interventions and referrals to treatment were found substantially less acceptable.
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http://dx.doi.org/10.1080/10826084.2021.1942054DOI Listing
July 2021

Views of barriers and facilitators to continuing methadone treatment upon release from jail among people receiving patient navigation services.

J Subst Abuse Treat 2021 Aug 4;127:108351. Epub 2021 Mar 4.

Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address:

Background: Patient navigation has potential for assisting patients who initiate methadone during pretrial detention to enter and remain in treatment following release, but we know little about participants' experiences with this service.

Methods: This study drew a purposive sample of male and female participants (N = 17) from participants enrolled in a randomized trial of initiating methadone with vs. without patient navigation while in the Baltimore City Detention Center. The study interviewed participants in the community at 1 and 3 months following release and asked them about their experiences of reentry, methadone treatment continuation, drug use, and interactions with the patient navigator. The study recorded, transcribed, coded using Atlas.ti, and analyzed thematically the interviews.

Results: Participants reported encountering four key challenges in the community: getting to treatment following release, assembling basic supports, managing criminal justice system demands, and staying in treatment. Participants' experiences of the patient navigator's support to address these challenges fell into six thematic groups: showing nonjudgmental caring and persistence, advocating within programs, brokering resources, managing interactions with the criminal justice system, balancing encouragement and self-determination, and offering genuine and familial-type support.

Conclusion: Nearly all participants appreciated the navigator's support and deemed it helpful. The previously reported randomized trial found that participants assigned to initiate methadone treatment with navigation had higher rates of receiving their first "guest" methadone dose in the community but did not have significantly different rates of treatment enrollment or of illicit opioid use compared to those assigned to begin methadone treatment without navigation. Treatment programs should work to improve retention and postrelease outcomes among this population.
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http://dx.doi.org/10.1016/j.jsat.2021.108351DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8217714PMC
August 2021

Drug and sexual HIV-risk behaviors among adolescents and young adults with opioid use disorder.

J Subst Abuse Treat 2021 May 19;130:108477. Epub 2021 May 19.

Friends Research Institute, Inc., 1040 Park Avenue, Suite 103, Baltimore, MD 21201, United States of America.

Opioid use disorder (OUD) among adolescents and young adults (youth) is associated with drug use and sexual HIV-related risk behaviors and opioid overdose. This mixed methods analysis assesses risk behaviors among a sample of 15-21-year-olds (N = 288) who were being treated for OUD in a residential drug treatment program in Baltimore, Maryland. Participants were enrolled in a parent study in which they received either extended-release naltrexone (XR-NTX) or Treatment as Usual (TAU), consisting of outpatient counseling with or without buprenorphine, prior to discharge. At baseline, participants were administered the HIV-Risk Assessment Battery (RAB), and clinical intake records were reviewed to determine participants' history of sexual, physical, or other abuse, as well as parental and partner substance use. A sub-sample of study participants completed semi-structured qualitative interviews (N = 35) at baseline, three-, and six-month follow-up periods. This analysis identified gender (e.g., female IRR = 1.63, CI 1.10-2.42, p = .014), the experience of dependence (e.g., previous detoxification IRR = 1.08, CI 1.01-1.15, p = .033) and withdrawal (e.g., severe withdrawal symptoms IRR = 1.41, CI 1.08-1.84, p = .012), and the role of relationships (e.g., using with partner IRR = 2.45, CI 1.15-5.22, p = .021) as influencing high-risk substance use behaviors. Similarly, high-risk sex was influenced by gender (e.g., female IRR = 1.43, CI 1.28-1.59, p < .001), and the role of relationships (e.g., using with partner IRR = 0.78, CI 0.62-0.98, p = .036). These are key targets for future prevention, treatment, and intervention.
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http://dx.doi.org/10.1016/j.jsat.2021.108477DOI Listing
May 2021

Extended-release naltrexone for youth with opioid use disorder.

J Subst Abuse Treat 2021 Apr 15;130:108407. Epub 2021 Apr 15.

Friends Research Institute, 1040 Park Avenue, Suite, 103 Baltimore, MD, USA. Electronic address:

Background: Few published research studies have examined the effectiveness of extended-release naltrexone (XR-NTX) for the treatment of opioid use disorder (OUD) among adolescents and young adults.

Methods: This two-group randomized controlled trial recruited 288 youth, ages 15-21, with moderate/severe OUD from a residential addiction treatment program in Baltimore, Maryland. The study randomized the youth within the first week of treatment entry to receive either XR-NTX or treatment-as-usual (TAU; either buprenorphine maintenance treatment or treatment without OUD medication following medically managed withdrawal) prior to discharge, with continued treatment in the community for 6 months. However, due to various reasons spanning patients' and caregivers' preferences and constraints, considerable participant nonadherence to randomized condition occurred (i.e., only 30% of the participants randomized to XR-NTX received an initial injection, while 27% of participants randomized to TAU received an XR-NTX injection at treatment discharge, instead of their assigned treatment). The study used generalized linear mixed modeling (GLiMM) to examine self-reported 90-day opioid, cocaine, marijuana, and alcohol use as well as DSM-5 OUD criteria on "intention-to-treat" (as randomized), "as-received" (XR-NTX vs. not XR-NTX), and "as-medicated" (XR-NTX vs. buprenorphine vs. no medication) bases.

Results: The condition x time interactions in the intention-to-treat analyses failed to reach significance for past-90-day self-reported use of illicit opioids, cocaine, marijuana, or alcohol, or in meeting DSM-5 OUD criteria at 3 or 6 months [all ps > 0.05]. However, these findings are of limited interpretive value due to participant nonadherence to their randomized condition. When the study analyzed results by the treatment received at discharge, the "as-received" group x time interaction for illicit opioid use was significant [p = .003], with the XR-NTX group reporting less opioid use in the past 90 days at 3 and 6 months. Participants who received their first XR-NTX dose at inpatient discharge (n = 82) received, on average, 1.3 subsequent injections in the community over the 6-month study follow-up period. Only 2 of the 82 study participants received XR-NTX continuously through the 6-month postdischarge follow-up period. Twelve serious adverse events (SAEs) occurred during the study, but the study determined that only 1 was possibly study related (hepatitis C/elevated liver function test results).

Conclusion: None of the condition x time interactions in the intention-to-treat analyses reached significance. Participants' nonadherence may have contributed to the failure to reject the null hypothesis. Irrespective of randomized condition, participants who received XR-NTX for OUD demonstrated low retention in treatment, receiving an average of only 1.3 subsequent injections, yet reported less opioid use at follow-up than participants who did not received XR-NTX. Treatment programs should consider XR-NTX as a treatment option for youth motivated to receive it. Future research should focus on building developmentally informed strategies to improve uptake of and adherence to relapse prevention medication in this population.
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http://dx.doi.org/10.1016/j.jsat.2021.108407DOI Listing
April 2021

Extended-release naltrexone for youth with opioid use disorder.

J Subst Abuse Treat 2021 Apr 15;130:108407. Epub 2021 Apr 15.

Friends Research Institute, 1040 Park Avenue, Suite, 103 Baltimore, MD, USA. Electronic address:

Background: Few published research studies have examined the effectiveness of extended-release naltrexone (XR-NTX) for the treatment of opioid use disorder (OUD) among adolescents and young adults.

Methods: This two-group randomized controlled trial recruited 288 youth, ages 15-21, with moderate/severe OUD from a residential addiction treatment program in Baltimore, Maryland. The study randomized the youth within the first week of treatment entry to receive either XR-NTX or treatment-as-usual (TAU; either buprenorphine maintenance treatment or treatment without OUD medication following medically managed withdrawal) prior to discharge, with continued treatment in the community for 6 months. However, due to various reasons spanning patients' and caregivers' preferences and constraints, considerable participant nonadherence to randomized condition occurred (i.e., only 30% of the participants randomized to XR-NTX received an initial injection, while 27% of participants randomized to TAU received an XR-NTX injection at treatment discharge, instead of their assigned treatment). The study used generalized linear mixed modeling (GLiMM) to examine self-reported 90-day opioid, cocaine, marijuana, and alcohol use as well as DSM-5 OUD criteria on "intention-to-treat" (as randomized), "as-received" (XR-NTX vs. not XR-NTX), and "as-medicated" (XR-NTX vs. buprenorphine vs. no medication) bases.

Results: The condition x time interactions in the intention-to-treat analyses failed to reach significance for past-90-day self-reported use of illicit opioids, cocaine, marijuana, or alcohol, or in meeting DSM-5 OUD criteria at 3 or 6 months [all ps > 0.05]. However, these findings are of limited interpretive value due to participant nonadherence to their randomized condition. When the study analyzed results by the treatment received at discharge, the "as-received" group x time interaction for illicit opioid use was significant [p = .003], with the XR-NTX group reporting less opioid use in the past 90 days at 3 and 6 months. Participants who received their first XR-NTX dose at inpatient discharge (n = 82) received, on average, 1.3 subsequent injections in the community over the 6-month study follow-up period. Only 2 of the 82 study participants received XR-NTX continuously through the 6-month postdischarge follow-up period. Twelve serious adverse events (SAEs) occurred during the study, but the study determined that only 1 was possibly study related (hepatitis C/elevated liver function test results).

Conclusion: None of the condition x time interactions in the intention-to-treat analyses reached significance. Participants' nonadherence may have contributed to the failure to reject the null hypothesis. Irrespective of randomized condition, participants who received XR-NTX for OUD demonstrated low retention in treatment, receiving an average of only 1.3 subsequent injections, yet reported less opioid use at follow-up than participants who did not received XR-NTX. Treatment programs should consider XR-NTX as a treatment option for youth motivated to receive it. Future research should focus on building developmentally informed strategies to improve uptake of and adherence to relapse prevention medication in this population.
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http://dx.doi.org/10.1016/j.jsat.2021.108407DOI Listing
April 2021

Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults (EXIT-CJS).

J Subst Abuse Treat 2021 Apr 8:108389. Epub 2021 Apr 8.

NYU Grossman SOM, United States of America. Electronic address:

The EXIT-CJS (N = 1005) multisite open-label randomized controlled trial will compare retention and effectiveness of extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) to treat opioid use disorder (OUD) among criminal justice system (CJS)-involved adults in six U.S. locales (New Jersey, New York City, Delaware, Oregon, Connecticut, and New Hampshire). With a pragmatic, noninferiority design, this study hypothesizes that XR-B (n = 335) will be noninferior to XR-NTX (n = 335) in retention-in-study-medication treatment (the primary outcome), self-reported opioid use, opioid-positive urine samples, opioid overdose events, and CJS recidivism. In addition, persons with OUD not eligible or interested in the RCT will be recruited into an enhanced treatment as usual arm (n = 335) to examine usual care outcomes in a quasi-experimental observational cohort.
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http://dx.doi.org/10.1016/j.jsat.2021.108389DOI Listing
April 2021

Addiction Medicine Practice-Based Research Network (AMNet): Building Partnerships.

Psychiatr Serv 2021 Jul 15;72(7):845-847. Epub 2021 Apr 15.

Friends Research Institute, Baltimore (Schwartz, Ibrahim, Vocci); American Psychiatric Association, Washington, D.C. (Gibson, Doty, Patel, Clarke); American Society of Addiction Medicine, Rockville, MD (Pagano); National Institute on Drug Abuse (NIDA), Rockville, MD (Goldstein). Debra A. Pinals, M.D., Enrico G. Castillo, M.D., M.S.H.P.M., and Ayorkor Gaba, Psy.D., are editors of this column.

This column describes the collaboration among the American Psychiatric Association (APA), American Society of Addiction Medicine, Friends Research Institute, and the National Institute on Drug Abuse to create the Addiction Medicine Practice-Based Research Network (AMNet). The collaboration, which aims to address the opioid overdose epidemic in the United States, leverages the APA's clinical data registry (PsychPRO) and is recruiting office-based addiction medicine and addiction psychiatry practices for AMNet. AMNet aims to address knowledge gaps regarding patient care in such practices, facilitate performance improvement efforts, and serve as a research platform.
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http://dx.doi.org/10.1176/appi.ps.202000390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8249311PMC
July 2021

De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial.

JMIR Res Protoc 2021 Apr 12;10(4):e24342. Epub 2021 Apr 12.

Friends Research Institute Inc, Baltimore, MD, United States.

Background: Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that, in most cases, the combination of ibuprofen and acetaminophen is an effective alternative to commonly prescribed opioid analgesics for the management of postextraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions.

Objective: We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective nonopioid analgesics following dental extractions.

Methods: Using a prospective, 3-arm, cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients. The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to postimplementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for nonopioid analgesics, patients' perceptions of shared decision making, and patients' pain experiences following the extraction.

Results: The HealthPartners Institutional Review Board approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested, and the protocol has been approved by the National Institute of Dental and Craniofacial Research. The intervention was implemented in February 2020, with 51 dentists who were randomized to 1 of the 3 arms.

Conclusions: If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing.

Trial Registration: ClinicalTrials.gov NCT03584789, https://clinicaltrials.gov/ct2/show/NCT03584789.

International Registered Report Identifier (irrid): DERR1-10.2196/24342.
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http://dx.doi.org/10.2196/24342DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076983PMC
April 2021

Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder : A Randomized Trial.

Ann Intern Med 2021 Jul 6;174(7):899-909. Epub 2021 Apr 6.

Friends Research Institute, Baltimore, Maryland (J.G., C.D.N., S.G.M., R.P.S.).

Background: Hospitalized patients with comorbid substance use disorders (SUDs) are at high risk for poor outcomes, including readmission and emergency department (ED) use.

Objective: To determine whether patient navigation services reduce hospital readmissions.

Design: Randomized controlled trial comparing Navigation Services to Avoid Rehospitalization (NavSTAR) versus treatment as usual (TAU). (ClinicalTrials.gov: NCT02599818).

Setting: Urban academic hospital in Baltimore, Maryland, with an SUD consultation service.

Participants: 400 hospitalized adults with comorbid SUD (opioid, cocaine, or alcohol).

Intervention: NavSTAR used proactive case management, advocacy, service linkage, and motivational support to resolve internal and external barriers to care and address SUD, medical, and basic needs for 3 months after discharge.

Measurements: Data on inpatient readmissions (primary outcome) and ED visits for 12 months were obtained for all participants via the regional health information exchange. Entry into SUD treatment, substance use, and related outcomes were assessed at 3-, 6-, and 12-month follow-up.

Results: Participants had high levels of acute care use: 69% had an inpatient readmission and 79% visited the ED over the 12-month observation period. Event rates per 1000 person-days were 6.05 (NavSTAR) versus 8.13 (TAU) for inpatient admissions (hazard ratio, 0.74 [95% CI, 0.58 to 0.96]; 0.020) and 17.66 (NavSTAR) versus 27.85 (TAU) for ED visits (hazard ratio, 0.66 [CI, 0.49 to 0.89]; 0.006). Participants in the NavSTAR group were less likely to have an inpatient readmission within 30 days than those receiving TAU (15.5% vs. 30.0%; 0.001) and were more likely to enter community SUD treatment after discharge ( 0.014; treatment entry within 3 months, 50.3% NavSTAR vs. 35.3% TAU).

Limitation: Single-site trial, which limits generalizability.

Conclusion: Patient navigation reduced inpatient readmissions and ED visits in this clinically challenging sample of hospitalized patients with comorbid SUDs.

Primary Funding Source: National Institute on Drug Abuse.
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http://dx.doi.org/10.7326/M20-5475DOI Listing
July 2021

Until there's nothing left: Caregiver resource provision to youth with opioid use disorders.

Subst Abus 2021 Mar 24:1-8. Epub 2021 Mar 24.

Friends Research Institute, Inc, Baltimore, Maryland, USA.

Despite the considerable literature associating certain characteristics of caregivers and family structures with risks of adolescent/young adult (youth) substance use, there has been little study of the role of caregivers in opioid use disorder (OUD) treatment outcomes. This qualitative study sought to understand and contextualize the factors that influenced the resources caregivers provided their youth after residential treatment. In order to improve understandings of the role caregivers play both during and after residential OUD treatment, 31 caregivers of youth who were in a residential substance use disorder treatment center were interviewed at baseline, three-months, and six-months following their youth's discharge. This analysis focused on the provision of caregiver resources and identified three key influences - OUD understandings and expectations, relationships with youth, and the emotional toll on caregivers. This has important implications as residential treatment success rates are relatively low among this population. These findings suggest that engagement of caregivers and families in outpatient care following residential treatment could offer an important opportunity for interventions that promote youth recovery.
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http://dx.doi.org/10.1080/08897077.2021.1901178DOI Listing
March 2021

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment.

Addict Sci Clin Pract 2021 01 31;16(1). Epub 2021 Jan 31.

Kaiser Permanente Northwest, Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.

Background: Most people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.

Methods: PROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization.

Discussion: The PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.
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http://dx.doi.org/10.1186/s13722-021-00218-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7849121PMC
January 2021

Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study.

Trials 2021 Jan 28;22(1):102. Epub 2021 Jan 28.

Addictions Department, Division of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, DeCrespigny Park, Denmark Hill, London, SE5 8AF, UK.

Background: A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.

Methods/design: Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.

Discussion: This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.

Trial Registration: http://www.comet-initiative.org/Studies/Details/1579.
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http://dx.doi.org/10.1186/s13063-021-05051-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841754PMC
January 2021

An alternative analysis of illicit opioid use during treatment in a randomized trial of extended-release naltrexone versus buprenorphine-naloxone: A per-protocol and completers analysis.

Drug Alcohol Depend 2021 02 9;219:108422. Epub 2020 Dec 9.

New York University School of Medicine, 550 1st Avenue, New York, NY, 10016, USA.

Background: The distinct pharmacological properties and clinical uses of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) present challenges in analyzing patient outcomes.

Methods: We conducted a secondary analysis of a multi-site randomized trial comparing XR-NTX with sublingual BUP-NX treatment for opioid use disorder initiated during inpatient detoxification and continued in outpatient treatment. Urine testing data for non-study opioids from the last 22 weeks of the 24-week trial were analyzed in both a per-protocol sample (n = 474 participants who received at least one dose of medication) and a completers sample (n = 211 participants who received all XR-NTX doses or all BUP-NX prescriptions). The present analyses sought to identify differences in the weekly percentages of opioid-positive urine tests between participants treated with the two medications.

Results: The proportion of opioid-positive tests in both conditions was less than 20 % for 21 of the 22 weeks in the per-protocol sample and all 22 weeks in the completers sample. Generalized linear mixed model analyses revealed a significant treatment (XR-NTX vs. BUP-NX) X week (weeks 3-24) interaction in the per-protocol sample but not the completers sample. In the per-protocol analysis, the BUP-NX, compared to XR-NTX, had significantly greater proportions of opioid-positive tests in 14 out of the 22 weeks.

Conclusions: Longitudinal modeling approaches that utilize flexible procedures for handling missing data can offer a different perspective on study findings. Results from the present analyses suggest that XR-NTX appeared to be somewhat more effective than BUP-NX in reducing illicit opioid use in the per-protocol sample.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.108422DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8034542PMC
February 2021

Computer- vs. nurse practitioner-delivered brief intervention for adolescent marijuana, alcohol, and sex risk behaviors in school-based health centers.

Drug Alcohol Depend 2021 01 23;218:108423. Epub 2020 Nov 23.

University of Maryland Baltimore County, Catonsville MD, Dept. of Psychology, 1000 Hilltop Circle, Baltimore, MD 21250, United States.

Background: This study examined approaches to delivering brief interventions (BI) for risky substance use and sexual behaviors in school-based health centers (SBHCs).

Methods: 300 Adolescents (ages 14-18; 54 % female) with risky marijuana and/or alcohol use identified via CRAFFT screening (scores >1) were recruited from two SBHCs and randomized to computer-delivered BI (CBI) or nurse practitioner-delivered BI (NBI). Both BIs included motivational and didactic content targeting marijuana, alcohol, and risky sexual behaviors. Assessments at baseline, 3-month, and 6-month follow-up included past 30-day frequency of marijuana use, alcohol use, binge drinking, unprotected sex, and sex while intoxicated; marijuana and alcohol problems; and health-related quality-of-life (HRQoL). A focused cost-effectiveness analysis was conducted. An historical 'assessment-only' cohort (N=50) formed a supplementary quasi-experimental comparison group.

Results: There were no significant differences between NBI and CBI on any outcomes considered (e.g., days of marijuana use; p=.26). From a cost-effectiveness perspective, CBI was 'dominant' for HRQoL and marijuana use. Participants' satisfaction with BI was significantly higher for NBI than CBI. Compared to the assessment-only cohort, participants who received a BI had lower frequency of marijuana (3-months: Incidence Rate Ratio [IRR] = .74 [.57, .97], p=.03), alcohol (3-months: IRR = .43 [.29, .64], p<.001; 6-months: IRR = .58 [.34, .98], p = .04), alcohol-specific problems (3-months: IRR = .63 [.45, .89], p=.008; 6-months: IRR = .63 [.41, .97], p = .04), and sex while intoxicated (6-months: IRR = .42 [.21, .83], p = .013).

Conclusions: CBI and NBI did not yield different risk behavior outcomes in this randomized trial. Supplementary quasi-experimental comparisons suggested potential superiority over assessment-only. Both NBI and CBI could be useful in SBHCs.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.108423DOI Listing
January 2021

Randomized trial of methadone treatment of arrestees: 24-month post-release outcomes.

Drug Alcohol Depend 2021 01 2;218:108392. Epub 2020 Nov 2.

Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD 21201, USA. Electronic address:

Background: We report on the 24-month post-release outcomes of arrestees with opioid use disorder (OUD) enrolled in a randomized trial comparing three treatment approaches initiated in jail.

Methods: Adults (N = 225) receiving medically supervised withdrawal from opioids in the Baltimore Detention Center within a few days of arrest were randomly assigned to: (1) interim methadone treatment plus patient navigation (IM + PN) started in the Detention Center; (2) IM; or (3) Enhanced Treatment-as-Usual (ETAU) consisting of detoxification with methadone and referral to treatment in the community. Participants in both methadone conditions could transfer to standard methadone treatment following release. Participants were interviewed at baseline, and 1, 3, 6, 12, and 24 months post-release. Urine was drug tested at follow-up and official arrest records were obtained.

Results: On an intention-to-treat basis, there were no significant differences among the three conditions over the 24-month post-release period in terms of opioid- or cocaine-positive urine test results or self-reported opioid or cocaine use, meeting opioid or cocaine use disorder criteria, self-reported criminal behavior, or the number of official arrests. There were 9 fatal overdoses, none occurring during methadone treatment, and 109 hospitalizations unrelated to the study.

Conclusions: Given the high morbidity and mortality found in this population of arrestees and costs to society associated with their health care utilization and continued crime and arrests, research aimed at finding more effective interventions should be continued.

Clinical Trial Registration: ClinicalTrials.gov: NCT02334215.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.108392DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750207PMC
January 2021

Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.

Drug Alcohol Depend 2020 12 16;217:108292. Epub 2020 Sep 16.

Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.

Background: Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.

Methods: We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.

Results: The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.

Conclusions: IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.108292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736121PMC
December 2020

Opioid overdose experiences in a sample of US adolescents and young adults: a thematic analysis.

Addiction 2021 04 31;116(4):865-873. Epub 2020 Aug 31.

Friends Research Institute, Baltimore, USA.

Background And Aims: Opioid overdose deaths among adolescents and young adults have risen sharply in the United States over recent decades. This study aimed to explore the nature of adolescent and young adult perspectives on overdose experiences.

Design: This study involved thematic analysis of interviews undertaken as part of a mixed-methods, randomized trial of extended release naltrexone (XR-NTX) versus treatment-as-usual (TAU) for adolescents and young adults (aged 15-21 years) with opioid use disorder (OUD).

Setting: Participants were recruited during a residential treatment episode at Mountain Manor Treatment Center, in Baltimore, MD, USA.

Participants/cases: As part of the qualitative component of this study, 35 adolescents/young adults completed up to three interviews: at baseline, 3 and 6 months after release from residential opioid use disorder treatment.

Measurements: Semi-structured interviews solicited participant experiences with opioid use disorder treatment; their satisfaction with the medications used to treat opioid use disorder; counseling received; current substance use; issues related to treatment retention; their treatment goals; and their future outlook.

Findings: Four broad themes emerged: (1) adolescents/young adults had difficulty identifying overdoses due to interpreting subjective symptoms and a lack of memory of the event, (2) this sample had difficulty perceiving risk that is misaligned with traditional understandings of overdose intentionality, (3) adolescents/young adults did not interpret personal overdose events as a catalyst for behavior change and (4) this sample experienced a greater impact to behavior change through witnessing an overdose of someone in their social network.

Conclusions: The sample of US adolescents and young adults in treatment for opioid use disorder expressed difficulty identifying whether or not they had experienced an overdose, expressed fluctuating intentionality for those events and did not have clear intentions to change their behavior. Witnessing an overdose appeared to be as salient an experience as going through an overdose oneself.
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http://dx.doi.org/10.1111/add.15216DOI Listing
April 2021

Development and Feasibility of a Spanish Language Version of the Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use (TAPS) Tool.

J Addict Med 2021 Jan-Feb 01;15(1):61-67

School of Social Work, University of Texas at Arlington, TX (KS); Friends Research Institute, Baltimore, MD (JG, SBC, RPS); COG Analytics, Potomac, MD.

Objectives: The Tobacco, Alcohol, Prescription drug, and illicit Substance use (TAPS) Tool is a validated two-stage screening and brief assessment in primary care for unhealthy substance use. We developed a Spanish language version of the TAPS Tool and conducted a small study of its feasibility, acceptability, and preliminary validity.

Methods: Participants were adult primary care patients ages 18 or older with Spanish as their primary language (N = 10 for development/refinement using qualitative congnitive interviewing; N = 100 for the preliminary validation study). The Spanish language TAPS Tool was administered in both interviewer- and selfadministered tablet format (in random order). We examined disclosure of substance use on the TAPS by administration format, and compared it with established measures for identifying substance use and substance use disorders.

Results: The Spanish language TAPS was feasible to use and participants reported high levels of acceptability. The rates of past 12-month substance use were 11% for tobacco, 28% for risky alcohol, 4% for illicit drugs, 1% for nonmedical prescription drugs and substance use disorders rates were 7% for tobacco, 2% for alcohol, and 1% for other substances. The selfadministered TAPS elicited 1, 3, and 1 additional disclosures of tobacco, risky, alcohol, and marijuana use than the interviewer-administered TAPS, respectively. Rates of disclosure on the TAPS were similar to those on established measures for past 12-month and 3-month time frames.

Conclusions: The current study represents a starting point for expanding the availability of the TAPS Tool beyond its original English language version into Spanish. The Spanish language TAPS Tool could expand options for substance use screening in primary care settings with Spanish-dominant/preferred populations.

Trial Registration: The studies were registered with www.clinicaltrials.gov: NCT03879785, March 19, 2019.
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http://dx.doi.org/10.1097/ADM.0000000000000699DOI Listing
June 2021

Leveraging health information exchange for clinical research: Extreme underreporting of hospital service utilization among patients with substance use disorders.

Drug Alcohol Depend 2020 07 27;212:107992. Epub 2020 Apr 27.

Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD 21201, USA.

Background: Substance use disorders are associated with inefficient and fragmented use of healthcare services. The Chesapeake Regional Information System for Our Patients, Inc. (CRISP) is a Health Information Exchange (HIE) linking disparate systems of care in the mid-Atlantic region.

Methods: This article describes applications of HIE for tracking hospital service utilization in substance use disorder clinical and services research, drawing upon data from one of the first studies approved to access the CRISP HIE. Participants were 200 medical/surgical inpatients with comorbid opioid, cocaine, and/or alcohol use disorder (45.5 % female; 56.5 % black; 77.5 % opioid use disorder; 42.0 % homeless). This study compared HIE-identified hospital service utilization with conventional methods of participant self-report during in-person research follow-ups (3-, 6-, and 12-months post-discharge) and electronic health record (EHR) review from the hospital system of the index admission.

Results: This sample exhibited high levels of hospital utilization, which would have been underestimated using conventional methods. Relying exclusively on self-report in the 12-month observation period would have identified only 33.8 % of 429 inpatient hospitalizations and 9.0 % of 1,287 ED visits, due to both loss-to-follow-up and failure to report events. Even combining self-report with single-system EHR review identified only 66.2 % of inpatient hospitalizations and 59.8 % of ED visits.

Conclusions: CRISP HIE data were superior to conventional methods for ascertaining hospital service utilization in this sample of patients exhibiting high-volume and fragmented care. The use of HIE holds implications for improving rigor, safety, and efficiency in research studies.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.107992DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7299087PMC
July 2020

Impact of methadone treatment initiated in jail on subsequent arrest.

J Subst Abuse Treat 2020 06 4;113:108006. Epub 2020 Apr 4.

Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, USA. Electronic address:

Background: There are limited data from randomized trials about the impact of starting methadone treatment in jail on subsequent arrest after release for adults with opioid use disorder (OUD).

Methods: Official arrest records were obtained for 212 participants with OUD who were enrolled in a three-group randomized controlled trial of initiating methadone treatment in jail either with or without patient navigation vs. enhanced treatment-as-usual in Baltimore, Maryland. Participants treated for opioid withdrawal in jail were assigned to: 1) interim methadone (IM) with patient navigation (PN; IM + PN); 2) IM without PN (IM); or 3) enhanced treatment-as-usual (ETAU). Participants in both IM groups were able to continue treatment at a community-based methadone treatment program with counseling upon release, while ETAU participants received overdose information and a city-wide treatment assessment/referral number. Likelihood of arrest, time to first subsequent arrest, and severity of arrest charges in the 12 months following release were examined for: 1) combined IM + PN and IM groups compared to ETAU; and 2) IM + PN compared to IM.

Results: Within 12 months of release from the index incarceration, 50.5% of the sample had been arrested. The majority of arrest charges (71%) were for low-level, nonviolent crimes. On an intention-to-treat basis, there were no significant differences between the combined IM + PN and IM groups vs. ETAU or IM + PN vs. IM in the likelihood of arrest, time to first subsequent arrest, or severity of arrest charges.

Conclusion: Initiating IM with or without PN during pretrial detention did not have a significant effect on subsequent arrest during a 12-month post-release follow-up compared to not starting methadone maintenance during detention, despite the high rate of methadone treatment entry in the community following release. This finding may be attributable to the considerable attrition from treatment in the community or other systematic factors. Additional interventions may be needed to reduce the likelihood of subsequent arrest.
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http://dx.doi.org/10.1016/j.jsat.2020.108006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7659732PMC
June 2020

Documented opioid use disorder and its treatment in primary care patients across six U.S. health systems.

J Subst Abuse Treat 2020 03;112S:41-48

Kaiser Permanente Washington Health Research Institute, United States of America.

Background: The United States is in the middle of an opioid overdose epidemic, and experts are calling for improved detection of opioid use disorders (OUDs) and treatment with buprenorphine or extended release (XR) injectable naltrexone, which can be prescribed in general medical settings. To better understand the magnitude of opportunities for treatment among primary care (PC) patients, we estimated the prevalence of documented OUD and medication treatment of OUD among PC patients.

Methods: This cross-sectional study included patients with ≥2 visits to PC clinics across 6 healthcare delivery systems who were ≥16 years of age during the study period (fiscal years 2014-2016). Diagnoses, prescriptions, and healthcare utilization were ascertained from electronic health records and insurance claims (5 systems that also offer health insurance). Documented OUDs were defined as ≥1 International Classification of Diseases code for OUDs (active or remission), and OUD treatment was defined as ≥1 prescription(s) for buprenorphine formulations indicated for OUD or naltrexone XR, during the 3-year study period. The prevalence of documented OUD and treatment (95% confidence intervals) across health systems were estimated, and characteristics of patients by treatment status were compared. Prevalence of OUD and OUD treatment were adjusted for age, gender, and race/ethnicity. Combined results were also adjusted for site.

Result: Among 1,403,327 eligible PC patients, 54-62% were female and mean age ranged from 46 to 51 years across health systems. The 3-year prevalence of documented OUD ranged from 0.7-1.4% across the health systems. Among patients with documented OUD, the prevalence of medication treatment (primarily buprenorphine) varied across health systems: 3%, 12%, 16%, 20%, 22%, and 36%.

Conclusion: The prevalence of documented OUD and OUD treatment among PC patients varied widely across health systems. The majority of PC patients with OUD did not have evidence of treatment with buprenorphine or naltrexone XR, highlighting opportunities for improved identification and treatment in medical settings. These results can inform initiatives aimed at improving treatment of OUD in PC. Future research should focus on why there is such variation and how much of the variation can be addressed by improving access to medication treatment.
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http://dx.doi.org/10.1016/j.jsat.2020.02.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7107675PMC
March 2020

Comparison of timeline follow-back self-report and oral fluid testing to detect substance use in adult primary care patients.

Drug Alcohol Depend 2020 04 22;209:107939. Epub 2020 Feb 22.

Friends Research Institute, Inc., Baltimore, MD, USA.

Background: Timeline Follow-back (TLFB) interviews using self-report are often used to assess substance use. Oral fluid testing (OFT) offers an objective measure of substance use. There are limited data on the agreement between TLFB and OFT.

Methods: In this secondary analysis from a multisite study in five primary care sites, self-reported TLFB and OFT data collected under confidential conditions were compared to assess concordance (N=1799). OFT samples were analyzed for marijuana, heroin, cocaine, and non-medical use of prescription opioids. Demographic differences in discordance relative to TLFB and OFT concordant results for marijuana, the only substance with an adequate sample size in this analysis, were examined using multinomial logistic regression.

Results: Overall concordance rates between TLFB and OFT were 94.9 % or higher for each substance, driven by large subgroups with no use. Among participants with discordant use, marijuana was the only substance with lower detection on OFT than self-report (27.6 % OFT-positive only vs 32.2 % TLFB-positive only), whereas cocaine (65.6 % vs 8.6 %), prescription opioids (90.4 % vs 6.0 %), and heroin (40.7 % vs 26.0 %) all had higher detection via OFT than TLFB. Participants who reported marijuana use but had a negative OFT were more likely to be younger, Hispanic, and White compared to those with TLFB and OFT concordant positive results.

Conclusions: TLFB and OFT show disparate detection of different substances. Researchers should consider the implications of using either self-report or oral fluid testing in isolation, depending on the substance and collection setting. Triangulating multiple sources of information may improve detection of drug use.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.107939DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360056PMC
April 2020

Adolescent SBIRT implementation: Generalist vs. Specialist models of service delivery in primary care.

J Subst Abuse Treat 2020 04 20;111:67-72. Epub 2020 Jan 20.

University of North Carolina at Wilmington, Wilmington, NC, United States of America.

Background: Drug, alcohol, and tobacco use among adolescents pose significant short- and long-term health consequences and are associated with more severe use as adults. Screening, brief intervention, and referral to treatment in primary care settings has the potential to deliver preventive interventions to a diverse range of adolescents, but optimal implementation of these services needs to be determined. The purpose of this study was to compare implementation of two different SBIRT service delivery models in primary care settings.

Methods: This cluster-randomized trial assigned 7 primary care clinics of a federally qualified health center to implement brief interventions (BI) using a Generalist model (4 sites), in which BIs were delivered by the primary care provider (PCP), or a Specialist model (3 sites), in which BIs were delivered by a behavioral health counselor (BHC) for adolescent patients ages 12-17 years. Implementation was tracked through the clinic's electronic health record, spanning 9639 clinic visits over 20 months. Multilevel logistic regression modeling was used to compare Generalist and Specialist strategies on penetration of BI for patients scoring ≥2 on the CRAFFT substance use screen, delivered by the PCP in the Generalist sites, and via warm hand-off to a BHC in the Specialist sites.

Results: Approximately 62% of adolescent patient visits were screened with the CRAFFT (with <4% screening positive with a CRAFFT score ≥ 2). The Generalist Condition had significantly higher self-reported penetration of BI delivery than the Specialist Condition (38% vs. 8%; Adjusted Odds Ratio = 6.53; p = .005).

Discussion: Despite having co-located behavioral health services at all sites, a Specialist approach to providing BI was less effectively implemented than a Generalist approach in this FQHC. BI delivered by PCPs rather than by hand-off to a BHC may ensure greater penetration of these services in primary care settings. Both implementation models provided a framework for identifying and intervening with adolescent primary care patients whose substance use might have otherwise gone undetected.
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http://dx.doi.org/10.1016/j.jsat.2020.01.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7039979PMC
April 2020

Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine.

Addict Sci Clin Pract 2019 12 2;14(1):45. Epub 2019 Dec 2.

Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD, 20742, USA.

Background: It has been estimated that approximately 15% of people who are incarcerated in the US have histories of opioid use disorder. Relapse to opioid use after release from prison poses a serious risk of HIV infection. Prison-initiated buprenorphine may help to reduce HIV infection given the association between opioid use and HIV-risk behaviors.

Methods: The present study is a secondary analysis of longitudinal data gathered from a randomized controlled trial of buprenorphine-naloxone for people who were incarcerated (N = 211) between 2008 and 2012. It compares the impact of assignment to initiate buprenorphine in prison (N = 106 randomized, N = 104 analyzed) versus in the community (N = 107 randomized, N = 107 analyzed) and whether or not participants entered community treatment on the frequency of HIV-risk behaviors in the 12 months following release from prison. Data were analyzed hierarchically and for each outcome variable, a multilevel, over-dispersed Poisson model was fit to the data. Outcome variables were the number of times the following behaviors occurred in the last 30 days: (1) having sex without a condom (2) injecting drugs (3) using unsterilized needles, and (4) sharing injection paraphernalia.

Results: Participants assigned to begin buprenorphine in the community experienced a greater decrease in injection drug use over time compared to participants assigned to begin buprenorphine in prison. There were no significant associations between treatment assignment or community treatment entry and instances of having sex without a condom, sharing injection paraphernalia, or using unsterilized needles.

Conclusions: Overall, the present study did not find support for the initiation of buprenorphine in prison (as opposed to the community) as a means to reduce incidences of HIV-risk behaviors. Avenues for future research in the nexus of HIV-risk reduction, criminal justice, and pharmacotherapy are discussed. Trial registration This study was supported by the National Institute on Drug Abuse (NIDA), Buprenorphine for Prisoners (PI: Kinlock; R01DA021579). ClinicalTrials.gov identifier: NCT00574067.
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http://dx.doi.org/10.1186/s13722-019-0172-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886176PMC
December 2019

A Latent Class Analysis of HIV Risk Factors Among Men and Women with Opioid Use Disorder in Pre-trial Detention.

AIDS Behav 2020 Jun;24(6):1776-1783

Friends Research Institute, 1040 Park Ave, Suite 103, Baltimore, MD, 21201, USA.

Adults entering pre-trial detention who inject drugs are at high risk for acquiring HIV/AIDS. In the current study, we examined pre-incarceration HIV risk behaviors among 114 people with opioid use disorder who inject drugs. Participants were recruited from the Baltimore City Detention Center as part of a randomized controlled trial of pre-release methadone treatment. Using latent class analysis, we found three separate latent classes, which we identified as the sex exchange class (14.2%), drug equipment sharing class (36.8%) and lower risk class (49.0%). Women in the sex exchange class (n = 16) reported having multiple male partners and selling sex for money or drugs; however, this group also reported more consistent condom use and less frequent injection drug and equipment sharing than participants in the drug equipment sharing class. Our findings highlight distinct profiles of jail detainees with OUD based on their risks for HIV, and could inform more targeted interventions for each group.Clinical Trials Registration: Clinicaltrials.gov NCT02334215.
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http://dx.doi.org/10.1007/s10461-019-02726-yDOI Listing
June 2020

E-Cigarette Use Among Adult Primary Care Patients: Results from a Multisite Study.

J Gen Intern Med 2020 01 8;35(1):268-275. Epub 2019 Nov 8.

Department of Psychiatry and Behavioral Sciences, Division of Social and Community Psychiatry , Duke University Medical Center, Durham, NC, USA.

Background: Primary care settings provide opportunities to identify electronic-cigarette (e-cigarette) use and to implement strategies for changing tobacco use behavior. However, a better understanding of the extent and associated characteristics of e-cigarette use among primary care patients are needed to inform such efforts.

Objective: To describe patient demographic and substance use characteristics by e-cigarette use status among a large sample of primary care patients. To examine the prevalence and correlates of e-cigarette use among tobacco users in the sample.

Design: Cross-sectional analysis from a multisite validation study of a substance use screening instrument.

Participants: Adult primary care patients aged 18 and older (n = 2000) recruited across 5 primary care clinics in the Eastern USA from 2014 to 2015.

Main Measures: Patients reported past 3-month e-cigarette use, sociodemographics, tobacco use, and other substance use. Current nicotine dependence and DSM-5 criteria for past-year substance use disorders were also assessed.

Key Results: Among the total sample, 7.7% (n = 154) adults reported past 3-month e-cigarette use. Adults who reported e-cigarette use (vs. no use) were more likely to be younger, white, or have frequent tobacco use, nicotine dependence, or past-year illicit drug use/disorders. Among past 3-month tobacco users, 16.3% reported e-cigarette use. Adjusted logistic regression indicated that odds of e-cigarette use were greater among tobacco users who had some college education or more (vs. < high school) or were daily/almost daily tobacco users (vs. not); odds were lower among Blacks/African-Americans (vs. whites). E-cigarette use among tobacco users was associated with increased odds of current nicotine dependence or tobacco use disorder as well as more severe dependence/disorder.

Conclusions: Enhanced surveillance of e-cigarette use among adult tobacco users in primary care, particularly among those who use tobacco frequently, may have implications for helping patients with tobacco cessation using established approaches including behavioral support, pharmacotherapy, or referral to specialized care.
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http://dx.doi.org/10.1007/s11606-019-05488-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6957581PMC
January 2020

Electronic self-administered screening for substance use in adult primary care patients: feasibility and acceptability of the tobacco, alcohol, prescription medication, and other substance use (myTAPS) screening tool.

Addict Sci Clin Pract 2019 10 15;14(1):39. Epub 2019 Oct 15.

Department of Population Health, New York University (NYU) School of Medicine, 180 Madison Avenue, 17th floor, New York, NY, 10016, USA.

Background: The TAPS Tool is a substance use screening and brief assessment instrument that was developed for use in primary care medical settings. It is one of the first screening instruments to provide rapid assessment of all commonly used substance classes, including illicit and prescription opioids, and is one of the only available screeners designed and validated in an electronic self-administered format (myTAPS). This secondary analysis of data from the TAPS Tool validation study describes the feasibility and acceptability of the myTAPS among primary care patients.

Methods: Adult patients (N = 2000) from five primary care clinics completed the TAPS Tool on a tablet computer (myTAPS), and in an interviewer-administered format. Requests for assistance and time required were tracked, and participants completed a survey on ease of use, utilization of audio guidance, and format preference. Logistic regression was used to examine outcomes in defined subpopulations, including groups that may have greater difficulty completing an electronic screener, and those that may prefer an electronic self-administered approach.

Results: Almost all participants (98.3%) reported that the myTAPS was easy to use. The median time to complete myTAPS screening was 4.0 min (mean 4.48, standard deviation 2.57). More time was required by participants who were older, Hispanic, Black, or reported non-medical prescription drug use, while less time was required by women. Assistance was requested by 25% of participants, and was more frequently requested by those who with lower education (OR = 2.08, 95% CI 1.62-2.67) or age > 65 years (OR = 2.79, 95% CI 1.98-3.93). Audio guidance was utilized by 18.3%, and was more frequently utilized by participants with lower education (OR = 2.01, 95% CI 1.54-2.63), age > 65 years (OR = 1.79, 95% CI 1.22-2.61), or Black race (OR = 1.30, 95% 1.01-1.68). The myTAPS format was preferred by women (OR = 1.29, 95% CI 1.00-1.66) and individuals with drug use (OR = 1.43, 95% CI 1.09-1.88), while participants with lower education preferred the interviewer-administered format (OR = 2.75, 95% CI 2.00-3.78).

Conclusions: Overall, myTAPS screening was feasible and well accepted by adult primary care patients. Clinics adopting electronic screening should be prepared to offer assistance to some patients, particularly those who are older or less educated, and should have the capacity to use an interviewer-administered approach when required.
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http://dx.doi.org/10.1186/s13722-019-0167-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6794766PMC
October 2019

A novel telehealth platform for alcohol use disorder treatment: preliminary evidence of reductions in drinking.

Am J Drug Alcohol Abuse 2020 05 9;46(3):297-303. Epub 2019 Oct 9.

Friends Research Institute , Baltimore, MD, USA.

Background: Alcohol use disorder (AUD) treatment remains greatly underutilized. Innovative strategies are needed to improve AUD treatment access and patient engagement. The Ria Treatment Platform (RTP) is a patient-centered telemedicine AUD treatment program accessed through a smartphone application (app) that includes a package of physician visits (with AUD prescriptions as appropriate), text- and phone-based support from a recovery coach, video monitoring of medication adherence, and Bluetooth-linked breathalyzer tracking of alcohol intake.

Objectives: The purpose of the current study is to examine changes in alcohol use among patients utilizing the RTP.

Methods: This study examines daily breathalyzer blood alcohol content (BAC) readings collected from 77 adult patients (50.7% male) over the first 90 days in treatment with the RTP. Data were analyzed using dynamic structural equation modeling.

Results: The treatment retention rate at 90 days was 55%. The best fit for the BAC data was given by a cubic curve, which showed that among patients who remained engaged for 90 days average BAC levels declined approximately 50% (from .091 to .045) from baseline to day 90.

Conclusion: This study provides preliminary evidence of substantial alcohol use reductions among patients utilizing the RTP, an innovative telemedicine program accessed via smartphone. Although other alcohol-reduction apps have shown promise from scientific evaluations, the RTP appears to be the only app that incorporates physician-prescribed medication and a recovery coach. Research incorporating random assignment and meaningful comparison groups is needed to further evaluate this promising strategy.
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May 2020
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