Publications by authors named "Edward V Nunes"

210 Publications

COVID-19 related substance use services policy changes: Policymaker perspectives on policy development & implementation.

J Subst Abuse Treat 2021 Jun 25:108550. Epub 2021 Jun 25.

Columbia University School of Social Work, 1255 Amsterdam Ave., New York, NY 10027, United States of America. Electronic address:

Introduction: Due to the COVID-19 pandemic, regulations for substance use services changed to accommodate stay-at-home orders and physical distancing guidelines.

Methods: Using in-depth interviews (N = 14) and framework analysis, we describe how policymakers developed, adopted, and implemented regulations governing services for substance use disorders during COVID-19, and how policymakers' perceived the impacts of these regulations in New York State.

Results: During the COVID-19 pandemic, policymakers shifted to more inclusive approaches of knowledge generation and co-production of recommendations. Barriers to adoption and implementation of new regulations included medication/services supply, lack of integration, stigma, and overcriminalization.

Conclusion: Findings from this study highlight the potential feasibility and benefits of co-produced policies for substance use services and the need for consistent service supply, better integration with health care services, reduced stigma, improved funding structures, best practice guidelines, criminal justice reform, and harm reduction support. These considerations should inform future policy maintenance and modifications to substance use services related to COVID-19.
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http://dx.doi.org/10.1016/j.jsat.2021.108550DOI Listing
June 2021

Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment.

Am J Psychiatry 2021 Jul 25;178(7):660-671. Epub 2021 Jun 25.

New York State Psychiatric Institute and Columbia University Irving Medical Center, New York (Nunes, Scodes, Campbell); Department of Biostatistics, Columbia University Mailman School of Public Health, New York (Pavlicova); and New York University Grossman School of Medicine, New York (Lee, Novo, Rotrosen).

Objective: Sublingual buprenorphine-naloxone and extended-release injection naltrexone are effective treatments, with distinct mechanisms, for opioid use disorder. The authors examined whether patients' demographic and clinical characteristics were associated with better response to one medication or the other.

Methods: In a multisite 24-week randomized comparative-effectiveness trial of assignment to buprenorphine-naloxone (N=287) compared with extended-release naltrexone (N=283) comprising inpatients planning to initiate medication treatment for opioid use disorder, 50 demographic and clinical characteristics were examined as moderators of the effect of medication assignment on relapse to regular opioid use and failure to initiate medication. Moderator-by-medication interactions were estimated using logistic regression with correction for multiple testing.

Results: In the intent-to-treat sample, patients who reported being homeless had a lower relapse rate if they were assigned to receive extended-release naltrexone (51.6%) compared with buprenorphine-naloxone (70.4%) (odds ratio=0.45, 95% CI=0.22, 0.90); patients who were not homeless had a higher relapse rate if they were assigned to extended-release naltrexone (70.9%) compared with buprenorphine-naloxone (53.1%) (odds ratio=2.15, 95% CI=1.44, 3.21). In the subsample of patients who initiated medication, the interaction was not significant, with a similar pattern of lower relapse with extended-release naltrexone (41.4%) compared with buprenorphine (68.6%) among homeless patients (odds ratio=0.32, 95% CI=0.15, 0.68) but less difference among those not homeless (extended-release naltrexone, 57.2%; buprenorphine, 52.0%; odds ratio=1.24, 95% CI=0.80, 1.90). For failure to initiate medication, moderators were stated preference for medication (failure was less likely if the patient was assigned to the medication preferred), parole and probation status (fewer failures with extended-release naltrexone for those on parole or probation), and presence of pain and timing of randomization (more failure with extended-release naltrexone for patients endorsing moderate to severe pain and randomized early while still undergoing medically managed withdrawal).

Conclusions: Among patients with opioid use disorder admitted to inpatient treatment, homelessness, parole and probation status, medication preference, and factors likely to influence tolerability of medication initiation may be important in matching patients to buprenorphine or extended-release naltrexone.
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http://dx.doi.org/10.1176/appi.ajp.2020.20060816DOI Listing
July 2021

Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder.

Alcohol Clin Exp Res 2021 Jun 12. Epub 2021 Jun 12.

Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, USA.

Background: Despite advances in the development of pharmacotherapy for alcohol use disorder (AUD), there remains a need for medications that can be administered to actively drinking outpatients to promote a reduction in harmful alcohol consumption. The primary aim of this pilot study was to determine whether high-dose gabapentin (3600 mg/daily) is more effective than placebo in reducing harmful alcohol consumption in outpatients with AUD.

Methods: Forty patients (27 men) who met DSM-IV-TR criteria for alcohol dependence and reporting at least 4 heavy drinking days (HDD) per week were recruited at a single site. Participants were actively drinking at study entry and received double-blind gabapentin (3600 mg/day; n = 19) or placebo (n = 20) for 8 weeks. Study medication was titrated over 5 days and administered in three divided doses (1200 mg three times per day). The proportion of HDD (primary outcome) and percent days abstinent (PDA; secondary outcome) were analyzed using generalized longitudinal mixed models with the predictors being study arm, week, study arm by week interaction, and corresponding baseline drinking measure.

Results: There was a significant interaction between study arm and week for the proportion of HDD per week, F (7, 215) = 3.33, p = 0.002 . There was also a significant interaction between study arm and week for PDA per week, F (7, 215) = 3.11, p = 0.004. The overall retention rate was 67.5% with no significant difference in time-to-dropout between treatment groups. There were no serious adverse events. No participants were removed from the trial due to the development of moderate-to-severe alcohol withdrawal (CIWA-Ar ≥ 13).

Conclusions: Gabapentin treatment rapidly titrated to a dosage of 3600 mg/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD. High-dose gabapentin is potentially a feasible approach to treating AUD and deserving of further study.
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http://dx.doi.org/10.1111/acer.14648DOI Listing
June 2021

Reductions in tobacco use in naltrexone, relative to buprenorphine-maintained individuals with opioid use disorder: Secondary analysis from the National Drug Abuse Treatment Clinical Trials Network.

J Subst Abuse Treat 2021 May 21;130:108489. Epub 2021 May 21.

Department of Psychiatry, NYU Grossman School of Medicine, One Park Avenue, New York, NY 10016, USA.

Background: Smoking prevalence in individuals with opioid use disorder (OUD) is over 80%. Research suggests that opioid use significantly increases smoking, which could account for the strikingly low smoking-cessation rates observed in both methadone- and buprenorphine-maintained patients, even with the use of first-line smoking-cessation interventions. If opioids present a barrier to smoking-cessation, then better smoking outcomes should be observed in OUD patients treated with extended-release naltrexone (XR-NTX, an opioid antagonist) compared to those receiving buprenorphine (BUP-NX, a partial opioid agonist).

Methods: The current study is a secondary analysis of a 24-week, multi-site, open-label, randomized clinical trial conducted within the National Drug Abuse Treatment Clinical Trials Network comparing the effectiveness of XR-NTX vs. BUP-NX for adults with OUD. Longitudinal mixed effects models were used to determine if there was a significant reduction in cigarette use among daily smokers successfully inducted to treatment (n = 373) and a subset of those who completed treatment (n = 169).

Results: Among daily smokers inducted onto OUD medication, those in the XR-NTX group smoked fewer cigarettes per day (M = 11.36, SE = 0.62) relative to smokers in the BUP-NX group (M = 13.33, SE = 0.58) across all study visits, (b (SE) = -1.97 (0.55), p < .01). Results were similar for the treatment completers.

Conclusions: OUD patients treated with XR-NTX reduced cigarette use more than those treated with BUP-NX, suggesting that XR-NTX in combination with other smoking cessation interventions might be a better choice for OUD smokers interested in reducing their tobacco use.
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http://dx.doi.org/10.1016/j.jsat.2021.108489DOI Listing
May 2021

Naturalistic follow-up after a trial of medications for opioid use disorder: Medication status, opioid use, and relapse.

J Subst Abuse Treat 2021 Apr 30;131:108447. Epub 2021 Apr 30.

New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY 10032, United States of America. Electronic address:

Aim: This report examined naturalistic opioid use outcomes and utilization of medications for opioid use disorder (MOUD) 36 weeks post-randomization in the National Drug Abuse Treatment Clinical Trials Network (CTN) Extended-Release Naltrexone (XR-NTX) versus Buprenorphine-Naloxone (BUP-NX) for Opioid Treatment trial (CTN-0051, X:BOT).

Design: X:BOT was a multisite, randomized, 24-week comparative effectiveness trial of BUP-NX (N = 287) and XR-NTX (N = 283). Study medications were discontinued following treatment completion, relapse, or dropout. Participants were encouraged to continue MOUD. This report examined opioid use outcomes in 428 (75%) of the 570 participants who attended the 36-week follow-up visit.

Setting And Participants: Adults with opioid use disorder recruited from 8 community treatment programs across the United States.

Measurements: Outcomes included medication status (on/off MOUD), type of MOUD (BUP-NX, XR-NTX, or methadone), abstinence from non-prescribed opioids, opioid use days, relapse, and other substance use 30 days prior to the 36-week visit. Relapse was defined as opioid use for 4 consecutive weeks or 7 consecutive days in the past month. Baseline and clinical variables included opioid use severity, intravenous drug use, study medication assignment, and induction status.

Findings: Of the 428 participants who completed the 36-week visit, 225 (53%) of participants were receiving MOUD and 203 (47%) were not. Compared to those off medication, participants on medication had fewer opioid use days (4.4 days (SD 9.0) versus 9.8 days (SD 12.1)), fewer met relapse criteria (37 (16.4%) versus 79 (38.9%)), and reported less stimulant use (34 (15.2%) versus 56 (27.7%)) and sedative use (14 (6.3%) versus 31 (15.3%)). There was no difference in abstinence rates between those on or off MOUD. A greater proportion of participants on XR-NTX (47 (53.4%) of 88 participants) were abstinent from non-prescribed opioids compared to those on buprenorphine (28 (23.3%) of 120 participants).

Conclusions: Naturalistic outcomes data showed that despite potential barriers to continuing treatment in the community, about half of individuals were on opioid use disorder pharmacotherapy at follow-up and those on medication generally had better outcomes. Future research should explore barriers and facilitators to treatment retention in community settings; and developing interventions tailored to improve treatment engagement and adherence.
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http://dx.doi.org/10.1016/j.jsat.2021.108447DOI Listing
April 2021

Cost-effectiveness implications of increasing the efficiency of the extended-release naltrexone induction process for the treatment of opioid use disorder: a secondary analysis.

Addiction 2021 May 5. Epub 2021 May 5.

Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.

Background And Aims: In a US randomized-effectiveness trial comparing extended-release naltrexone (XR-NTX) with buprenorphine-naloxone (BUP-NX) for the prevention of opioid relapse among participants recruited during inpatient detoxification (CTN-0051), the requirement to complete opioid detoxification prior to initiating XR-NTX resulted in lower rates of initiation of XR-NTX (72% XR-NTX versus 94% BUP-NX).

Design: This was a retrospective secondary analysis of CTN-0051 trial data, including follow-up data over 24-36 weeks.

Setting: Eight community-based, inpatient-detoxification and follow-up outpatient treatment facilities in the United States.

Participants: A total of 283 participants randomized to receive XR-NTX.

Measurements: Efficiency was estimated using a multivariable generalized structural equation model to explore simultaneous determinants of XR-NTX induction and induction duration (detoxification + residential days). Cost-effectiveness was estimated from the health-care sector perspective and included expected costs and quality-adjusted life-years (QALYs).

Findings: Treatment site was the only modifiable factor that simultaneously increased the likelihood of XR-NTX induction and decreased induction duration. Incorporating the higher predicted probability of XR-NTX induction, and fewer predicted days of detoxification and subsequent residential treatment into the cost-effectiveness framework, reduced the incremental average 24-week total cost of XR-NTX treatment from $5317 more than that of BUP-NX (P = 0.01) to a non-statistically-significant difference of $1016 (P = 0.63). QALYs gained remained similar across arms.

Conclusion: Adopting an efficient model of extended-release naltrexone initiation could result in extended-release naltrexone and buprenorphine-naloxone being of comparable economic value from the health-care sector perspective over 24-36 weeks for patients seeking treatment for opioid use disorder at an inpatient detoxification facility.
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http://dx.doi.org/10.1111/add.15531DOI Listing
May 2021

Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.

Contemp Clin Trials 2021 Jun 7;105:106394. Epub 2021 Apr 7.

Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA. Electronic address:

Background: Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge.

Methods: A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose.

Results: We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial.

Conclusions: Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population.
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http://dx.doi.org/10.1016/j.cct.2021.106394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8172465PMC
June 2021

Association between methadone or buprenorphine use during medically supervised opioid withdrawal and extended-release injectable naltrexone induction failure.

J Subst Abuse Treat 2021 05 16;124:108292. Epub 2021 Jan 16.

New York State Psychiatric Institute, United States of America; Department of Psychiatry, Columbia University Medical Center, United States of America.

Background: Extended-release naltrexone (XR-NTX) is an effective maintenance treatment for opioid use disorder, but induction from active opioid use is a challenge as individuals must complete detoxification before induction. We aimed to determine whether use of methadone or buprenorphine, long acting agonist opioids commonly used for detoxification, were associated with decreased likelihood of induction onto XR-NTX.

Methods: We performed a secondary analysis of a large open-label randomized trial of buprenorphine versus XR-NTX for treatment of individuals with opioid use disorder recruited from eight short term residential (detoxification) units. This analysis only included individuals randomized to the XR-NTX arm of the trial (N = 283). The method of detoxification varied according to usual practices at each inpatient program. Logistic regression models estimating the log-odds of induction onto XR-NTX were fit, with detoxification regimen received as the predictor.

Results: In the unadjusted logistic regression model, detoxification drug received (either methadone or buprenorphine) was significantly associated with decreased likelihood of induction onto XR-NTX compared to receiving non-opioid detoxification (Overall: P < 0.001); buprenorphine vs non-opioid detoxification: OR (95% CI) = 0.32 (0.15-0.67); methadone vs non-opioid detoxification: OR (95% CI) = 0.23 (0.11-0.46). After controlling for site as a random effect, the association of detoxification drug with induction success lost statistical significance.

Conclusions: Use of agonist medication during detoxification was associated with XR-NTX induction failure. Medication choice was determined by each site's clinical practice and therefore this association could not be separated from other site level variables.

Clinical Trial Registration: NCT02032433.
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http://dx.doi.org/10.1016/j.jsat.2021.108292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8004552PMC
May 2021

Prior National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder trials as background and rationale for NIDA CTN-0100 "optimizing retention, duration and discontinuation strategies for opioid use disorder pharmacotherapy (RDD)".

Addict Sci Clin Pract 2021 03 6;16(1):15. Epub 2021 Mar 6.

New York State Psychiatric Institute and Columbia University Irving Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.

Opioid use disorder continues to be a significant problem in the United States and worldwide. Three medications-methadone, buprenorphine, and extended-release injectable naltrexone,- are efficacious for treating opioid use disorder (OUD). However, the utility of these medications is limited, in part due to poor rates of retention in treatment. In addition, minimum recovery milestones and other factors that influence when and whether individuals can safely discontinue medications are unknown. The National Drug Abuse Treatment Clinical Trials Network (CTN) study "Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy" (RDD; CTN-0100) will be among the largest clinical trials on treatment of OUD yet conducted, consisting of two phases, the Retention phase, and the Duration-Discontinuation phase. The Retention phase, open to patients initiating treatment, will test different doses and formulations of buprenorphine (standard dose sublingual, high dose sublingual, or extended-release injection), and a digital therapeutic app delivering contingency management and cognitive behavioral counseling on the primary outcome of retention in treatment. The Discontinuation phase, open to patients in stable remission from OUD and choosing to discontinue medication (including participants from the Retention phase or from the population of patients treated at the clinical site, referred by an outside prescriber or self-referred) will study different tapering strategies for buprenorphine (sublingual taper vs taper with injection buprenorphine), and a digital therapeutic app which provides resources to promote recovery, on the primary outcome of relapse-free discontinuation of medication. This paper describes how the RDD trial derives from two decades of research in the CTN. Initial trials (CTN-0001; CTN-0002; CTN-0003) focused on opioid detoxification, showing buprenorphine-naloxone was effective for detoxification, but that acute detoxification did not appear to be an effective treatment strategy. Trials on comparative effectiveness of medications for opioid use disorder (MOUD) (CTN-0027; CTN-0030; and CTN-0051) highlighted the problem of dropout from treatment and few trials defined retention on MOUD as the primary outcome. Long-term follow-up studies on those patient samples demonstrated the importance of long-term continuation of medication for many patients to sustain remission. Overall, these trials highlight the potential of a stable research infrastructure such as CTN to advance treatment effectiveness through a programmatic succession of large clinical trials.
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http://dx.doi.org/10.1186/s13722-021-00223-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7936466PMC
March 2021

Workshop on Implementation Science and Digital Therapeutics for Behavioral Health.

JMIR Ment Health 2021 Jan 28;8(1):e17662. Epub 2021 Jan 28.

Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth College, Lebanon, NH, United States.

Digital therapeutics can overcome many of the barriers to translation of evidence-based treatment for substance use, mental health, and other behavioral health conditions. Delivered via nearly ubiquitous platforms such as the web, smartphone applications, text messaging, and videoconferencing, digital therapeutics can transcend the time and geographic boundaries of traditional clinical settings so that individuals can access care when and where they need it. There is strong empirical support for digital therapeutic approaches for behavioral health, yet implementation science with regard to scaling use of digital therapeutics for behavioral health is still in its early stages. In this paper, we summarize the proceedings of a day-long workshop, "Implementation Science and Digital Therapeutics," sponsored and hosted by the Center for Technology and Behavioral Health at Dartmouth College. The Center for Technology and Behavioral Health is an interdisciplinary P30 Center of Excellence funded by the National Institute on Drug Abuse, with the mission of promoting state-of-the-technology and state-of-the-science for the development, evaluation, and sustainable implementation of digital therapeutic approaches for substance use and related conditions. Workshop presentations were grounded in current models of implementation science. Directions and opportunities for collaborative implementation science research to promote broad adoption of digital therapeutics for behavioral health are offered.
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http://dx.doi.org/10.2196/17662DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878106PMC
January 2021

Bupropion and Naltrexone in Methamphetamine Use Disorder.

N Engl J Med 2021 01;384(2):140-153

From the Peter O'Donnell Jr. Brain Institute at the University of Texas Southwestern Medical Center (M.H.T.) and the University of Texas Southwestern Medical Center (R.W., A.C., T.C., M.K., K.S.-W., S.W.), Dallas, the University of Texas Health Science Center at Houston, Houston (J.S.), and Texas Tech University, Permian Basin, Odessa (A.J.R.); the University of California, Los Angeles, Los Angeles (W.L., S. Shoptaw); the Emmes Company, Rockville (G.S., A.W.), and the National Institute on Drug Abuse Center for the Clinical Trials Network (U.E.G., S. Sparenborg [retired]), Rockville - both in Maryland; the San Francisco Department of Public Health and the University of California, San Francisco, San Francisco (P.C.); CODA, Portland, OR (K.W.); Hennepin Healthcare, University of Minnesota, Minneapolis (G.B.); Medical University of South Carolina, Charleston (S.C.S.); Duke-National University of Singapore, Singapore (A.J.R.); Duke Medical School, Durham, NC (A.J.R.); and Columbia University, New York (E.V.N.).

Background: The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.

Methods: We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.

Results: A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.

Conclusions: Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).
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http://dx.doi.org/10.1056/NEJMoa2020214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111570PMC
January 2021

The utility of a formative one-station objective structured clinical examination for Substance use disorders in a dental curriculum.

Eur J Dent Educ 2021 Jan 20. Epub 2021 Jan 20.

Division on Substance Use Disorders, New York State Psychiatric Institute, Columbia University, New York, NY, USA.

Substance use disorders (SUD) are chronic relapsing medical conditions characterised by compulsive substance seeking and use. They constitute a substantial disease burden globally. Labelling of persons with SUD has created barriers to treatment but there are effective management strategies. The dental profession has embraced reforms designed to address the SUD epidemic by promoting continuing education for practitioners and initiating curriculum changes in dental schools. Screening, Brief Intervention and Referral to Treatment (SBIRT) is an evidence-based model for managing patients with SUD. The use of a formative 1-station Objective Structured Clinical Examination (OSCE) for learning and assessment in SBIRT, operationalised with the MD3 rating scale is presented in this study. In 3 years of implementation, the SBIRT OSCE successfully integrated into the curriculum of the College of Dental Medicine, Columbia University. Mean score of total adherent behaviours was 11.80 (SD =4.23) (range: 2 - 24) and Cronbach's coefficient alpha for across-items reliability in adherent behaviours was 0.66. Adherent behaviours correlated with the global ratings (r = 0.66). Mean of global rating scores were 2.90 (SD =1.01) for collaboration and 2.97 (SD =1.00) for empathy and the global rating scores correlated with each other (r = 0.85). Histograms of global rating scores resembled normal distribution. The 1-station OSCE is a good model for learning about SBIRT. Psychometric analysis was useful in understanding the underlying construct of the MD3 rating scale and supported its reliability, validity and utility in dental education.
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http://dx.doi.org/10.1111/eje.12661DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8289927PMC
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

Explaining differential effects of medication for opioid use disorder using a novel approach incorporating mediating variables.

Addiction 2021 Aug 22;116(8):2094-2103. Epub 2021 Jan 22.

Department of Psychiatry, School of Medicine, Columbia University and New York State Psychiatric Institute, New York, NY, USA.

Background And Aims: A recent study found that homeless individuals with opioid use disorder (OUD) had a lower risk of relapse on extended-release naltrexone (XR-NTX) versus buprenorphine-naloxone (BUP-NX), whereas non-homeless individuals had a lower risk of relapse on BUP-NX. This secondary study examined differences in mediation pathways to medication effect between homeless and non-homeless participants.

Design: Secondary analysis of an open-label randomized controlled, 24-week comparative effectiveness trial, 2014-17.

Setting: Eight community addiction treatment programs in the United States.

Participants: English-speaking adults with DSM-5 OUD, recruited during inpatient admission (n = 570).

Intervention(s): Randomization to monthly injection of XR-NTX or daily sublingual BUP-NX.

Measurements(s): Mediation analysis estimated the direct effect of XR-NTX versus BUP-NX on relapse and indirect effect through mediators of medication adherence, use of illicit opioids, depressive symptoms and pain, separately by homeless status.

Findings: For the homeless subgroup, the protective indirect path contributed a 3.4 percentage point reduced risk of relapse [95% confidence interval (CI) = -12.0, 5.3] comparing XR-NTX to BUP-NX (explaining 21% of the total effect). For the non-homeless subgroup, the indirect path contributed a 9.4 percentage point increased risk of relapse (95% CI = 3.1, 15.7) comparing XR-NTX to BUP-NX (explaining 57% of the total effect).

Conclusions: A novel approach to mediation analysis shows that much of the difference in medication effectiveness (extended-release naltrexone versus buprenorphine-naloxone) on opioid relapse among non-homeless adults with opioid use disorder appears to be explained by mediators of adherence, illicit opioid use, depressive symptoms and pain.
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http://dx.doi.org/10.1111/add.15377DOI Listing
August 2021

Medication treatment for opioid use disorder in the age of COVID-19: Can new regulations modify the opioid cascade?

J Subst Abuse Treat 2021 03 14;122:108196. Epub 2020 Nov 14.

Columbia Center for Healing of Opioid and Other Substance Use Disorders - Enhancing Intervention Development and Implementation (CHOSEN), Riverside Drive, New York, NY 10032, United States of America; Columbia School of Social Work, 1255 Amsterdam Ave, New York, NY 10027, United States of America.

The temporary loosening of regulations governing methadone and buprenorphine treatment for opioid use disorder (OUD) in the U.S., instituted to prevent the spread of COVID-19, has created an opportunity to explore the effectiveness of new models of care for people with OUD. The opioid cascade describes the current status of the treatment system, where only a fraction of people with OUD initiate effective medication treatment for OUD (MOUD), and of those only a fraction is retained in treatment. Regulatory changes-such as availability of larger take-home supplies of methadone and buprenorphine initiated via telemedicine (e.g., no initial in person visit; telemedicine buprenorphine permitted across state lines)-could modify the cascade, by reducing the burden and increasing the attractiveness, availability, and feasibility of MOUD both for people with OUD and for providers. We review examples of more liberal MOUD regimens, including the implementation of buprenorphine in France in the 1990s, primary care-based methadone in Canada, and low-threshold buprenorphine models. Research is needed to document whether new models implemented in the U.S. in the wake of COVID-19 are successful, and whether safety concerns, such as diversion and misuse, emerge. We discuss barriers to implementation, including racial and ethnic health disparities, and lack of knowledge and reluctance among potential providers of MOUD. We suggest that the urgency and public spiritedness of the response to COVID-19 be harnessed to make gains on the opioid cascade, inspiring prescribers, health systems, and communities to embrace the delivery of MOUD to meet the needs of an increasingly vulnerable population.
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http://dx.doi.org/10.1016/j.jsat.2020.108196DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666540PMC
March 2021

Quetiapine treatment for cannabis use disorder.

Drug Alcohol Depend 2021 01 20;218:108366. Epub 2020 Oct 20.

New York State Psychiatric Institute, Division on Substance Use Disorders, 1051 Riverside Drive, New York, NY, 10032, USA; Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, 630 West 168th Street, New York, NY, 10032, USA.

Backround: Pharmacotherapy for cannabis use disorder (CUD) is an important unmet public health need.

Methods: In a 12-week randomized double-blind placebo-controlled trial, the efficacy of quetiapine (300 mg nightly) for the treatment of CUD was tested in 130 outpatients. Weekly cannabis use was categorized into three groups: heavy use (5-7 days), moderate use (2-4 days) and light use (0-1 days).

Results: At baseline both groups were considered heavy users (using days per week: median = 7.0; interquartile range (IQR): 6.5-7.0; daily dollar value: median = $121.4; IQR: 73.8-206.3). The week-by-treatment interaction was marginally significant (χ(2) = 5.56, P = .06). With each week, the odds of moderate compared to heavy use significantly increased in the quetiapine group (OR=1.17, P < .0001), but not significantly in the placebo group (OR=1.05, P = .16). The odds of light versus heavy use did not significantly differ over time (P = .12). Treatment was also associated with reduced cannabis withdrawal symptoms by 10.4% each week (95% CI: 8.9-11.8). No serious adverse events occurred during the study and no evidence of development of a movement disorder was detected. Adverse effects were not significantly different between the quetiapine and placebo treatment arms.

Conclusions: The use of quetiapine to treat CUD was associated with an increased likelihood of heavy frequency use transitioning to moderate use, but not light use. The clinical significance of reductions in cannabis use, short of abstinence warrants further study.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.108366DOI Listing
January 2021

Addiction Psychiatry and Addiction Medicine: The Evolution of Addiction Physician Specialists.

Am J Addict 2020 09;29(5):390-400

Section of General Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.

Addiction Psychiatry and Addiction Medicine are two physician subspecialities recognized by the American Board of Medical Specialties (ABMS) that focus on providing care for patients with substance use disorders. Their shared and distinct historical roots are reviewed, and their respective ABMS board examination content areas and Accreditation Council on Graduate Medical Education (ACGME) fellowship training program requirements are compared. Addiction Psychiatry, a subspecialty under the American Board of Psychiatry and Neurology, began certifying diplomates in 1993, currently has 1202 active diplomates, and certifies around 150 diplomates every 2 years through 50 ACGME-accredited fellowships. Addiction Medicine, a subspecialty under the American Board of Preventive Medicine, began certifying diplomates in 2018, has 2604 diplomates with more expected before the practice pathway closes (anticipated in 2021), after which a fellowship training becomes required. Currently there are 78 accredited Addiction Medicine fellowships and more under development. The fields display substantial overlap between their respective examination content areas and fellowship training requirements, covering similar knowledge and skills for evaluation and treatment of substance use disorders and psychiatric and medical comorbidities across the full range of clinical settings, from general medical to addiction specialty settings. Key differences include that Addiction Psychiatry is open only to Board-certified psychiatrists and places extra emphasis on psychotherapeutic and psychopharmacological management strategies. Addiction Medicine is open to any ABMS primary specialty, including psychiatry. Opportunities for collaboration are discussed as both fields pursue the common goal of providing a well-trained workforce of physicians to meet the public health challenge presented by addiction. (Am J Addict 2020;00:00-00).
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http://dx.doi.org/10.1111/ajad.13068DOI Listing
September 2020

Variants of opioid genes and response to treatment of opioid use disorder with buprenorphine-naloxone versus extended-release naltrexone in Caucasians.

Am J Drug Alcohol Abuse 2020 11 27;46(6):761-768. Epub 2020 Aug 27.

Laboratory of the Biology of Addictive Diseases, the Rockefeller University , New York, NY, USA.

: Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD), combines buprenorphine (a partial mu/kappa agonist) with naloxone (a mu/ kappa antagonist). Extended-release injection naltrexone (XR-NTX; a mu receptor antagonist and kappa receptor partial agonist) is also an FDA-approved treatment for OUD. However, while some patients respond well to these medications, many others leave treatment and relapse. : Determine whether gene variants in the opioid gene system are associated with better or worse treatment response. : In a 24-week, multisite, randomized, comparative effectiveness trial of daily, sublingual self-administration of BUP-NX versus monthly injection of XR-NTX conducted in the National Drug Abuse Clinical Trials Network, DNA was collected and four opioid gene variants were evaluated: (1) mu opioid receptor 118A>G; (2) 68-bp repeat in prodynorphin; (3) prodynorphin SNP rs910080; and (4) kappa opioid receptor SNP rs6473797. In non-Hispanic Caucasians ( = 334), two outcomes measures were assessed: received first dose (yes/no) and received last dose (yes/no). Separate logistic regressions were used to model each outcome measure as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction. : There were no significant main effects of gene variant on receiving first dose or last dose. There were also no significant gene variant by treatment interactions. : The outcome of treatment of OUD with medications is likely a complex function of multiple factors, including environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.
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http://dx.doi.org/10.1080/00952990.2020.1797064DOI Listing
November 2020

Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.

Drug Alcohol Depend 2020 10 5;215:108221. Epub 2020 Aug 5.

Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.

Objective: To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.

Methods: We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.

Results: We identified two subpopulations: HRQoL "pharmacotherapy responsive" (82.3 %) and HRQoL "characteristic sensitive" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.

Conclusion: Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.
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http://dx.doi.org/10.1016/j.drugalcdep.2020.108221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502461PMC
October 2020

Medical Student Attitudes Toward Substance Use Disorders Before and After a Skills-Based Screening, Brief Intervention, and Referral to Treatment (SBIRT) Curriculum.

Adv Med Educ Pract 2020 30;11:455-461. Epub 2020 Jun 30.

Department of Psychiatry, Columbia University, New York, NY, USA.

Purpose: Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based framework for assessing and addressing risky substance use. This study evaluated the substance-related attitudes of medical students who participated in an Enhanced Pre-Clinical SBIRT Curriculum designed to reduce stigma, help students empathize with the experiences of people using alcohol and drugs, understand substance use in-context, and feel more optimistic about efforts to prevent and treat substance use disorders (SUDs).

Methods: Students (N=118; 73.8% of eligible) completed the Attitudes and Opinions Survey for alcohol and drugs before and after this 2-year, multi-modality curriculum. The authors classified attitudes as "positive" or "negative" and grouped students by pre-post attitudinal change: persistently negative, persistently positive, negative-to-positive, positive-to-negative. Using chi-square tests, the authors assessed differences by sex, race/ethnicity, and whether students had a family member or friend with an SUD.

Results: Most students (>90%) reported persistently positive attitudes regarding physicians in recovery, societal contributions of patients with SUDs; ability to learn from such patients; and general attitudes toward SUD treatment. This skewed distribution precluded the investigation of subgroup differences. Fewer students reported persistently positive attitudes regarding SUD patients' healthcare utilization (alcohol 58.5%; drug 57.8%) and impact on other patients' care (alcohol 73.7%; drug 72.4%), compared to other attitudinal domains (at p-values < 0.0001 in the McNemar's tests). Approximately, 1 in 5 students reported more negative healthcare utilization attitudes on follow-up. There were no demographic differences in these two attitudinal domains.

Conclusion: Unlike previous studies of medical student attitudes, most students who participated in the Enhanced Pre-Clinical SBIRT Curriculum reported an enduring appreciation for the educational and societal contributions of patients with SUDs. Attitudes toward healthcare utilization and the impact of patients with SUDs on the care of other patients were more resistant to change, possibly due to the predominance of acute-care inpatient settings in clinical training.
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http://dx.doi.org/10.2147/AMEP.S251391DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335270PMC
June 2020

COVID-19, mental health, and opioid use disorder: Old and new public health crises intertwine.

Psychol Trauma 2020 Aug 18;12(S1):S111-S112. Epub 2020 Jun 18.

School of Social Work.

The United States is facing both the coronavirus disease 2019 (COVID-19) pandemic and an ongoing epidemic of opioid overdose. Opioid use disorder is associated with other mental health problems, trauma, and social and health disparities. While the United States has acted to improve access to treatment for mental health and opioid use, research will be needed to understand the effectiveness of new policies in the context of COVID-19. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/tra0000660DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7583654PMC
August 2020

Substance Use and Mental Health in Emerging Adult Vs Older Adult Men and Women With Opioid Use Disorder.

Am J Addict 2020 11 21;29(6):536-542. Epub 2020 May 21.

Department of Psychiatry, Harvard Medical School, McLean Hospital, Belmont, Massachusetts.

Background And Objectives: We examined age differences across genders in clinical characteristics in emerging adult (≤25 years) vs older adult patients (26+ years) with opioid use disorder (OUD).

Methods: Participants (N = 570; 30% female) entering a comparative effectiveness medication trial of buprenorphine vs extended-release naltrexone.

Results: Differences in clinical characteristics in emerging adult vs older participants were similar across genders. However, women 26+ years reported more mental health problems compared with women ≤25, while men ≤25 years reported more mental health problems compared with men 26+ years.

Discussion And Conclusion: Different strategies for emerging adult and older patients seeking OUD treatment may be necessary to address psychiatric comorbidities that differ across genders in this population.

Scientific Significance: Comprehensive psychiatric assessment should be systematically included in OUD treatment for all genders. Treatment should focus on the emerging adult developmental phase when appropriate, with psychiatric treatment tailored for women and men, separately, across the lifespan. (Am J Addict 2020;29:536-542).
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http://dx.doi.org/10.1111/ajad.13059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7657988PMC
November 2020

Exploring gender differences among treatment-seekers who use opioids versus alcohol and other drugs.

Women Health 2020 08 31;60(7):821-838. Epub 2020 Mar 31.

Department of Psychiatry and New York State Psychiatric Institute, Columbia University Medical Center , New York, NY, USA.

Identifying clinical differences between opioid users (OU) and alcohol and other drug users (AOD) may help to tailor treatment to OU, particularly among the majority of OU who are not on opioid agonist treatments. Given the dearth of research on these differences, this study explored gender differences in demographic and clinical characteristics between OU and AOD. Participants (N = 506) were from a multisite, randomized controlled clinical trial of an Internet-delivered psychosocial intervention conducted in 2010-2011. Logistic regression models explored differences in demographic and clinical characteristics by substance use category within and between women and men. Women OU were more likely to be younger, White, employed, benzodiazepine users, and less likely to have children or use cocaine and cannabis than women AOD. Men OU, compared to men AOD, were more likely to be younger, White, younger at first abuse/dependence, benzodiazepine users, and reported greater psychological distress, but were less likely to be involved in criminal justice or use stimulants. Interactions by gender and substance use were also detected for age of first abuse/dependence, employment, and criminal justice involvement. These findings provide a nuanced understanding of gender differences within substance use groups to inform providers for OU seeking treatment.
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http://dx.doi.org/10.1080/03630242.2020.1746952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7332367PMC
August 2020

The "Women and Trauma" study and its national impact on advancing trauma specific approaches in community substance use treatment and research.

J Subst Abuse Treat 2020 03;112S:12-17

Department of Psychiatry, Columbia University Irving Medical Center and Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States of America.

Introduction: The "Women and Trauma" Study (WTS) conducted in the National Drug Abuse Treatment Clinical Trials Network (CTN-0015) resulted in research publications, presentations, and a train-the-trainer workshop to support dissemination efforts for skills-based trauma treatment in substance use community treatment. Twelve years after its completion, this paper aims to examine whether and how the WTS contributed to knowledge in the field of trauma and addictions and inspired community treatment programs (CTPs) to train staff to identify and provide trauma-related services.

Method: We present findings from two different analyses that explored longer term study impacts on treatment and dissemination: (1) a post-study site survey covering 4 domains from 4/7 programs that participated in delivering the WTS to evaluate their perceptions of study impact on their treatment community; and (2) an analysis of citations of its publications to determine impact on the scientific community.

Results: Surveys from responding sites indicated that participation in the study significantly increased their agencies'' awareness of the need to take a focused approach to treating trauma issues in this population. Specifically, these sites increased their commitment to using skills-based trauma treatment with the study's target population of female patients with SUD and trauma histories, as well as expanding it to other groups affected by trauma. Citation analysis revealed that according to the Web of Science, as of August 2019, the number of citations of 24 CTN-0015 articles, ranged from 1 to 135 (Mean = 20, SD = 33; Median = 6). Four of the most influential are discussed.

Conclusions: This manuscript provides original information about the contributions of the WTS study, demonstrating how the study contributed to serving women with trauma in community substance use treatment.
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http://dx.doi.org/10.1016/j.jsat.2020.02.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7123457PMC
March 2020

Workshop on the Development and Evaluation of Digital Therapeutics for Health Behavior Change: Science, Methods, and Projects.

JMIR Ment Health 2020 Feb 26;7(2):e16751. Epub 2020 Feb 26.

Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.

The health care field has integrated advances into digital technology at an accelerating pace to improve health behavior, health care delivery, and cost-effectiveness of care. The realm of behavioral science has embraced this evolution of digital health, allowing for an exciting roadmap for advancing care by addressing the many challenges to the field via technological innovations. Digital therapeutics offer the potential to extend the reach of effective interventions at reduced cost and patient burden and to increase the potency of existing interventions. Intervention models have included the use of digital tools as supplements to standard care models, as tools that can replace a portion of treatment as usual, or as stand-alone tools accessed outside of care settings or direct to the consumer. To advance the potential public health impact of this promising line of research, multiple areas warrant further development and investigation. The Center for Technology and Behavioral Health (CTBH), a P30 Center of Excellence supported by the National Institute on Drug Abuse at the National Institutes of Health, is an interdisciplinary research center at Dartmouth College focused on the goal of harnessing existing and emerging technologies to effectively develop and deliver evidence-based interventions for substance use and co-occurring disorders. The CTBH launched a series of workshops to encourage and expand multidisciplinary collaborations among Dartmouth scientists and international CTBH affiliates engaged in research related to digital technology and behavioral health (eg, addiction science, behavioral health intervention, technology development, computer science and engineering, digital security, health economics, and implementation science). This paper summarizes a workshop conducted on the Development and Evaluation of Digital Therapeutics for Behavior Change, which addressed (1) principles of behavior change, (2) methods of identifying and testing the underlying mechanisms of behavior change, (3) conceptual frameworks for optimizing applications for mental health and addictive behavior, and (4) the diversity of experimental methods and designs that are essential to the successful development and testing of digital therapeutics. Examples were presented of ongoing CTBH projects focused on identifying and improving the measurement of health behavior change mechanisms and the development and evaluation of digital therapeutics. In summary, the workshop showcased the myriad research targets that will be instrumental in promoting and accelerating progress in the field of digital health and health behavior change and illustrated how the CTBH provides a model of multidisciplinary leadership and collaboration that can facilitate innovative, science-based efforts to address the health behavior challenges afflicting our communities.
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http://dx.doi.org/10.2196/16751DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066510PMC
February 2020

Secondary Analysis of Pain Outcomes in a Large Pragmatic Randomized Trial of Buprenorphine/Naloxone Versus Methadone for Opioid Use Disorder.

J Addict Med 2020 Sep/Oct;14(5):e188-e194

New York State Psychiatric Institute, New York, NY, (MS, SL, ANCC, JS, AB, EVN); Department of Psychiatry, Columbia University Medical Center, New York, NY, (MS, SL, ANCC, JS, EVN); Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, (MP); Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine; Center of Excellence in Substance Abuse Treatment and Education VA Puget Sound Health Care System, WA (AJS).

Objective: Opioid use disorder (OUD) is associated with chronic pain. We investigated the association between medication treatments for OUD and pain in a post-hoc secondary analysis of a randomized trial of methadone versus buprenorphine/naloxone.

Methods: 1241 individuals with OUD participated in an open label, pragmatic randomized trial of methadone versus buprenorphine/naloxone in nine treatment programs licensed to dispense agonist medication for OUD between 2006 to 2009. In this post-hoc analysis, pain was dichotomized (present or not present) using responses from the Short Form-36. Logistic regression models were fit to test the effect of (1) having baseline pain on week 24 retention, (2) treatment assignment on improvement in pain among those reporting pain at baseline, and (3) pain improvement at week 4 on week 24 retention among those reporting pain at baseline.

Results: Almost half (48.2%) of the sample reported pain at baseline. Participants with baseline pain did not significantly differ in week 24 retention compared to those without baseline pain. Among those reporting pain at baseline, there was no significant difference between treatment arms in improvement of pain at week 4, but improvement in pain at week 4 was associated with significantly greater odds of being retained at week 24 (OR [95% CI] = 1.76 [1.10, 2.82], P = 0.020).

Conclusion And Relevance: In this large multisite randomized trial of medication treatments for OUD, nearly half of the participants reported pain at baseline, and improvement in pain early in treatment was associated with increased likelihood of retention in treatment.
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http://dx.doi.org/10.1097/ADM.0000000000000630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7415472PMC
June 2021

Factors Influencing Buprenorphine Prescribing among Physicians in New York State.

J Addict 2019 18;2019:7832752. Epub 2019 Dec 18.

Division of Behavioral Health Services and Policy Research, Columbia University, Department of Psychiatry, New York, NY, USA.

Background: Increasing access to buprenorphine is an important strategy for curtailing the opioid epidemic. Research is needed to understand what facilitates prescribing among waivered physicians and how to increase the willingness and capacity to prescribe. This study describes prescribing patterns in a sample of buprenorphine-waivered physicians in New York (NY) in 2016 and examines factors influencing prescribing capacity among waivered providers.

Methods: Surveys were mailed to a random sample of 300 physicians with DEA waivers to prescribe buprenorphine in NY which assessed demographics, practice characteristics, buprenorphine prescribing patterns, and barriers/facilitators to prescribing buprenorphine. Analyses include simple logistic regression to calculate the odds ratio, 95% confidence intervals, and values, respectively, to examine differences in individual predictors among physicians that were actively prescribing buprenorphine and those that were not.

Results: 91 physicians responded to the survey, and 65% indicated they were currently prescribing buprenorphine. The mean patient census among physicians waivered to prescribe to 30 patients was 9.6 (SD = 9.7, median = 5), and to 100 patients, it was 60.5 (SD = 38.9, median = 72.5). Common facilitators included access to psychosocial referrals and better reimbursement, while inadequate resources, lack of time, and prior authorizations were the most common barriers.

Conclusions: In addition to increasing the number of waivered physicians, policy-makers should provide enhanced training and implementation support for waivered physicians to start prescribing and facilitate continued and expanded prescribing among those already doing so.
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http://dx.doi.org/10.1155/2019/7832752DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6942852PMC
December 2019

A week-long outpatient induction onto XR-naltrexone in patients with opioid use disorder.

Am J Drug Alcohol Abuse 2020 05 20;46(3):289-296. Epub 2019 Dec 20.

Division on Substance Use Disorders New York State Psychiatric Institute , New York, NY, USA.

Background: Extended-release (XR) naltrexone can prevent relapse to opioid use disorder following detoxification. However, one of the barriers to initiating XR-naltrexone is the recommendation for a 7-10-day period of abstinence from opioids prior to the first dose.

Objectives: The current study evaluated the feasibility of an XR-naltrexone induction protocol that can be implemented over 1 week in the outpatient clinic.

Methods: Participants (N = 44) were seen in the clinic daily. On Day 1, after abstaining from opioids for at least 12 h, they received buprenorphine 6-8 mg. Adjunctive medications (clonidine, clonazepam, zolpidem, trazodone, and prochlorperazine) were dispensed on Days 2-5, while ascending oral doses of naltrexone were given on Days 3-5 starting with 1 mg dose. An injection of XR-naltrexone was given on Day 5, 1 h after receiving and tolerating naltrexone 24 mg.

Results: Of the 44 participants (38 males), 35 (80%) were heroin users and 9 (20%) used prescription opioids. A total of 26 participants (59%) completed the induction and received their first injection of XR-naltrexone. XR-naltrexone was initiated in 54% (19/35) of heroin users and 78% (7/9) of prescription opioid users.

Conclusion: The results support the feasibility of a week-long outpatient induction onto XR-naltrexone with ascending doses of naltrexone and standing doses of adjunctive medications. By circumventing the need for a protracted period of abstinence and mitigating the severity of withdrawal symptoms experienced during naltrexone titration, this strategy has the potential to increase patient acceptability and access to relapse prevention treatment with XR-naltrexone.
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http://dx.doi.org/10.1080/00952990.2019.1700265DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7260104PMC
May 2020

A Single Ketamine Infusion Combined With Motivational Enhancement Therapy for Alcohol Use Disorder: A Randomized Midazolam-Controlled Pilot Trial.

Am J Psychiatry 2020 02 2;177(2):125-133. Epub 2019 Dec 2.

New York State Psychiatric Institute, Columbia University Medical Center, New York (Dakwar, Levin, Hart, Nunes); the Department of Psychology, Columbia University, New York (Hart); the Division of Mental Health Data Science, New York State Psychiatric Institute, New York (Basaraba, Choi); the Department of Biostatistics, Mailman School of Public Health, Columbia University, New York (Pavlicova).

Objective: Pharmacotherapy and behavioral treatments for alcohol use disorder are limited in their effectiveness, and new treatments with innovative mechanisms would be valuable. In this pilot study, the authors tested whether a single subanesthetic infusion of ketamine administered to adults with alcohol dependence and engaged in motivational enhancement therapy affects drinking outcomes.

Methods: Participants were randomly assigned to a 52-minute intravenous administration of ketamine (0.71 mg/kg, N=17) or the active control midazolam (0.025 mg/kg, N=23), provided during the second week of a 5-week outpatient regimen of motivational enhancement therapy. Alcohol use following the infusion was assessed with timeline followback method, with abstinence confirmed by urine ethyl glucuronide testing. A longitudinal logistic mixed-effects model was used to model daily abstinence from alcohol over the 21 days after ketamine infusion.

Results: Participants (N=40) were mostly middle-aged (mean age=53 years [SD=9.8]), predominantly white (70.3%), and largely employed (71.8%) and consumed an average of five drinks per day prior to entering the study. Ketamine significantly increased the likelihood of abstinence, delayed the time to relapse, and reduced the likelihood of heavy drinking days compared with midazolam. Infusions were well tolerated, with no participants removed from the study as a result of adverse events.

Conclusions: A single ketamine infusion was found to improve measures of drinking in persons with alcohol dependence engaged in motivational enhancement therapy. These preliminary data suggest new directions in integrated pharmacotherapy-behavioral treatments for alcohol use disorder. Further research is needed to replicate these promising results in a larger sample.
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http://dx.doi.org/10.1176/appi.ajp.2019.19070684DOI Listing
February 2020