Clinical and psychosocial outcomes by sex among individuals prescribed buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX) for opioid use disorder.

BACKGROUND AND OBJECTIVES: Limited research has explored sex differences in opioid use disorder medication (MOUD) treatment outcomes. The purpose of this study was to examine MOUD initiation onto buprenorphine-naloxone (BUP-NX) versus extended-release naltrexone (XR-NTX) by sex, and sex differences in clinical and psychosocial outcomes. METHODS: Using data from a 24-week open-label comparative effectiveness trial of BUP-NX or XR-NTX, this study examined MOUD initiation (i.e., receiving a minimum one XR-NTX injection or first BUP-NX dose) and 24-week self-report outcomes. We used regression models to estimate the probability of MOUD initiation failure among the intent-to-treat sample (N = 570), and the main and interaction effects of sex on outcomes of interest among the subsample of participants who successfully initiated MOUD (n = 474). RESULTS: In the intent-to-treat sample, the odds of treatment initiation failure were not significantly different by sex. In the subsample of successful MOUD initiates, the effect of treatment on employment at week 24 was significantly moderated by sex (p = .003); odds of employment were not significantly different among males by MOUD type; females randomized to XR-NTX versus BUP-NX had 4.63 times greater odds of employment (p < .001). Males had significantly lower odds of past 30-day exchanging sex for drugs versus females (adjusted odds ratios [aOR] = 0.10, p = .004), controlling for treatment and baseline outcomes. DISCUSSION AND CONCLUSIONS: Further research should explore how to integrate employment support into OUD treatment to improve patient outcomes, particularly among women. SCIENTIFIC SIGNIFICANCE: The current study addressed gaps in the literature by examining sex differences in MOUD initiation and diverse treatment outcomes in a large, national sample.

Estimating posttraumatic stress disorder severity in the presence of differential item functioning across populations, comorbidities, and interview measures: Introduction to Project Harmony.

Multiple factor analytic and item response theory studies have shown that items/symptoms vary in their relative clinical weights in structured interview measures for posttraumatic stress disorder (PTSD). Despite these findings, the use of total scores, which treat symptoms as though they are equally weighted, predominates in practice, with the consequence of undermining the precision of clinical decision-making. We conducted an integrative data analysis (IDA) study to harmonize PTSD structured interview data (i.e., recoding of items to a common symptom metric) from 25 studies (total N = 2,568). We aimed to identify (a) measurement noninvariance/differential item functioning (MNI/DIF) across multiple populations, psychiatric comorbidities, and interview measures simultaneously and (b) differences in inferences regarding underlying PTSD severity between scale scores estimated using moderated nonlinear factor analysis (MNLFA) and a total score analog model (TSA). Several predictors of MNI/DIF impacted effect size differences in underlying severity across scale scoring methods. Notably, we observed MNI/DIF substantial enough to bias inferences on underlying PTSD severity for two groups: African Americans and incarcerated women. The findings highlight two issues raised elsewhere in the PTSD psychometrics literature: (a) bias in characterizing underlying PTSD severity and individual-level treatment outcomes when the psychometric model underlying total scores fails to fit the data and (b) higher latent severity scores, on average, when using DSM-5 (net of MNI/DIF) criteria, by which multiple factors (e.g., Criterion A discordance across DSM editions, changes to the number/type of symptom clusters, changes to the symptoms themselves) may have impacted severity scoring for some patients.

Putting the Patient Back in Clinical Significance: Moderated Nonlinear Factor Analysis for Estimating Clinically Significant Change in Treatment for Posttraumatic Stress Disorder.

The present study introduced a modernized approach to Jacobson and Truax's (1991) methods of estimating treatment effects on individual-level (a) movement from the clinical to the normative range and (b) reliable change on posttraumatic stress disorder (PTSD) severity. Participants were 450 trauma-exposed women (M age = 39.2 years, SD = 8.9, range: 18-65 years) who presented to seven geographically diverse community mental health and substance use treatment centers. Data from 53 of these women, none of whom met the criteria for full or subthreshold PTSD, were used to establish the normative range. Using moderated nonlinear factor analysis (MNLFA) scale scoring, which weights symptoms by their clinical relevance, a significantly larger proportion of participants moved into the normative range for PTSD severity scores and/or exhibited reliable changes after treatment compared to the same individuals' movement when using symptom counts. Further, approximately 24% of the participants showed discrepant judgments on reliable change indices (RCI) between MNLFA scores and symptom counts, likely due to the false assumption that the standard error of measurement is equal for all levels of underlying PTSD severity when estimating RCIs with symptom counts. An MNLFA approach to estimating underlying PTSD severity can provide clinically meaningful information about individual-level change without the de facto assumption that PTSD symptoms have equivalent weight. Study implications are discussed with regard to a joint emphasis on (a) measurement models that highlight differential symptom weighting and (b) treatment-arm differences in individual-level outcomes rather than the current overemphasis of treatment-arm differences on group-averaged trajectories.

Prevalence and Correlates of Concurrent and Simultaneous Cannabis and Cigarette Use among Past-Year Cannabis-Using US College Students.

Background: Cannabis and tobacco use are significant public health concerns among young adults, with concurrent (in the same time period) and simultaneous (at the same time so the effects overlap) use of both substances on the rise. Few studies have examined these behaviors among college students. Objective: We examined the prevalence of concurrent and simultaneous cannabis and cigarette (combustible or electronic) use among a sample of college students and characterized the psychosocial predictors of concurrent and simultaneous use compared to using cannabis alone. Methods: Data on past-3 months cannabis and cigarette use were collected on 1352 college students who were past-year cannabis and alcohol users yielding four groups: cannabis-only users (n = 686), concurrent cannabis and cigarette users (CCAC; n = 235), simultaneous cannabis and cigarette users (SCAC; n = 293), and non-recent users of either substance (n = 138). Multinomial logistic regression analyses were utilized to predict group membership. Results: Relative to the cannabis-only group, White, compared to Non-White students, males, compared to females, frequent, compared to infrequent, alcohol users, including those who used alcohol simultaneously with cigarettes, and illicit drug users were more likely to belong to the CCAC or SCAC group. Conclusions: Findings suggest the need for unique intervention efforts to prevent onset or reduce co-use among male and White students as well as illicit drug users and frequent alcohol users.

Concurrent Treatment with Prolonged Exposure for Co-Occurring Full or Subthreshold Posttraumatic Stress Disorder and Substance Use Disorders: A Randomized Clinical Trial.

BACKGROUND: To test whether an integrated prolonged exposure (PE) approach could address posttraumatic stress disorder (PTSD) symptoms effectively in individuals with co-occurring substance use disorders (SUD), we compared concurrent treatment of PTSD and SUD using PE (COPE) to relapse prevention therapy (RPT) for SUD and an active monitoring control group (AMCG). METHODS: We conducted a randomized 12-week trial with participants (n = 110; 64% males; 59% African Americans) who met Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for full or subthreshold PTSD and SUD. Participants were randomly assigned to COPE (n = 39), RPT (n = 43), or AMCG (n = 28). RESULTS: At the end-of-treatment, COPE and RPT demonstrated greater reduction in PTSD symptom severity relative to AMCG (COPE-AMCG = -34.06, p < 0.001; RPT-AMCG = -22.58, p = 0.002). Although the difference between COPE and RPT was not significant in the complete sample, the subset of participants with full (vs. subthreshold) PTSD demonstrated significantly greater reduction of PTSD severity in COPE relative to RPT. Both treatments were superior to AMCG in reducing the days of primary substance use (COPE-AMCG = -0.97, p = 0.01; RPT-AMCG = -2.07, p < 0.001). Relative to COPE, RPT showed significantly more improvement in SUD outcome at end-of-treatment (RPT-COPE = -1.10, p = 0.047). At 3-month follow-up, COPE and RPT maintained their treatment gains and were not significantly different in PTSD severity or days of primary substance use. CONCLUSION: COPE and RPT reduced PTSD and SUD severity in participants with PTSD + SUD. Findings suggest that among those with full PTSD, COPE improves PTSD symptoms more than a SUD-only treatment. The use of PE for PTSD was associated with significant decreases in PTSD symptoms without worsening of substance use.

Racial differences in adherence and response to combined treatment for full and subthreshold post-traumatic stress disorder and alcohol use disorders: A secondary analysis.

We conducted a secondary data analysis to examine whether there were racial differences in adherence and treatment outcomes for participants with co-occurring full and subthreshold post-traumatic stress disorder (PTSD) and alcohol/substance use disorders (A/SUD) who were treated with Seeking Safety (a cognitive-behavioral therapy) and sertraline or Seeking Safety and placebo as part of a clinical trial. Bivarate analyses examined the association between race and adherence, and generalized estimating equations assessed whether race moderated the effect of combination treatment on PTSD and alcohol use outcomes. Except for education, there were no statistically significant racial differences in baseline demographic and psychiatric characteristics. African Americans and Caucasians were equally adherent in number of psychotherapy and medication sessions attended and medication compliance. After controlling for baseline demographics and psychiatric symptoms, however, a race by treatment condition interaction emerged suggesting that African Americans who received the Seeking Safety and sertraline treatment had significantly lower PTSD symptom severity posttreatment and at six months follow-up compared to their counterparts who received Seeking Safety and placebo. No differential effect of treatment condition was found for Caucasians. Moreover, results indicated that a diagnosis of major depressive disorder negatively impacted PTSD symptom recovery for African American participants but not for Caucasians. In conclusion, no differences emerged between African Americans and Caucasians in adherence to combination treatments for PTSD and A/SUD. Findings also suggest assessment and treatment of MDD among African Americans may improve treatment outcomes. More research is needed to determine whether the differential response to Seeking Safety and sertraline among African Americans compared to Caucasians can be replicated.

At the crossroads: the intersection of substance use disorders, anxiety disorders, and posttraumatic stress disorder.

The co-occurrence of substance use disorders with anxiety disorders and/or posttraumatic stress disorder has been widely documented and when compared to each disorder alone, consistently linked to increased risk for a host of negative outcomes including greater impairment, poorer treatment response, and higher rates of symptom relapse. This article focuses on recent advances in the understanding and effective treatment of this common and highly complex comorbidity. Prevalence and epidemiological data are introduced, followed by a review of contemporary models of etiology and associative pathways. Conceptualizations of effective treatment approaches are discussed alongside evidence from the past decade of clinical research trials. Highlighted are ongoing questions regarding the benefit of sequential, parallel, and integrated approaches and the necessity of further investigation into the mechanisms underlying treatment efficacy. Lastly, recent contributions from neuroscience research are offered as a promising bridge for the development and testing of novel, interdisciplinary treatment approaches.

Associations between post-traumatic stress symptoms, stimulant use, and treatment outcomes: a secondary analysis of NIDA's Women and Trauma study.

BACKGROUND AND OBJECTIVES: To examine the associations between post-traumatic stress disorder (PTSD) symptoms, stimulant use, and treatment outcomes among dually diagnosed women. METHODS: Participants were 141 women who participated in a multisite clinical trial of group treatments for PTSD and addictions. RESULTS: Generalized linear models indicated Seeking Safety (SS; a cognitive-behavioral intervention) was significantly more effective than Women's Health Education (WHE; a control group intervention) in reducing stimulant use at follow-up among women who were heavy stimulant users at pre-treatment and who showed improvements in PTSD symptoms. There were no significant differences between the interventions among women who were light stimulant users at treatment entry. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: These findings suggest that integrated treatment of co-occurring PTSD and addictions may be more effective than general health education approaches for heavy stimulant users. Assessment of frequency of stimulant use among individuals with PTSD symptoms may inform treatment selection for this population.

Indirect effects of 12-session seeking safety on substance use outcomes: overall and attendance class-specific effects.

OBJECTIVES: This study examined in- and post-treatment mediation effects of a 12-session dose of Seeking Safety (SS)-an integrative cognitive behavioral treatment for comorbid PTSD and SUDs-on alcohol and cocaine outcomes in comparison to Women's Health Education (WHE) in a seven-site randomized controlled effectiveness trial. METHODS: Women (n = 353) enrolled in outpatient substance abuse treatment, who had experienced multiple traumas in childhood and/or adulthood and who had comorbid PTSD, were randomly assigned to receive SS or WHE delivered in open enrollment groups for 12 sessions in 6 weeks (unlike the full 25-topic SS protocol). Data were analyzed under two forms of longitudinal mediation analysis, each accounting for changes over time in group membership and group context, respectively. RESULTS: Women in SS, compared to WHE, showed significantly steeper decreases in PTSD frequency and severity, which in turn, showed significant impact in reducing both cocaine and alcohol use. This pattern was strongest for those who completed most of the treatment sessions, which was the majority of patients in the trial; these patterns only emerged during the in-treatment phase. CONCLUSIONS: Use of an integrated approach to PTSD/SUD such as SS can be helpful to more rapidly reduce PTSD, which consequently reduce SUD symptoms, particularly for those who attend most of the available treatment sessions. SCIENTIFIC SIGNIFICANCE: This is one of the first studies to illustrate such effects in treating comorbid PTSD and SUD in the context of a highly impaired population delivered by community-based providers. (Am J Addict 2014;23:218-225).

Racial/ethnic match and treatment outcomes for women with PTSD and substance use disorders receiving community-based treatment.

This study examined the relationship between racial/ethnic match and treatment outcomes for 224 women who participated in a clinical trial of group treatments for posttraumatic stress disorder (PTSD) and substance use disorders. Generalized estimating equations were used to examine the effect of client-therapist racial/ethnic match on outcomes. Results revealed racial/ethnic match was not significantly associated with session attendance. There was a significant three-way interaction between client race/ethnicity, baseline level of PTSD symptoms, and racial/ethnic match on PTSD outcomes. White clients, with severe PTSD symptoms at baseline, who attended treatment groups where they were matched with their therapist, had greater reductions in PTSD symptoms at follow-up than their counterparts who were racially/ethnically mismatched with their group therapist. Racial/ethnic match did not confer additional benefits for Black clients in terms of PTSD outcomes. Racial/ethnic match interacted with baseline substance use to differentially influence substance use outcomes at follow-up for all women. Clinical implications are discussed.

It's not just Black and White: Identifying the combined influence of multi-level determinants of tobacco use among Black adolescents.

OBJECTIVE: Black individuals are disproportionately affected by tobacco-related illnesses. Although tobacco use is often initiated in adolescence and risk factors thereof originate from multiple domains of influence, investigations of tobacco use among Black adolescents seldom consider these multiple domains simultaneously. These examinations are needed to identify the influence of co-occurring risk factors on tobacco use and inform comprehensive tobacco prevention and treatment programs. Our study sought to identify the combined influence of factors across multiple domains on tobacco use among Black adolescents. METHOD: Participants were Non-Hispanic Black (N = 1,801) adolescent (age 12-17 years) respondents from Wave 1 of the Population Assessment of Tobacco and Health study. Latent class analysis identified unique response patterns to items assessing risk of tobacco use across sociocultural, environmental, psychological, and behavioral (e.g., alcohol use) domains. Subsequent logistic regressions compared the odds of ever and current tobacco use between the classes. RESULTS: Four latent classes were identified. According to item response probabilities they were named: Low Risk (LR: 36.5%), Low Psychological (LP: 19.0 %), High Psychological (HP: 30.4%) and High Social, Psychological, and Behavioral (HSPB: 14.1%) risk. The odds of ever and current tobacco use were highest among adolescents in the HSPB latent class compared to the other latent classes (odds ratio: 6.5 to 42.1). CONCLUSIONS: Adolescents with the highest odds of tobacco use endorse multiple risks including feeling distress, perceiving tobacco as beneficial for handling stress, and using substances, and may prioritize the management of negative emotions over perceived health consequences from tobacco use. Multi-level interventions that incorporate the development of coping strategies for effectively handling negative affect may prove highly effective in preventing tobacco use among Black adolescents.

Project harmony: A systematic review and network meta-analysis of psychotherapy and pharmacologic trials for comorbid posttraumatic stress, alcohol, and other drug use disorders.

We conducted a systematic review and network meta-analyses (NMA) of psychotherapy and pharmacologic treatments for individuals with co-occurring posttraumatic stress disorder (PTSD) and alcohol or other drug use disorder (AOD). A comprehensive search spanning 1995-2019 yielded a pool of 39 studies for systematic review, including 24 randomized controlled trials for the NMA. Study interventions were grouped by target of treatment (PTSD + AOD, PTSD-only, and AOD-only) and approach (psychotherapy or medication). Standardized mean differences (SMD) from the NMA yielded evidence that at the end of treatment, integrated, trauma-focused therapy for PTSD + AOD was more effective at reducing PTSD symptoms than integrated, non-trauma-focused therapy (SMD = -0.30), AOD-focused psychotherapy (SMD = -0.29), and other control psychotherapies (SMD = -0.43). End-of-treatment alcohol use severity was less for AOD medication compared to placebo medication (SMD = -0.36) and trauma-focused therapy for PTSD + placebo medication (SMD = -0.67), and less for trauma-focused psychotherapy + AOD medication compared to PTSD medication (SMD = -0.53), placebo medication (SMD = -0.50), and trauma-focused psychotherapy + placebo medication (SMD = -0.81). Key limitations include the small number of studies in the NMA for pharmacologic treatments and the lack of demographic diversity apparent in the existing literature. Findings suggest room for new studies that can address limitations in study sample composition, sample sizes, retention, and apply new techniques for conducting comparative effectiveness in PTSD + AOD treatment. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Cannabis use and trauma-focused treatment for co-occurring posttraumatic stress disorder and substance use disorders: A meta-analysis of individual patient data.

High rates of cannabis use among people with posttraumatic stress disorder (PTSD) have raised questions about the efficacy of evidence-based PTSD treatments for individuals reporting cannabis use, particularly those with co-occurring alcohol or other substance use disorders (SUDs). Using a subset of four randomized clinical trials (RCTs) included in Project Harmony, an individual patient meta-analysis of 36 RCTs (total N = 4046) of treatments for co-occurring PTSD+SUD, we examined differences in trauma-focused (TF) and non-trauma-focused (non-TF) treatment outcomes for individuals who did and did not endorse baseline cannabis use (N = 410; 70% male; 33.2% endorsed cannabis use). Propensity score-weighted mixed effects modeling evaluated main and interactive effects of treatment assignment (TF versus non-TF) and baseline cannabis use (yes/no) on attendance rates and within-treatment changes in PTSD, alcohol, and non-cannabis drug use severity. Results revealed significant improvements across outcomes among participants in all conditions, with larger PTSD symptom reductions but lower attendance among individuals receiving TF versus non-TF treatment in both cannabis groups. Participants achieved similar reductions in alcohol and drug use across all conditions. TF outperformed non-TF treatments regardless of recent cannabis use, underscoring the importance of reducing barriers to accessing TF treatments for individuals reporting cannabis use.

The relative contribution of ethnic identity and ethnic discrimination on alcohol, tobacco, and other drug use disorders among Hispanic/Latin American individuals.

INTRODUCTION: Racial/ethnic discrimination and ethnic identity, the affiliation and connection to one's ethnic group, are important for understanding alcohol, tobacco, and drug use disorders (AUD, TUD, DUD, respectively) among Hispanic/Latin American individuals. Although discrimination is a well-recognized risk factor, the role of ethnic identity is less understood. Moreover, no study has examined which of these factors is more important for informing AUD, TUD, and DUD. This information is necessary for creating effective prevention and treatment programs tailored for Hispanic/Latin American people. Herein we examined the role and relative importance of racial/ethnic discrimination and Hispanic ethnic identity on past year AUD, TUD, and DUD. METHODS: Hispanic/Latin American participants of the National Epidemiologic Survey on Alcohol and Related Conditions-III constituted the sample for this cross-sectional secondary data analysis. Participants (N = 7037) were 39.93 years old on average (SD = 15.32). More than half were female (56.1 %) and had family incomes below the median household income in the United States (58.7 %). Most had national origins in North America (79.3 %), including US dependent territories and Mexico. Confirmatory factor analysis (CFA) verified the psychometric properties of the discrimination and Hispanic ethnic identity measures. Logistic regressions, supplemented with dominance analysis, estimated the role and relative contribution of discrimination and Hispanic ethnic identity on the probability of past year AUD, TUD, and DUD. RESULTS: The CFAs yielded adequate convergent validity and reliability for each construct. More racial/ethnic discrimination and a higher Hispanic ethnic identity related to a higher and lower probability of AUD, TUD, and DUD, respectively. The magnitude of the association between Hispanic ethnic identity and the probability of TUD exceeded that of racial/ethnic discrimination, but the converse was the case for AUD and DUD. CONCLUSIONS: Prevention and treatment programs for TUD that highlight the value of having a strong sense of self as a member of a Hispanic ethnic group, and that encourage the individual to explore their Hispanic ancestry may prove effective among Hispanic/Latin American individuals, particularly those who have experienced racial/ethnic discrimination. Programs for AUD and DUD tailored for Hispanic Latin/American adults should also incorporate coping strategies to address experiences with racial/ethnic discrimination.

Differences among factors associated with tobacco product use among Black and White adolescents: A cross-sectional analysis of wave one of the PATH study 2013-2014.

INTRODUCTION: Tobacco use remains a primary cause of health disparities between Black and White Americans. Current approaches have not improved tobacco-related racial health disparities. This study aimed to identify differences in factors associated with tobacco product use among Black and White adolescents. METHODS: This cross-sectional design used data from Wave One (2013-2014) of the Population Assessment of Tobacco and Health Study. Adolescents aged 12-17 years who identified as non-Hispanic Black or African American (n=1800) or non-Hispanic White (n=6495) were included. Primary outcomes were the ever use and current use of any tobacco products. Sociocultural, household environment, psychological, and behavioral factors were included. Logistic regressions, stratified by race, were used to determine significance. Dominance analysis was used to rank significant factors by their level of importance. RESULTS: Although there were many Black-White commonalities, there were also important differences. Black adolescents in the Northeast were more likely to have ever used tobacco compared to those in the South (OR=0.6; 95% CI: 0.6-0.7, p<0.001) and Midwest (OR=0.6; 95% CI: 0.5-0.7, p<0.001). White adolescents in the Northeast were less likely to use tobacco products than in other regions. Peer influences (OR=1.9; 95% CI: 1.1-3.2, p<0.05) were uniquely associated with ever use among Black adolescents. Access to tobacco in the home (OR=2.0; 95% CI: 1.4-3.0, p<0.001) and thinking that tobacco use would help reduce stress (OR=1.3; 95% CI: 1.1-1.6, p<0.01) were uniquely associated with current use among Black adolescents. CONCLUSIONS: There are significant Black-White differences in the factors associated with tobacco use. Factors uniquely associated with Black adolescent tobacco use should be considered in developing strategies to prevent adolescent tobacco use in Black communities.

Attitudes about Cigarette Smoking, Perceived Consequences of Smoking, and Seeking Assistance with Cessation among Black and White Cigarette Smokers: A Qualitative Study.

Introduction: Research has identified significant racial differences in cigarette smoking behavior, associated disease risk, likelihood of cessation, and mortality from smoking-related diseases. The current study assessed, via qualitative narrative analysis, racial differences in participants' motivations for smoking, perceived consequences of smoking, and how participants deal with cravings/withdrawal, as well as thoughts and feelings about quitting, seeking assistance with quitting, and the importance of social support in quitting. Methods: Semistructured interviews were conducted with 11 Black and 11 White cigarette smokers. Data were analyzed using the Thematic Networks Analysis process, which entailed coding the data and constructing thematic networks by identifying basic and organizing themes. Results: While there were no descriptive racial differences identified in participants' motivation for smoking or perceived consequences of smoking, differences existed between Blacks and Whites in terms of approaches in dealing with smoking cravings and withdrawal, perceived self-efficacy in controlling cravings, preferred methods of learning about and receiving smoking cessation assistance, and overall preference for receiving cessation-related support. Conclusions: Further investigation is needed into racial differences in methods to deal with cigarette cravings and withdrawal, preferences for receiving cessation information, and social support for cessation. This research will further develop our understanding of and ability to address factors underlying racial disparities in smoking behavior and cessation, as well as inform the development of future smoking cessation interventions.

Integrative data analysis of clinical trials network studies to examine the impact of psychosocial treatments for black people who use cocaine: Study protocol.

BACKGROUND: Cocaine overdose death rates among Black people are higher than that of any other racial/ethnic group, attributable to synthetic opioids in the cocaine supply. Understanding the most effective psychostimulant use treatment interventions for Black people is a high priority. While some interventions have proven effective for the general population, their comparative effectiveness among Black people remains unknown. To address this gap, our NIDA-funded Clinical Trials Network (CTN) study (0125), will use Integrative Data Analysis (IDA) to examine treatment effectiveness across 9 CTN studies. This manuscript describes the study protocol for CTN-0125. METHODS: Of the 59 completed randomized clinical trials in the CTN with available datasets, nine met our inclusion criteria: 1) behavioral intervention, 2) targeted cocaine use or use disorder, 3) included sub-samples of participants who self-identified as Black and 4) included outcome measures of cocaine and psychostimulant use and consequences. We aim to 1) estimate scale scores of cocaine use severity while considering study-level measurement non-invariance, 2) compare the effectiveness of psychosocial treatments for psychostimulant use, and 3) explore individual (e.g., concomitant opioid use, age, sex, employment, pre-treatment psychiatric status) and study-level moderators (e.g., attendance/retention) to evaluate subgroup differences in treatment effectiveness. CONCLUSION: The NIDA CTN provides a unique collection of studies that can offer insight into what interventions are most efficacious for Black people. Findings from our CTN-0125 study have the potential to substantially inform treatment approaches specifically designed for Black people who use psychostimulants.

Project Harmony: A Meta-Analysis With Individual Patient Data on Behavioral and Pharmacologic Trials for Comorbid Posttraumatic Stress and Alcohol or Other Drug Use Disorders.

OBJECTIVE: Treatment efficacy for co-occurring posttraumatic stress disorder (PTSD) and substance use disorders is well established, yet direct evidence for comparative effectiveness across treatments is lacking. The present study compared the effectiveness of several behavioral and pharmacological therapies for adults with co-occurring PTSD and alcohol or other drug use disorders. METHODS: A systematic search of PsycINFO, MEDLINE, and ClinicalTrials.gov was conducted through December 2020 for trials targeting PTSD, alcohol or other drug use disorders, or both disorders (36 studies, N=4,046). Primary outcomes were severity scores for PTSD, alcohol use, and drug use, estimated via moderated nonlinear factor analysis. Propensity score weight-adjusted multilevel models were used. Model-predicted effect sizes were estimated for each treatment, and comparative effect sizes for each active arm against treatment as usual, at end of treatment and at 12-month follow-up. RESULTS: Compared with treatment as usual, combining trauma-focused therapy and pharmacotherapy for substance use disorders showed the largest comparative effect sizes for PTSD severity (d=-0.92, 95% CI=-1.57, -0.30) and alcohol use severity (d=-1.10, 95% CI=-1.54, -0.68) at end of treatment. Other treatments with large comparative effect sizes included pharmacotherapies for alcohol or other drug use disorders, trauma-focused integrated therapies, and trauma-focused nonintegrated therapies. Reductions in outcomes for PTSD symptoms and alcohol use were observed for nearly all treatments. CONCLUSIONS: The findings provide support for treating comorbid PTSD and substance use disorders using a variety of approaches, with alcohol-targeted pharmacotherapies and trauma-focused behavioral therapies as a combination of treatments that lead to early and sustained improvements in PTSD and alcohol use severity. Further treatment development is indicated for combining behavioral and pharmacological treatments for synergized impact and understanding the mechanisms of action and conditions under which each treatment type is optimized.

Differential symptom weighting in estimating empirical thresholds for underlying PTSD severity: Toward a "platinum" standard for diagnosis?

OBJECTIVE: Symptom counts as the basis for Post-Traumatic Stress Disorder (PTSD) diagnoses in the DSM presume each symptom is equally reflective of underlying disorder severity. However, the "equal weight" assumption fails to fit PTSD symptom data when tested. The present study developed an enhanced PTSD diagnosis based on (a) a conventional PTSD diagnosis from a clinical interview and (b) an empirical classification of full PTSD that reflected the relative clinical weights of each symptom. METHOD: Baseline structured interview data from Project Harmony (N = 2658) was used. An enhanced diagnosis for full PTSD was estimated using an empirical threshold from moderated nonlinear factor analysis (MNLFA) latent PTSD scale scores, in combination with a full conventional PTSD diagnosis based on interview data. RESULTS: One in 4 patients in the sample had a PTSD diagnosis that was inconsistent with their empirical PTSD grouping, such that the enhanced diagnostic standard reduced the diagnostic discrepancy rate by 20%. Veterans, and in particular female Veterans, were at greatest odds for discrepancy between their underlying PTSD severity and DSM diagnosis. CONCLUSION: Psychometric methodologies that differentially weight symptoms can complement DSM criteria and may serve as a platform for symptom prioritization for diagnoses in future editions of DSM.

Helping alliance, retention, and treatment outcomes: a secondary analysis from the NIDA Clinical Trials Network Women and Trauma Study.

We examined the association between the therapeutic alliance and treatment outcomes among 223 women with posttraumatic stress disorder (PTSD) and substance use disorders who participated in a multisite clinical trial of group treatments for trauma and addictions in the United States throughout 2004 and 2005. General linear models indicated that women who received Seeking Safety, a cognitive-behavioral treatment, had significantly higher alliance ratings than those in Women's Health Education, a control group. Alliance was related to significant decreases in PTSD symptoms and higher attendance in both interventions. Alliance was not related to substance use outcomes. Implications and limitations of the findings are discussed.