Publications by authors named "Charles E Green"

74 Publications

Posttraumatic stress symptom clusters differentially predict late positive potential to cocaine imagery cues in trauma-exposed adults with cocaine use disorder.

Drug Alcohol Depend 2021 Jul 28;227:108929. Epub 2021 Jul 28.

Department of Psychology, University of Houston, Houston, TX, United States.

Background: While studies have investigated the effects of posttraumatic stress disorder (PTSD) symptoms on substance use, information on these associations in the context of drug cue reactivity is lacking, which can provide meaningful information about risk for relapse. The current study assessed the associations between PTSD symptom clusters and reactivity to cues in trauma-exposed adults with cocaine use disorder.

Methods: We recorded electroencephalogram on 52 trauma-exposed participants (M = 51.3; SD = 7.0; 15.4 % women) diagnosed with cocaine use disorder while they viewed pleasant (i.e., erotic, romantic, sweet foods), unpleasant (i.e., mutilations, violence, accidents), neutral, and cocaine-related images. Reactivity was measured with the late positive potential (LPP), an indicator of motivational relevance. It was hypothesized that individuals with greater PTSD avoidance and negative alterations in cognition and mood (NACM) symptoms, as determined by the PTSD Checklist for DSM-5 (PCL-5), would have higher LPPs to cocaine-related images, indicating greater cue reactivity.

Results: Linear mixed modeling indicated that higher NACM symptomatology was associated with higher LPPs to cocaine cues and higher arousal/reactivity was associated with lower LPPs to cocaine cues.

Conclusions: These results highlight the potential clinical utility of the LPP in assessing drug cue reactivity in trauma-exposed adults with substance use disorder.
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http://dx.doi.org/10.1016/j.drugalcdep.2021.108929DOI Listing
July 2021

Neurophysiological and clinical effects of the NMDA receptor antagonist lanicemine (BHV-5500) in PTSD: A randomized, double-blind, placebo-controlled trial.

Depress Anxiety 2021 Jul 12. Epub 2021 Jul 12.

Menninger Department of Psychiatry & Behavioral Sciences, Mood and Anxiety Disorders Program, Baylor College of Medicine, Houston, Texas, USA.

Background: Posttraumatic stress disorder (PTSD) is associated with hyperarousal and stress reactivity, features consistent with behavioral sensitization. In this Phase 1b, parallel-arm, randomized, double-blind, placebo-controlled trial, we tested whether the selective low-trapping N-methyl-D-aspartate receptor (NMDAR) antagonist [Lanicemine (BHV-5500)] blocks expression of behavioral sensitization.

Methods: Twenty-four participants with elevated anxiety potentiated startle (APS) and moderate-to-severe PTSD symptoms received three infusions of lanicemine 1.0 mg/ml (100 mg) or matching placebo (0.9% saline) (1:1 ratio), over a 5-day period. The primary outcome was change in APS from baseline to end of third infusion. We also examined changes in EEG gamma-band oscillatory activity as measures of NMDAR target engagement and explored Clinician-Administered PTSD Scale (CAPS-5) hyperarousal scores.

Results: Lanicemine was safe and well-tolerated with no serious adverse events. Using Bayesian statistical inference, the posterior probability that lanicemine outperformed placebo on APS T-score after three infusions was 38%. However, after the first infusion, there was a 90% chance that lanicemine outperformed placebo in attenuating APS T-score by a standardized effect size more than 0.4.

Conclusion: We demonstrated successful occupancy of lanicemine on NMDAR using gamma-band EEG and effects on hyperarousal symptoms (Cohen's d = 0.75). While lanicemine strongly attenuated APS following a single infusion, differential changes from placebo after three infusions was likely obscured by habituation effects. To our knowledge, this is the first use of APS in the context of an experimental medicine trial of a NMDAR antagonist in PTSD. These findings support selective NMDAR antagonism as a viable pharmacological strategy for salient aspects of PTSD.
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http://dx.doi.org/10.1002/da.23194DOI Listing
July 2021

The effects of combination levodopa-ropinirole on cognitive improvement and treatment outcome in individuals with cocaine use disorder: A bayesian mediation analysis.

Drug Alcohol Depend 2021 Aug 31;225:108800. Epub 2021 May 31.

Faillace Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.

Background: Chronic cocaine users show impairments in cognitive processes associated with dopamine (DA) circuitry. Medications aimed at bolstering cognitive functions via DA modulation might enhance treatment outcome.

Methods: The trial used a double-blind, double-dummy, parallel-group design with four treatment arms comparing placebo (PLC) to levodopa/carbidopa 800 mg/200 mg alone (LR0), levodopa plus extended release (XR) ropinirole 2 mg (LR2) or XR ropinirole 4 mg (LR4). Adults (n = 110) with cocaine use disorder attended thrice weekly clinic visits for 10 weeks. Potential cognitive mediators assessed at week 5 consisted of measures of decision-making (Iowa Gambling Task, Risky Decision-Making Task), attention/impulsivity (Immediate Memory Task), motivation (Progressive Ratio task), and cognitive control (Cocaine Stoop task). The primary outcome measure was the treatment effectiveness score (TES) calculated as the number of cocaine-negative urines collected from weeks 6-10.

Results: Bayesian mediation examined indirect and total effects of the relationships between each active treatment (compared to PLC) and TES. Total (direct) effects were supported for LR0 and LR2, but not for LR4. Indirect effects were tested for each mediator. Notably, 22.3 % and 35.4 % of the total effects of LR0 and LR2 on TES were mediated by changes in attention/impulsivity.

Conclusions: The hypothesized mediation effect was strongest for levodopa plus 2 mg ropinirole, indicating that this DA medication combination predicted change (improvement) in attention/impulsivity, which in turn predicted change (reduction) in cocaine use. This finding provides modest support for cognitive enhancement as a target for medications to treat cocaine use disorder.
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http://dx.doi.org/10.1016/j.drugalcdep.2021.108800DOI Listing
August 2021

Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial.

Nicotine Tob Res 2021 Aug;23(10):1682-1690

Louis A. Faillace, M.D., Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston (UTHealth), McGovern Medical School, Houston, TX, USA.

Introduction: Approved pharmacological treatments for smoking cessation are modestly effective, underscoring the need for improved pharmacotherapies. Glucagon-like peptide-1 receptor (GLP-1R) agonists attenuate the rewarding effects of nicotine in preclinical studies. We examined the efficacy of extended-release exenatide, a GLP-1R agonist, combined with nicotine replacement therapy (NRT, patch) for smoking cessation, craving, and withdrawal symptoms, with post-cessation body weight as a secondary outcome.

Methods: Eighty-four prediabetic and/or overweight smokers were randomized (1 : 1) to once-weekly placebo or exenatide, 2 mg, subcutaneously. All participants received NRT (21 mg) and brief smoking cessation counseling. Seven-day point prevalence abstinence (expired CO level ≤5 ppm), craving, withdrawal, and post-cessation body weight were assessed following 6 weeks of treatment. A Bayesian approach for analyzing generalized linear models yielded posterior probabilities (PP) to quantify the evidence favoring hypothesized effects of treatment on the study outcomes.

Results: Exenatide increased the risk for smoking abstinence compared to placebo (46.3% and 26.8%, respectively), (risk ratio [RR] = 1.70; 95% credible interval = [0.96, 3.27]; PP = 96.5%). Exenatide reduced end-of-treatment craving in the overall sample and withdrawal among abstainers. Post-cessation body weight was 5.6 pounds lower in the exenatide group compared to placebo (PP = 97.4%). Adverse events were reported in 9.5% and 2.3% of participants in the exenatide and placebo groups, respectively.

Conclusions: Exenatide, in combination with the NRT improved smoking abstinence, reduced craving and withdrawal symptoms, and decreased weight gain among abstainers. Findings suggest that the GLP-1R agonist strategy is worthy of further research in larger, longer duration studies.

Implications: Despite considerable progress in tobacco control, cigarette smoking remains the leading cause of preventable disease, disability, and death. In this pilot study, we showed that extended-release exenatide, a glucagon-like peptide-1 receptor agonist, added to the nicotine patch, improved abstinence and mitigated post-cessation body weight gain compared to patch alone. Further research is needed to confirm these initial positive results.
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http://dx.doi.org/10.1093/ntr/ntab066DOI Listing
August 2021

Electrophysiological responses to emotional and cocaine cues reveal individual neuroaffective profiles in cocaine users.

Exp Clin Psychopharmacol 2021 Feb 25. Epub 2021 Feb 25.

Department of Behavioral Science.

Smokers with stronger neuroaffective responses to drug-related cues compared to nondrug-related pleasant images (C > P) are more vulnerable to compulsive smoking than individuals with the opposite brain reactivity profile (P > C). However, it is unknown if these neurobehavioral profiles exist in individuals abusing other drugs. We tested whether individuals with cocaine use disorder (CUD) show similar neuroaffective profiles to smokers. We also monitored eye movements to assess attentional bias toward cues and we further performed exploratory analyses on demographics, personality, and drug use between profiles. Participants with CUD ( = 43) viewed pleasant, unpleasant, cocaine, and neutral images while we recorded electroencephalogram. For each picture category, we computed the amplitude of the late positive potential (LPP), an event-related potential component that reflects motivational relevance. k-means clustering classified participants based on their LPP responses. In line with what has been observed in smokers, clustering participants using LPP responses revealed the presence of two groups: one with larger LPPs to pleasant images compared to cocaine images (P > C) and one group with larger LPPs to cocaine images compared to pleasant images (C > P). Individuals with the C > P reactivity profile also had higher attentional bias toward drug cues. The two groups did not differ on demographic and drug use characteristics, however individuals with the C > P profile reported lower distress tolerance, higher anhedonia, and higher posttraumatic stress symptoms compared to the P > C group. This is the first study to report the presence of these neuroaffective profiles in individuals with CUD, indicating that this pattern may cut across addiction populations. (PsycInfo Database Record (c) 2021 APA, all rights reserved).
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http://dx.doi.org/10.1037/pha0000450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8406778PMC
February 2021

Utility of a brief assessment of opioid demand among post-discharge trauma care patients.

Exp Clin Psychopharmacol 2020 Jul 16. Epub 2020 Jul 16.

Faillace Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center McGovern Medical School.

Opioid misuse and opioid-related death are a growing public health concern. One population of interest is recent trauma and/or surgery patients, who are at increased risk of developing an opioid use disorder (OUD). Although a variety of assessments have been developed to screen for risk of opioid misuse, each has limitations and prediction needs improvement. One promising measure is drug demand, a behavioral economic measure assessing drug consumption at different price points. In the current proposal, we assessed the utility of a brief assessment of opioid demand. Demand and various pain-related self-report measures among trauma-surgery patients ( = 103) were assessed at 4 weeks post-discharge. Opioid demand was significantly associated with self-report measures of pain and amount of morphine milligram equivalents (MME) received during the hospital stay. The current result support the utility of the opioid demand as an adjunctive and complementary measure to assess risk of opioid misuse. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/pha0000412DOI Listing
July 2020

Risk of Depression in the Adolescent and Adult Offspring of Mothers With Perinatal Depression: A Systematic Review and Meta-analysis.

JAMA Netw Open 2020 06 1;3(6):e208783. Epub 2020 Jun 1.

Faillace Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston.

Importance: Maternal depression during pregnancy is associated with emotional and behavioral difficulties of offspring during childhood that can increase the risk of depression in adolescence and adulthood.

Objective: To investigate the association between perinatal maternal depression and an increased long-term risk of depression in their adolescent and adult offspring.

Data Sources: A systematic search of the electronic databases of PubMed and PsycINFO was conducted from May 2019 to June 2019.

Study Selection: A total of 6309 articles were identified, of which 88 articles were extracted for full-text review by 2 reviewers. Only articles reporting data from prospective longitudinal studies that assessed maternal depression during antenatal and/or postnatal periods and resulting offspring 12 years or older with measures of established psychometric properties were included. Exclusion criteria consisted of all other study designs, mothers with other medical and psychiatric comorbidities, and offspring younger than 12 years.

Data Extraction And Synthesis: Data were extracted by 2 independent reviewers, and discrepancies were mediated by an expert third reviewer. Meta-analysis was performed using Bayesian statistical inference and reported using Meta-analysis of Observational Studies in Epidemiology (MOOSE) guideline. The association of depression timing with the sex of offspring was explored using metaregression.

Main Outcomes And Measures: Offspring depression was evaluated using standardized depression scales or clinical interviews.

Results: Six studies with a total of 15 584 mother-child dyads were included in the meta-analysis, which found the offspring of mothers who experienced perinatal depression to have increased odds of depression (odds ratio [OR], 1.70; 95% credible interval [CrI], 1.60-2.65; posterior probability [PP] [OR >1], 98.6%). Although metaregression found no evidence for an overall association between perinatal depression timing and offspring depression (antenatal vs postnatal, PP [OR >1] = 53.8%), subgroup analyses showed slightly higher pooled odds for the antenatal studies (OR, 1.78; 95% CrI, 0.93-3.33; PP [OR >1] = 96.2%) than for the postnatal studies (OR, 1.66; 95% CrI, 0.65-3.84; PP [OR >1] = 88.0%). Female adolescent offspring recorded higher rates of depression in metaregression analyses, such that a 1% increase in the percentage of female (relative to male) offspring was associated with a 6% increase in the odds of offspring depression (OR, 1.06; 95% CrI, 0.99-1.14; τ2 = 0.31).

Conclusions And Relevance: In this study, maternal perinatal depression, especially antenatal depression, was associated with the risk of depression in adolescence and adulthood. More research into the mechanisms of depression risk transmission and assessments of postinterventional risk reduction could aid in the development of future strategies to tackle depressive disorders in pregnancy.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.8783DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327545PMC
June 2020

Opioid exposure after injury in United States trauma centers: A prospective, multicenter observational study.

J Trauma Acute Care Surg 2020 06;88(6):816-824

From the Department of Surgery and the Center for Translational Injury Research (J.A.H., V.T.T.T., C.E.G., C.E.W., L.S.K.), McGovern Medical School, University of Texas, Houston, Texas; Department of Surgery (L.A., J.M.), University of Texas Health Tyler, Tyler, Texas; Department of Surgery (J.J.R., J.N.B.), St. Joseph's Hospital and Medical Center, Phoenix, Arizona; Department of Surgery (P.B.M., B.B.P.-J., B.L.Z.), Indiana University, Indianapolis, Indiana; Department of Surgery (J.R.T., K.WS.), University of Arkansas for Medical Sciences, Little Rock, Arkansas; and Department of Surgery (C.D., T.J.S.), University of Colorado Health Memorial Hospital Central, Colorado Springs, Colorado.

Background: Efforts to reduce opioid use in trauma patients are currently hampered by an incomplete understanding of the baseline opioid exposure and variation in United States. The purpose of this project was to obtain a global estimate of opioid exposure following injury and to quantify the variability of opioid exposure between and within United States trauma centers.

Study Design: Prospective observational study was performed to calculate opioid exposure by converting all sources of opioids to oral morphine milligram equivalents (MMEs). To estimate variation, an intraclass correlation was calculated from a multilevel generalized linear model adjusting for the a priori selected variables Injury Severity Score and prior opioid use.

Results: The centers enrolled 1,731 patients. The median opioid exposure among all sites was 45 MMEs per day, equivalent to 30 mg of oxycodone or 45 mg of hydrocodone per day. Variation in opioid exposure was identified both between and within trauma centers with the vast majority of variation (93%) occurring within trauma centers. Opioid exposure increased with injury severity, in male patients, and patients suffering penetrating trauma.

Conclusion: The overall median opioid exposure was 45 MMEs per day. Despite significant differences in opioid exposure between trauma centers, the majority of variation was actually within centers. This suggests that efforts to minimize opioid exposure after injury should focus within trauma centers and not on high-level efforts to affect all trauma centers.

Level Of Evidence: Epidemiological, level III.
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http://dx.doi.org/10.1097/TA.0000000000002679DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802946PMC
June 2020

Socioecological indicators of senior financial exploitation: an application of data science to 8,800 substantiated mistreatment cases.

J Elder Abuse Negl 2020 Mar-May;32(2):105-120. Epub 2020 Mar 10.

UTHealth McGovern Medical School, Division of Geriatric and Palliative Medicine, Houston, Texas, USA.

Senior financial exploitation (FE) is prevalent and harmful. Its often insidious nature and co-occurrence with other forms of mistreatment make detection and substantiation challenging. A secondary data analysis of N = 8,800 Adult Protective Services substantiated senior mistreatment cases, using machine learning algorithms, was conducted to determine when pure FE versus hybrid FE was occurring. FE represented N = 2514 (29%) of the cases with 78% being pure FE. Victim suicidal ideation and threatening behaviors, injuries, drug paraphernalia, contentious relationships, caregiver stress, and burnout and victims needing assistance were most important for differentiating FE vs non-FE-related mistreatment. The inability to afford housing, medications, food, and medical care as well as victims suffering from intellectual disability disorder(s) predicted hybrid FE. This study distinguishes socioecological factors strongly associated with the presence of FE during protective service investigations. These findings support existing and new indicators of FE and could inform protective service investigation practices.
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http://dx.doi.org/10.1080/08946566.2020.1737615DOI Listing
December 2020

Assessment of an Updated Neonatal Research Network Extremely Preterm Birth Outcome Model in the Vermont Oxford Network.

JAMA Pediatr 2020 05 4;174(5):e196294. Epub 2020 May 4.

Office of Research, George Mason University College of Health and Human Services, Fairfax, Virginia.

Importance: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN) extremely preterm birth outcome model is widely used for prognostication by practitioners caring for families expecting extremely preterm birth. The model provides information on mean outcomes from 1998 to 2003 and does not account for substantial variation in outcomes among US hospitals.

Objective: To update and validate the NRN extremely preterm birth outcome model for most extremely preterm infants in the United States.

Design, Setting, And Participants: This prognostic study included 3 observational cohorts from January 1, 2006, to December 31, 2016, at 19 US centers in the NRN (derivation cohort) and 637 US centers in Vermont Oxford Network (VON) (validation cohorts). Actively treated infants born at 22 weeks' 0 days' to 25 weeks' 6 days' gestation and weighing 401 to 1000 g, including 4176 in the NRN for 2006 to 2012, 45 179 in VON for 2006 to 2012, and 25 969 in VON for 2013 to 2016, were studied. VON cohorts comprised more than 85% of eligible US births. Data analysis was performed from May 1, 2017, to March 31, 2019.

Exposures: Predictive variables used in the original model, including infant sex, birth weight, plurality, gestational age at birth, and exposure to antenatal corticosteroids.

Main Outcomes And Measures: The main outcome was death before discharge. Secondary outcomes included neurodevelopmental impairment at 18 to 26 months' corrected age and measures of hospital resource use (days of hospitalization and ventilator use).

Results: Among 4176 actively treated infants in the NRN cohort (48% female; mean [SD] gestational age, 24.2 [0.8] weeks), survival was 63% vs 62% among 3702 infants in the era of the original model (47% female; mean [SD] gestational age, 24.2 [0.8] weeks). In the concurrent (2006-2012) VON cohort, survival was 66% among 45 179 actively treated infants (47% female; mean [SD] gestational age, 24.1 [0.8] weeks) and 70% among 25 969 infants from 2013 to 2016 (48% female; mean [SD] gestational age, 24.1 [0.8] weeks). Model C statistics were 0.74 in the 2006-2012 validation cohort and 0.73 in the 2013-2016 validation cohort. With the use of decision curve analysis to compare the model with a gestational age-only approach to prognostication, the updated model showed a predictive advantage. The birth hospital contributed equally as much to prediction of survival as gestational age (20%) but less than the other factors combined (60%).

Conclusions And Relevance: An updated model using well-known factors to predict survival for extremely preterm infants performed moderately well when applied to large US cohorts. Because survival rates change over time, the model requires periodic updating. The hospital of birth contributed substantially to outcome prediction.
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http://dx.doi.org/10.1001/jamapediatrics.2019.6294DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7052789PMC
May 2020

Elevated Neutrophil to Lymphocyte Ratio in Older Adults with Cocaine Use Disorder as a Marker of Chronic Inflammation.

Clin Psychopharmacol Neurosci 2020 Feb;18(1):32-40

Faillace Department of Psychiatry and Behavioral Sciences, TX, USA.

Objective: The neutrophil to lymphocyte ratio (NLR) is a non-specific, easy-to-obtain marker of inflammation associated with morbidity and mortality in systemic, psychiatric, and age-related inflammatory conditions. Given the growing trend of substance use disorder (SUD) in older adults, and the relationship between inflammation and SUD elevated NLR may serve as a useful inflammatory biomarker of the combined burden of aging and SUD. The present study focused on cocaine use disorder (CUD) to examine if cocaine adds further inflammatory burden among older adults, by comparing NLR values between older adults with CUD and a non-cocaine using, aged-matched, nationally representative sample.

Methods: The dataset included 107 (86% male) participants (aged 50-65 years) with cocaine use disorder. NLR was derived from complete blood count tests by dividing the absolute value of peripheral neutrophil concentration by lymphocyte concentration. For comparison, we extracted data from age-matched adults without CUD using the National Health and Nutrition Examination Survey. Individuals with immunocompromising conditions were excluded (e.g., rheumatoid arthritis and sexually transmitted infections such as HIV). A doubly-robust inverse probability-weighted regression adjustment (IPWRA) propensity score method was used to estimate group differences on NLR while controlling for potential confounding variables (age, gender, race, income, nicotine, marijuana and alcohol use).

Results: The IPWRA model revealed that the CUD sample had significantly elevated NLR in comparison to non-cocaine users, with a moderate effect size (β weight = 0.67).

Conclusion: Although non-specific, NLR represents a readily obtainable inflammatory marker for SUD research. CUD may add further inflammatory burden to aging cocaine users.
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http://dx.doi.org/10.9758/cpn.2020.18.1.32DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006975PMC
February 2020

A Proof-of-Mechanism Study to Test Effects of the NMDA Receptor Antagonist Lanicemine on Behavioral Sensitization in Individuals With Symptoms of PTSD.

Front Psychiatry 2019 13;10:846. Epub 2019 Dec 13.

Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.

Individuals with post-traumatic stress disorder (PTSD) have a heightened sensitivity to subsequent stressors, addictive drugs, and symptom recurrence, a form of behavioral sensitization. N-methyl-D-aspartate receptors (NMDARs) are involved in the establishment and activation of sensitized behavior. We describe a protocol of a randomized placebo-controlled Phase 1b proof-of-mechanism trial to examine target engagement, safety, tolerability, and possible efficacy of the NMDAR antagonist lanicemine in individuals with symptoms of PTSD (Clinician Administered PTSD Scale [CAPS-5] score ≥ 25) and evidence of behavioral sensitization measured as enhanced anxiety-potentiated startle (APS; T-score ≥ 2.8). Subjects (n = 24; age range 21-65) receive three 60-min intravenous infusions of placebo or 100 mg lanicemine over 5 non-consecutive days. Primary endpoint is change in APS from pre-treatment baseline to after the third infusion. NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating. Change in CAPS-5 scores is an exploratory clinical endpoint. Bayesian statistical methods will evaluate endpoints to determine suitability of this agent for further study. In contrast to traditional early-phase trials that use symptom severity to track treatment efficacy, this study tracks engagement of the study drug on expression of behavioral sensitization, a functional mechanism likely to cut across disorders. This experimental therapeutics design is consistent with recent NIMH-industry collaborative studies, and could serve as a template for testing novel pharmacological agents in psychiatry. www.ClinicalTrials.gov, identifier NCT03166501.
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http://dx.doi.org/10.3389/fpsyt.2019.00846DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6923195PMC
December 2019

Self-efficacy and Physical Activity in Overweight and Obese Adults Participating in a Worksite Weight Loss Intervention: Multistate Modeling of Wearable Device Data.

Cancer Epidemiol Biomarkers Prev 2020 04 23;29(4):769-776. Epub 2019 Dec 23.

Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Background: Physical activity is associated with a reduced risk of numerous types of cancer and plays an important role in maintaining a healthy weight. Wearable physical activity trackers may supplement behavioral intervention and enable researchers to study how determinants like self-efficacy predict physical activity patterns over time.

Methods: We used multistate models to evaluate how self-efficacy predicted physical activity states among overweight and obese individuals participating in a 26-week weight loss program ( = 96). We specified five states to capture physical activity patterns: (i) active (i.e., meeting recommendations for 2 weeks), (ii) insufficiently active, (iii) nonvalid wear, (iv) favorable transition (i.e., improvement in physical activity over 2 weeks), and (v) unfavorable transition. We calculated HRs of transition probabilities by self-efficacy, body mass index, age, and time.

Results: The average prevalence of individuals in the active, insufficiently active, and nonvalid wear states was 13%, 44%, and 16%, respectively. Low self-efficacy negatively predicted entering an active state [HR, 0.51; 95% confidence interval (CI), 0.29-0.88]. Obesity negatively predicted making a favorable transition out of an insufficiently active state (HR, 0.61; 95% CI, 0.40-0.91). Older participants were less likely to transition to the nonvalid wear state (HR, 0.53; 95% CI, 0.30-0.93). Device nonwear increased in the second half of the intervention (HR, 1.73; 95% CI, 1.07-2.81).

Conclusions: Self-efficacy is an important predictor for clinically relevant physical activity change in overweight and obese individuals. Multistate modeling is useful for analyzing longitudinal physical activity data.

Impact: Multistate modeling can be used for statistical inference of covariates and allow for explicit modeling of nonvalid wear.
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http://dx.doi.org/10.1158/1055-9965.EPI-19-0907DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7125025PMC
April 2020

Bayesian adaptive randomization trial of intravenous ketamine for veterans with late-life, treatment-resistant depression.

Contemp Clin Trials Commun 2019 12 21;16:100432. Epub 2019 Aug 21.

Michael E. DeBakey VA Medical Center, Houston, TX, USA.

More than eleven million U.S. Veterans are at least 65 years of age, an age group of which almost 20% suffers from clinically significant depressive symptoms. Available pharmacological treatments are suboptimal for patients, including veterans, with late-life depression. Ketamine has emerged as a potentially promising rapid-acting therapy for treatment-resistant depression (TRD). However, few studies have examined the safety, tolerability and efficacy of ketamine therapy for older adults with late-life TRD (LL-TRD). This study uses an adaptive randomization design to test the safety, tolerability, efficacy, and durability of three distinct, single sub-anesthetic doses of intravenous (IV) ketamine versus a single dose of active placebo (midazolam) in older depressed veterans. As the study progresses, Bayesian adaptive randomization recalibrates randomization ratios to allocate more participants to conditions demonstrating greater promise and fewer participants to conditions with less promise. Secondary analyses explore clinical and biological moderating and mediating factors of rapid treatment response. Results are expected to inform both the viability of ketamine treatment and optimal dosing strategies for patients with LL-TRD.
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http://dx.doi.org/10.1016/j.conctc.2019.100432DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6727003PMC
December 2019

Preliminary examination of the orexin system on relapse-related factors in cocaine use disorder.

Brain Res 2020 03 30;1731:146359. Epub 2019 Jul 30.

Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA; MD Anderson - UTHealth Graduate School of Biomedical Sciences, Program in Neuroscience, University of Texas Health Science Center at Houston, Houston, TX, USA.

Rationale: Current evidence and literature reviews provide a strong justification for examining the orexin receptor (OXR) system as a therapeutic target in substance use disorders, including cocaine and other psychostimulants.

Objectives: In this preliminary, proof-of-concept examination of orexin modulation in humans with cocaine use disorder, we measured changes in domains tied to relapse: stress, sleep, cue reactivity, and inhibitory control. Additionally, mood symptoms (anxiety, depression), medication compliance, and side effects were assessed.

Methods: Twenty non-treatment seeking subjects with cocaine use disorder (CUD) received either the OXR / OXR antagonist suvorexant PO or placebo at 10 PM daily for two weeks (10 mg week 1, 20 mg week 2). Using psychometrics, smart-watch actigraphy, a cold-pressor stress challenge, and eye-tracking technology, the following domains were examined: sleep, stress/anxiety, cue-reactivity (attentional bias, craving), and inhibitory control. Psychometric data were collected every M/W/F (7 time points). Laboratory data were collected weekly (3 time points).

Results: Bayesian and frequentist generalized linear models were employed in parallel to examine the effects of suvorexant compared to placebo, with a Bayesian posterior probability threshold >80% as evidence of a signal for suvorexant. Notable results favoring suvorexant over placebo included fewer total anti-saccade errors, improved sleep actigraphy (sleep/awake periods), pre/post cold-pressor change in heart rate and salivary cortisol (all posterior probabilities >94%), and craving (posterior probability >87%).

Conclusions: Initial but restricted evidence is provided supporting the orexin system as a modulator of relapse-related processes in cocaine use disorder. Baseline differences in the main outcome variables were not experimentally controlled and differences in craving were observed at baseline. This, in combination with a limited sample size, constrain the nature of the project. The results may serve to inform more comprehensive future research.
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http://dx.doi.org/10.1016/j.brainres.2019.146359DOI Listing
March 2020

Predicting HCV Incidence in Latinos with High-Risk Substance Use: A Data Science Approach.

Soc Work Public Health 2019 2;34(7):606-615. Epub 2019 Aug 2.

Department of Family and Community Medicine, McGovern Medical School at UTHealth , Houston , Texas , USA.

Hepatitis C virus (HCV) in the U.S. has tripled in the prior five years, and injecting drug use is the primary risk for HCV, with up to 90% of older and former people who inject drugs (PWIDs) testing positive. Laboratory testing of HCV for any PWIDs is the gold standard, however many PWIDs lack access to health treatment or services. Identifying risks of HCV via a data science approach would aid community health workers (CHW) to rapidly link those most at risk of infection with treatment. This study employed a data-science approach to determine the strongest risk factors of HCV in a sample of Mexican-Americans WIDs n = 221 (96 negative/125 positive). Data included 238 demographic and psychosocial predictors. A Random Forest machine learning algorithm demonstrated significant prediction improvement over baseline no information rate comparison. Strongest risks for positive HCV included sharing drug-use equipment and younger age at first heroin use; receiving drug-education during incarceration was protective. A ROC curve fit to the prediction yielded an area under the curve of 0.77. Predictive variables of HCV in the present analysis can be obtained via screening by CHW. Identification of patients most at risk of HCV within community settings can maximize treatment utilization.
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http://dx.doi.org/10.1080/19371918.2019.1635948DOI Listing
June 2020

Change in physical activity and quality of life in endometrial cancer survivors receiving a physical activity intervention.

Health Qual Life Outcomes 2019 May 27;17(1):91. Epub 2019 May 27.

Center for Energy Balance, Department of Behavioral Science, MD Anderson Cancer Center, Cancer Prevention Building, Unit 1330, 1155 Pressler St, Houston, TX, 77030, USA.

Background: Endometrial cancer survivors are at an increased risk of poor quality of life outcomes. Physical activity is positively associated with general quality of life in this population, however, little is known about how changes in physical activity may be associated with changes in specific aspects of quality of life. The aim of this secondary data analysis was to explore the relationships between change in physical activity and change in physical, mental, social, and other aspects of quality of life in endometrial cancer survivors receiving a physical activity intervention.

Methods: Endometrial cancer survivors (N = 100) participated in a telephone-based physical activity intervention for six months. At baseline and post-intervention we measured physical activity via accelerometry and ecological momentary assessment, and quality of life via the Short Form Health Survey (SF-36), the Quality of Life of Adult Cancer Survivors instrument, the Brief Symptom Inventory, the Pittsburgh Sleep Quality Index, and the Perceived Stress Scale. We conducted structural equation modeling path analyses to investigate how physical activity post-intervention was associated with the quality of life measures' subscales post-intervention, adjusting for baseline levels and potentially confounding covariates.

Results: Increasing physical activity was positively associated with improvements in general health (p = .044), role limitation due to physical health (p = .005), pain (p = .041), and somatic distress (p = .023). There was no evidence to indicate that change in physical activity was associated with change in other aspects of quality of life.

Conclusions: Endometrial cancer survivors are at higher risk for suffering from challenges to physical quality of life, and findings from this study suggest that increasing physical activity may alleviate some of these problems. Further research is needed to determine whether other aspects of quality of life are linked to change in physical activity.

Trial Registration: Trial registration number: NCT00501761 Name of registry: clinicaltrials.gov Date of registration: July 16, 2007. Date of enrollment: June 16, 2005.
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http://dx.doi.org/10.1186/s12955-019-1154-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537149PMC
May 2019

The Late Positive Potentials Evoked by Cigarette-Related and Emotional Images Show no Gender Differences in Smokers.

Sci Rep 2019 03 1;9(1):3240. Epub 2019 Mar 1.

MD Anderson Cancer Center, University of Texas, Houston, TX, USA.

When trying to quit, women are less likely than men to achieve long-term smoking abstinence. Identifying the neuropsychological mechanisms underlying women's higher relapse vulnerability will help clinicians to develop effective tailored smoking cessation interventions. Here we used event-related potentials (ERPs), a direct measure of brain activity, to evaluate the extent to which neurophysiological responses to cigarette-related and other emotional stimuli differ between female and male smokers. Both women and men showed similar patterns of brain reactivity across all picture categories; pleasant and unpleasant images prompted larger Late Positive Potentials (LPPs, a robust measure of motivational relevance) than neutral images in both groups, and cigarette-related images prompted lower LPPs than high arousing emotional images in both groups. Unlike previous studies, there were no differences between male and female smokers with regard to LPP responses to cigarette-related images. This suggests that the LPP may not be ideally suited to discriminate neurophysiological gender differences or that there are simply no gender differences in the neurophysiological responses to cigarette-related stimuli. We collected ERPs from 222 non-nicotine-deprived smokers (101 women) while they watched a slideshow that included high and low emotionally arousing pleasant and unpleasant pictures, cigarette-related, and neutral pictures. We used the mean amplitude of the LPP to assess the affective significance that participants attributed to these pictures.
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http://dx.doi.org/10.1038/s41598-019-39954-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6397300PMC
March 2019

Using Machine Learning to Identify Change in Surgical Decision Making in Current Use of Damage Control Laparotomy.

J Am Coll Surg 2019 03 9;228(3):255-264. Epub 2019 Jan 9.

Department of Surgery, University of Texas McGovern Medical School, Houston, TX; Center for Clinical Research and Evidence Based Medicine, University of Texas McGovern Medical School, Houston, TX.

Background: In an earlier study, we reported the successful reduction in the use of damage control laparotomy (DCL); however, no change in the relative frequencies of specific indications was observed. In this study, we aimed to use machine learning to help identify the changes in surgical decision making that occurred.

Study Design: Adult patients undergoing emergent trauma laparotomy were included: pre-quality improvement (QI): January 1, 2011 to October 31, 2013 and post-QI: November 1, 2013 to June 30, 2016. Using 72 variables before or during emergent laparotomy, random forest algorithms predicting DCL before and after a QI intervention were created. The main end point of the algorithms was the strength of individual factor significance in predicting the use of DCL, calculated by determining the mean decrease in accuracy (MDA) in the model if that variable was removed.

Results: In the pre-QI group, 24 of 72 factors significantly predicted DCL, the strongest being bowel resection (mean MDA 16) and operating room RBC transfusions (mean MDA 15). The remaining variables were spread along the continuum of care from injury to emergent laparotomy end. In the post-QI group, 12 of 72 factors significantly predicted DCL, the strongest being last operating room lactate (mean MDA 12) and operating room RBC transfusions (mean MDA 14). In addition to having 12 fewer significant factors predictive of DCL, the predictive factors in the post-QI group were mainly intraoperative factors.

Conclusions: A machine learning analysis provided novel insights into the changes in decision making achieved by a successful QI intervention and should be considered an adjunct to understanding successful pre- and post-intervention QI studies. The analysis suggested a shift toward using mostly intraoperative factors to determine the use of DCL.
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http://dx.doi.org/10.1016/j.jamcollsurg.2018.12.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6391184PMC
March 2019

Using a data science approach to predict cocaine use frequency from depressive symptoms.

Drug Alcohol Depend 2019 01 15;194:310-317. Epub 2018 Nov 15.

Department of Psychiatry and Behavioral Sciences, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), 1941 East Road, Houston, TX, United States; Department of Psychology, University of Illinois at Chicago, Behavioral Sciences Building, 1007 W. Harrison St., Chicago, IL, United States. Electronic address:

Background: Depressive symptoms may contribute to cocaine use. However, tests of the relationship between depression and severity of cocaine use have produced mixed results, possibly due to heterogeneity in individual symptoms of depression. Our goal was to establish which symptoms of depression are most strongly related to frequency of cocaine use (one aspect of severity) in a large sample of current cocaine users. We utilized generalized additive modeling to provide data-driven exploration of the relationships between depressive symptoms and cocaine use, including examination of non-linearity. We hypothesized that symptoms related to anhedonia would demonstrate the strongest relationship to cocaine use.

Method: 772 individuals screened for cocaine use disorder treatment studies. To measure depressive symptoms, we used the items of the Beck Depression Inventory, 2nd Edition. Cocaine use frequency was measured as proportion of self-reported days of cocaine use over the last 30 days using the Addiction Severity Index.

Results: Models identified 18 significant predictors of past-30-day cocaine use. The strongest predictors were Crying, Pessimism, Changes in Appetite, Indecisiveness, and Loss of Interest. Noteworthy effect sizes were found for specific response options on Suicidal Thoughts, Worthlessness, Agitation, Concentration Difficulty, Tiredness, and Self Dislike items.

Conclusions: The strongest predictors did not conform to previously hypothesized "subtypes" of depression. Non-linear relationships between items and use were typical, suggesting BDI-II items may not be monotonically increasing ordinal measures with respect to predicting cocaine use. Qualitative analysis of strongly predictive response options suggested emotional volatility and disregard for the future as important predictors of use.
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http://dx.doi.org/10.1016/j.drugalcdep.2018.10.029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6317336PMC
January 2019

Resting Heart Rate Variability: Exploring Associations With Symptom Severity in Adults With Substance Use Disorders and Posttraumatic Stress.

J Dual Diagn 2019 Jan-Mar;15(1):2-7. Epub 2018 Nov 11.

a Department of Psychology , University of Houston , Houston , Texas , USA.

Substance use disorders and posttraumatic stress symptoms are commonly comorbid. Previous studies have established that those with substance use disorders or posttraumatic stress disorder (PTSD) have lower high frequency-heart rate variability (HF-HRV) compared to controls, suggesting that low HF-HRV may be a biomarker of a common physiological mechanism underlying both disorders. We evaluated HF-HRV as a potential biomarker of a common underlying process by testing whether lower HF-HRV related to greater severity of substance use and PTSD symptoms in individuals with both substance use disorders and at least four symptoms of PTSD. HF-HRV was measured in 49 adults with substance use disorders and at least four symptoms of PTSD. We performed a series of regressions controlling for age to test whether low HF-HRV was associated with greater substance use disorder and PTSD symptom severity. Substance use disorder symptoms were measured by the Addiction Severity Index and PTSD symptoms were measured by the Clinician-Administered PTSD Scale and the PTSD Checklist. After controlling for age, low resting HF-HRV was significantly associated with drug and alcohol symptom severity but not PTSD symptom severity. HF-HRV may be more sensitive to the severity of drug and alcohol use rather than PTSD. Findings may suggest that in PTSD populations, HF-HRV may primarily index comorbid substance use disorder symptoms. HF-HRV could serve as an objective measure of substance use severity and should be further investigated as a predictor of outcomes in treatment for substance use disorders.
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http://dx.doi.org/10.1080/15504263.2018.1526431DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6511322PMC
March 2020

Multi-modal Analgesic Strategies for Trauma (MAST): protocol for a pragmatic randomized trial.

Trauma Surg Acute Care Open 2018 19;3(1):e000192. Epub 2018 Aug 19.

Department of Surgery, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.

Background: Pain management after injury is critically important for functional recovery. Although opioids have been a mainstay for treatment of pain, they are associated with adverse events and may contribute to long-term use or abuse. Opioid-minimizing multimodal pain regimens have the potential to reduce exposure to opioids without compromising pain control. This article details an ongoing clinical trial comparing two pill-based, opioid-minimizing, multimodal pain strategies.

Methods: This is a single-center, parallel-group, randomized, controlled comparative effectiveness trial comparing two multimodal pain regimens in adult trauma patients. All patients 16 years and older admitted to the Red Duke Trauma Institute are eligible unless they are pregnant, a prisoner, under observation status, or a non-acute trauma patient. At admission to the trauma service, patients are enrolled and randomized to one of two multimodal pain regimens. The primary outcome is opioid use, measured by morphine milligram equivalents per patient per day. The secondary outcomes include pain scores, ventilator days, hospital and intensive care unit lengths of stay, occurrence of opioid-related complications, hospital and pharmacy costs, and incidence of hospital discharge with opioid prescription. Outcomes will be compared using Bayesian methods.

Discussion: This trial will determine the effectiveness of two multimodal pain treatment strategies on reducing in-hospital opioid exposure in adult trauma patients. Furthermore, it will compare the two strategies on pain control and patient safety. Knowledge gained in this study can improve quality of care at this hospital and other trauma centers regardless of which medication regimen proves superior.
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http://dx.doi.org/10.1136/tsaco-2018-000192DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6109800PMC
August 2018

Randomized Quality Improvement Trial of Opting-In Versus Opting-Out to Increase Influenza Vaccination Rates during Pregnancy.

AJP Rep 2018 Jul 28;8(3):e161-e167. Epub 2018 Aug 28.

Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), Houston, Texas.

 Despite strong recommendations, only 40.6% of pregnant women attending two prenatal clinics were vaccinated against influenza during the 2009 pandemic. We tested whether an opting-out approach would improve vaccine uptake.  We conducted a randomized quality improvement (QI) trial to compare opting-out with conventional opting-in consent for influenza immunization. Women age ≥ 18 years attending the University of Texas Health Science Center at Houston (UTHealth) or UT-Medical Branch (UTMB) prenatal clinics during the 2010-2011 influenza season, were eligible.  We enrolled 280 women (140 UTHealth, 140 UTMB). Both groups had similar mean age (26.0 ± 5.5 years), mean gestational age (19.4 ± 9.5 weeks), and percent with underlying health conditions (20.7%). Vaccination rates with opting-in and opting-out were similar among all (83 vs. 84%), UTHealth (87 vs. 93%), and UTMB patients (79 vs.76%) (  > 0.05). In subsamples of patients assessed, consent strategy did not significantly affect maternal recall of information provided.  While prenatal influenza vaccination uptake doubled from the 2009-2010 influenza season, opting-out did not perform better than opting-in, a conclusion opposite that we would have reached had this been a nonconcurrent trial. Vaccination rates dropped posttrial; hence, continued research is needed to increase the prenatal influenza immunizations.
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http://dx.doi.org/10.1055/s-0038-1668566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6113052PMC
July 2018

Patterns of Tobacco Product Use and Correlates Among Adults in the Population Assessment of Tobacco and Health (PATH) Study: A Latent Class Analysis.

Nicotine Tob Res 2018 08;20(suppl_1):S81-S87

Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX.

Introduction: As the tobacco industry and market evolves, there is a growing need to understand the patterns of use of tobacco products and how they relate to demographics, dependency, withdrawal, and quit behavior.

Methods: We analyzed data from wave 1 of the PATH Study consisting of 14856 individuals. Current users were defined as consuming at least 1 of 10 tobacco products. We performed a latent class analysis (LCA) to identify patterns of tobacco use. We used multinomial regression analysis to explore the association between these patterns with covariates representing socioeconomic status dependence/addiction, past quit attempts, and withdrawal severity.

Results: We identified four groups of current tobacco users with distinct profiles: (1) 61% of the sample were identified as cigarette-only users; (2) 9% were smokeless tobacco users; (3) 17% of the sample were characterized by being current users of all types of combustible tobacco including cigars, cigarillos, filtered cigars, and smoking a pipe (4) finally, 13% were e-cig and hookah users. All classes also shared a varying frequency of cigarette use. Exclusive cigarette users were more likely to be older and female, and experienced higher dependency and withdrawal. Users of e-cigs and hookah were the younger, most educated of all four subgroups, and presented the lowest dependency and withdrawal among the four groups.

Conclusions: FDA policy makers may want to discourage the use of tobacco products associated with higher tobacco dependency, and products that may contribute to experiencing higher levels of withdrawal symptoms by the user when trying to quit.

Implications: We identified four patterns of tobacco product use that are significantly related to demographic characteristics, dependency, and withdrawal. Policies should target users more likely to use tobacco products that increase dependency and withdrawal, making quitting more difficult.
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http://dx.doi.org/10.1093/ntr/nty025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6093445PMC
August 2018

A data science approach to predicting patient aggressive events in a psychiatric hospital.

Psychiatry Res 2018 10 21;268:217-222. Epub 2018 Jul 21.

Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, 1941 East Road, Behavioral and Biomedical Sciences Building 1316, Houston, TX, United States; UTHealth Harris County Psychiatric Center, Houston, TX, United States.

Recent advances in data science were used capitalize on the extensive quantity of data available in electronic health records to predict patient aggressive events. This retrospective study utilized electronic health records (N = 29,841) collected between January 2010 and December 2015 at Harris County Psychiatric Center, a 274-bed safety net community psychiatric facility. The primary outcome of interest was the presence (1.4%) versus absence (98.6%) of an aggressive event toward staff or patients. The best-performing algorithm, penalized generalized linear modeling, achieved an area under the curve = 0.7801. The strongest predictors of patient aggressive events included homelessness (b = 0.52), having been convicted of assault (b = 0.31), and having witnessed abuse (b = -0.28). The algorithm was also used to generate a cost-optimized probability threshold (6%) for an aggressive event, theoretically affording individualized hospital-staff coverage on the 2.8% of inpatients at highest risk for aggression, based on available hospital operating costs. The present research demonstrated the utility of a data science approach to better understand a high-priority event in psychiatric inpatient settings.
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http://dx.doi.org/10.1016/j.psychres.2018.07.004DOI Listing
October 2018

Genetic and Psychosocial Predictors of Aggression: Variable Selection and Model Building With Component-Wise Gradient Boosting.

Front Behav Neurosci 2018 7;12:89. Epub 2018 May 7.

Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas, Houston, TX, United States.

: Given datasets with a large or diverse set of predictors of aggression, machine learning (ML) provides efficient tools for identifying the most salient variables and building a parsimonious statistical model. ML techniques permit efficient exploration of data, have not been widely used in aggression research, and may have utility for those seeking prediction of aggressive behavior. : The present study examined predictors of aggression and constructed an optimized model using ML techniques. Predictors were derived from a dataset that included demographic, psychometric and genetic predictors, specifically FK506 binding protein 5 (FKBP5) polymorphisms, which have been shown to alter response to threatening stimuli, but have not been tested as predictors of aggressive behavior in adults. : The data analysis approach utilized component-wise gradient boosting and model reduction via backward elimination to: (a) select variables from an initial set of 20 to build a model of trait aggression; and then (b) reduce that model to maximize parsimony and generalizability. : From a dataset of = 47 participants, component-wise gradient boosting selected 8 of 20 possible predictors to model Buss-Perry Aggression Questionnaire (BPAQ) total score, with = 0.66. This model was simplified using backward elimination, retaining six predictors: smoking status, psychopathy (interpersonal manipulation and callous affect), childhood trauma (physical abuse and neglect), and the FKBP5_13 gene (rs1360780). The six-factor model approximated the initial eight-factor model at 99.4% of . : Using an inductive data science approach, the gradient boosting model identified predictors consistent with previous experimental work in aggression; specifically psychopathy and trauma exposure. Additionally, allelic variants in FKBP5 were identified for the first time, but the relatively small sample size limits generality of results and calls for replication. This approach provides utility for the prediction of aggression behavior, particularly in the context of large multivariate datasets.
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http://dx.doi.org/10.3389/fnbeh.2018.00089DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5949329PMC
May 2018

Distress tolerance: Associations with trauma and substance cue reactivity in low-income, inner-city adults with substance use disorders and posttraumatic stress.

Psychol Addict Behav 2018 05;32(3):264-276

Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston.

Cue reactivity has great potential to advance our understanding of posttraumatic stress disorder (PTSD), substance use disorder (SUD), and PTSD/SUD comorbidity. The present investigation examined distress tolerance (DT) with regard to trauma and substance cue reactivity. Participants included 58 low-income, inner-city adults (49.1% women; M = 45.73, SD = 10.00) with substance dependence and at least 4 symptoms of PTSD. A script-driven cue reactivity paradigm was utilized. Four DT measures were administered, including the Distress Tolerance Scale (DTS), Mirror-Tracing Persistence Task (MTPT), Breath-Holding Task (BH), and Paced Auditory Serial Addition Task (PASAT). Lower DT, as indexed by MTPT duration, was significantly predictive of greater levels of self-reported substance cravings/urges in response to trauma cues, above and beyond covariates. Lower DTS scores predicted lower levels of self-reported control/safety ratings in response to substance cues. None of the DT indices was significantly predictive of heart rate variability. Clinical and research implications are discussed. (PsycINFO Database Record
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http://dx.doi.org/10.1037/adb0000362DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5962030PMC
May 2018

An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use.

Addiction 2018 Apr 21. Epub 2018 Apr 21.

Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Background And Aims: Despite the availability of several efficacious smoking cessation treatments, fewer than 25% of smokers who quit remain abstinent 1 year post-treatment. This study aimed to determine if varenicline and bupropion combination treatment would result in higher abstinence rates than varenicline alone.

Design: A double-blind, randomized, parallel-group smoking cessation clinical trial in which participants were exposed to 12 weeks of treatment and followed for 12 months.

Setting: Hospital-based out-patient clinic in Texas, USA specializing in cancer prevention.

Participants: A total of 385 community smokers (58.44% male) who smoked 1 pack of cigarettes/day [mean = 19.66 cigarettes/day, standard deviation (SD) = 9.45]; had average carbon monoxide (CO) of 26.43 parts per million (SD = 13.74); and were moderately dependent (Fagerström Test for Cigarette Dependence = 4.79; SD = 2.07).

Interventions And Comparator: Smokers were randomized in a 3 : 1 (active: Placebo) ratio to 12 weeks of treatment as follows: placebo (n = 56), varenicline (Var; n = 166), and varenicline + bupropion (Combo; n = 163).

Measurements: A priori primary outcome: prolonged abstinence at 12 months.

Secondary Outcomes: 7-day point prevalence abstinence and continuous abstinence; all abstinence measures at end of treatment and 6-month follow-ups.

Findings: Intention-to-treat analysis: the Combo group (n = 163) failed to demonstrate superiority to the Var group (n = 166) for prolonged abstinence at 12 months [odds ratio (OR) = 0.91, 95% confidence interval (CI) = 0.50-1.64], supported by Bayes factor = 0.06. Both the Var (OR = 6.66, 95% CI = 1.61-59.27) and Combo groups (OR = 6.06, 95% CI = 1.45-54.09) demonstrated superiority to the Placebo group (n = 56; score = 8.38, P < 0.016).

Conclusions: The addition of bupropion to varenicline treatment does not appear to increase smoking abstinence rates above that of varenicline alone. The findings support previous research showing a consistently favorable effect of both varenicline and the combination of varenicline and bupropion on smoking cessation compared with placebo.
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http://dx.doi.org/10.1111/add.14250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6196126PMC
April 2018

Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial.

Medicine (Baltimore) 2018 Jan;97(2):e9567

University of Texas Health Science Center at Houston Baylor College of Medicine University of Texas MD Anderson Cancer Center, Houston, Texas Mind Springs Health, Grand Junction, Colorado.

Background: Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake. Several GLP-1 agonists are used clinically to treat type 2 diabetes and obesity, but none have been tested in humans to reduce smoking.

Aims: We will examine whether extended-release exenatide reduces smoking, craving, and withdrawal symptoms, as well as cue-induced craving for cigarettes.

Methods: We will enroll prediabetic and/or overweight treatment seeking smokers (n = 90) into a double-blind, placebo-controlled, randomized clinical trial. Participants will be randomized in a 1:1 ratio to receive exenatide or placebo. All participants will receive transdermal nicotine replacement therapy (NRT) and behavioral counseling. Abstinence from smoking (verified via expired CO level of ≤5 ppm), craving (Questionnaire of Smoking Urges score), and withdrawal symptoms (Wisconsin Scale of Withdrawal Symptoms score) will be assessed weekly during 6 weeks of treatment and at 1 and 4 weeks posttreatment. Cue-induced craving for cigarettes will be assessed at baseline and at 3 weeks of treatment following virtual reality exposure.

Expected Outcomes: We hypothesize that exenatide will increase the number of participants able to achieve complete smoking abstinence above that achieved via standard NRT and that exenatide will reduce craving and withdrawal symptoms, as well as cue-induced craving for cigarettes.
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http://dx.doi.org/10.1097/MD.0000000000009567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5943874PMC
January 2018

Development of a novel, integrated cognitive-behavioral therapy for co-occurring posttraumatic stress and substance use disorders: A pilot randomized clinical trial.

Contemp Clin Trials 2018 02 26;65:123-129. Epub 2017 Dec 26.

Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, United States.

Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric conditions that commonly co-occur. No evidence-based, 'gold standard' treatments for PTSD/SUD comorbidity are currently available. The present pilot randomized clinical trial was designed to evaluate the feasibility and preliminary efficacy of a novel, integrated cognitive-behavioral treatment approach for PTSD/SUD, entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS), as compared to standard cognitive-behavioral treatment (CBT) for SUD. The TIPSS program integrates cognitive processing therapy with CBT for SUD for the treatment of co-occurring PTSD/SUD. Both treatment conditions are comprised of 12, 60-minute individual psychotherapy sessions, delivered twice-weekly over six weeks. Primary aims examine whether TIPSS, compared to standard CBT for SUD, reduces: (1) PTSD symptoms and (2) substance use outcomes (i.e., self-report, objective). Secondary aims examine whether (a) trauma- and substance cue reactivity and (b) distress tolerance (i.e., actual or perceived ability to withstand uncomfortable emotional or physical states) are significant mechanisms of change. The study was recently closed to new enrollment. Participants included adults with substance dependence and at least four symptoms of PTSD.
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http://dx.doi.org/10.1016/j.cct.2017.12.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5803416PMC
February 2018
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