Variation in Opioid Agonist Dosing in Clinical Trials by Race and Ethnicity.

Importance: Racial and ethnic disparities in access to treatment and quality of treatment for opioid use disorder (OUD) have been identified in usual care settings. In contrast, disparities in treatment quality within clinical trials are relatively unexamined. Objective: To estimate racial and ethnic differences in the dose of opioid agonist treatment for OUD in the first 4 weeks of treatment in clinical trials. Design, Setting, and Participants: This cohort study performed analysis of the methadone and buprenorphine treatment arms of 3 trials conducted by the National Institute on Drug Abuse Clinical Trials Network between May 2006, and January 31, 2017, at multiple Clinical Trials Network sites across the US. Trial participants who were randomized to and initiated buprenorphine or methadone treatment and who identified as Hispanic, non-Hispanic Black, or non-Hispanic White were included in the present study. Data were analyzed from November 1, 2023, to August 5, 2024. Exposure: Combined race and ethnicity as self-classified by the patient at trial enrollment. Main Outcomes and Measures: The maximum daily dose of buprenorphine or methadone received in each week for the first 4 weeks of treatment. The mean dose and the percentage of patients receiving a higher dose (buprenorphine ≥16 mg and methadone ≥60 mg) were compared across race and ethnicity groups. Results: A total of 1748 patients (1263 who initiated buprenorphine and 485 who initiated methadone treatment) were included in the analysis (1168 [66.8%] male; median age, 33 [IQR, 26-45] years). Of these, 138 patients (7.9%) identified as Black, 273 (15.6%) as Hispanic, and 1337 (76.5%) as White. In week 4, Black patients received buprenorphine doses 2.5 (95% CI -4.6 to -0.5) mg lower and methadone doses 16.7 (95% CI, -30.7 to -2.7) mg lower compared with White patients, after standardizing by age and sex. In week 4, the percentage of patients receiving a higher dose of medication (buprenorphine ≥16 mg; methadone ≥60 mg) was 16.9 (95% CI, -31.9 to -1.9) points lower for Black patients compared with White patients. Hispanic and White patients received similar buprenorphine doses; Hispanic patients received lower methadone doses than White patients. Conclusions and Relevance: In this cohort study of data from 3 clinical trials, White patients generally received higher doses of medication than Black patients. Future research is needed to understand the mechanisms of and interventions to reduce disparities in OUD treatment quality and how such disparities impact generalizability of trial results.

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.

Dual Pandemics: Race-Related COVID Stress and Mental Health Outcomes in Black Individuals.

Black individuals have been disproportionately affected by the COVID-19 pandemic, likely due in part to historically rooted stressors that lie at the intersection of the COVID-19 pandemic and racism. We used secondary data from The Association of Black Psychologists' multi-state needs assessment of 2480 Black adults to examine the link between race-related COVID stress (RRCS) and mental health outcomes. We also examined the moderating roles of everyday discrimination, cultural mistrust, Black activism, Black identity, and spirituality/religiosity in these associations. T-tests revealed that several demographic and cultural factors are associated with RRCS endorsement. A series of regression analyses showed that endorsement of RRCS is associated with higher psychological distress and lower well-being, above and beyond several sociodemographic characteristics. While traditional cultural protective factors did not buffer against the effects of RRCS on mental health, cultural mistrust strengthened the positive association between RRCS and psychological distress; nonetheless, the association of cultural mistrusts with psychological distress was only seen in those who endorsed RRCS. We provide recommendations for policymakers, clinicians, and researchers to consider the impact of RRCS when addressing Black mental health and well-being in the age of COVID-19.

Cultural and Psychosocial Correlates of co-use among Black-White Biracial Adults.

INTRODUCTION: Biracial individuals, a subset of the fastest growing population segment in the United States, frequently experience conflict with ethnic identity, according to marginality theory. Ethnic identity is associated with perceived discrimination and self-esteem, and each of these factors is associated with alcohol and marijuana use. Some research suggests that Black-White biracial individuals have specific challenges with ethnic identity, discrimination, and self-esteem, as well as have disproportionate rates of alcohol and marijuana use separately. Co-use of these substances is linked to more risk behaviors and greater quantity/frequency of use compared to singular use of alcohol or marijuana. However, research examining these cultural and psychosocial factors as correlates of recent co-use among Black-White biracial individuals is limited. METHOD: The current study examined past-year cultural (i.e., ethnic identity, perceived discrimination) and psychosocial (i.e., age, gender, self-esteem) factors associated with past 30-day co-use (i.e., alcohol, marijuana) among a sample of 195 biracial (Black-White) adults recruited and surveyed via MTurk. We analyzed data using a hierarchical logistic regression. RESULTS: Results of the final step of logistic regression indicate increases in perceived discrimination were significantly associated with a 1.06 times greater likelihood in 30-day co-use (95% CI [1.002, 1.10]; p = .002). Further, co-use is more common among women than men (OR = 0.50, 95% CI [0.25, 0.98]; p = .04). CONCLUSIONS: Findings indicate discrimination experienced among Black-White biracial adults is the most culturally relevant correlate of recent co-use in this study, of the factors measured given the framework. As such, substance use treatment with this population may focus on experiences of and coping with discrimination. Since women were also at greater risk for co-use, gender-specific treatments may be beneficial for this population. The article also discussed other culturally relevant treatment considerations.

The Influence of Distressed Coping on the Relationship between Perceived Racial Discrimination and Cannabis Use among Black College Students.

Approximately one in five Black students report cannabis use, which is associated with academic challenges, mental health, and interpersonal problems. Understanding motivators to use cannabis among Black students at predominantly White institutions (PWIs) warrants more research. Perceived racial discrimination (PRD), believing one is treated unjustly due to race, is related to substance use and variables associated with poor coping, such as depression and anxiety. Given that research is unavailable for Black college students on the factor structure of the Everyday Discrimination Scale (EDS) using chronicity-based coding, the first aim of the study is to examine the factor structure of the chronicity-based version of the EDS. The second aim is to investigate whether distressed coping is an intervening construct between PRD and cannabis use among Black college students. Participants, recruited from a midwestern PWI (N = 119), completed the EDS, the coping subscale of the Comprehensive Marijuana Motivations Measure, and reported past-year cannabis use. Factor analysis examined the measurement model of the EDS, while path analysis assessed the mediation models. A two-factor model assessing subtle and blatant PRD on the EDS fit the data. The path analysis revealed that distressed coping fully mediated the relationship between subtle PRD and cannabis use. Distressed coping did not mediate the relation between blatant PRD and cannabis use. Institutions might focus on reducing PRD and provide support to Black students to lessen its link to distressed coping and cannabis use.

Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.

Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial ("X:BOT") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.

Hispanic participants in the National Institute on Drug Abuse's Clinical Trials Network: A scoping review of two decades of research.

INTRODUCTION: Hispanics significantly underutilize substance abuse treatment and are at greater risk for poor treatment outcomes and dropout. Two decades of research from the National Drug Abuse Treatment Clinical Trials Network (CTN) offers an opportunity to increase our understanding in how to address the disparities experienced by Hispanics in substance abuse treatment. METHODS: A scoping review was utilized to determine what has been learned from the CTN about Hispanic populations with substance use disorder. A systematic search was conducted within the CTN Dissemination Library and nine databases. Potentially relevant studies were independently assessed by two reviewers for inclusion. RESULTS: Twenty-four studies were included in the review. Results identified issues in measurement, characteristics of Hispanic substance use, effective interventions, and gaps for future research. Characteristics that interfere with treatment participation were also identified including low employment rates, less likelihood of having insurance, lower rates of internet access, and increased travel time to services, as were treatment issues such as high rates of alcohol and tobacco use. Effective interventions were identified; however, the effectiveness of these interventions may be limited to specific factors. CONCLUSIONS: Despite efforts to improve inclusion of minority populations, Hispanics remain underrepresented in clinical trials. Future research including Hispanic populations should examine measurement equivalence and consider how cultural and historical experiences, as well as patient characteristics, influence utilization of services. Finally, more studies are needed that examine the impact of structural factors that act as barriers to treatment access and engagement and result in significant disparities in treatment outcomes.

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

BACKGROUND AND OBJECTIVES: We examined age differences across genders in clinical characteristics in emerging adult (≤25 years) vs older adult patients (26+ years) with opioid use disorder (OUD). METHODS: Participants (N = 570; 30% female) entering a comparative effectiveness medication trial of buprenorphine vs extended-release naltrexone. RESULTS: Differences in clinical characteristics in emerging adult vs older participants were similar across genders. However, women 26+ years reported more mental health problems compared with women ≤25, while men ≤25 years reported more mental health problems compared with men 26+ years. DISCUSSION AND CONCLUSION: Different strategies for emerging adult and older patients seeking OUD treatment may be necessary to address psychiatric comorbidities that differ across genders in this population. SCIENTIFIC SIGNIFICANCE: Comprehensive psychiatric assessment should be systematically included in OUD treatment for all genders. Treatment should focus on the emerging adult developmental phase when appropriate, with psychiatric treatment tailored for women and men, separately, across the lifespan. (Am J Addict 2020;29:536-542).

Evaluating the Feasibility of Implementing an HIV Prevention Intervention for Incarcerated African American Men: Lessons Learned From a Pilot Study.

This pilot study evaluated the feasibility of implementing an evidence-based, culturally adapted HIV intervention with substance-using African American men in a prison setting. We recruited 60, soon-to-be released African American male prisoners from a larger study (N = 211) to be randomly selected for participation in the group-based HIV intervention, Real Men Are Safe-Culturally Adapted (REMAS-CA). Participants who were not selected for participation in the intervention received standard Centers for Disease Control and Prevention HIV prevention counseling education, provided during participant assessment in the larger study. Nearly all of the participants who were selected to participate (87%) completed the REMAS-CA intervention. To examine feasibility, data were collected about any revisions made to the HIV intervention components for the prison setting, time needed to implement the program in full, details of implementing the intervention to ensure participation and maintain retention, and participant perception of the intervention. Revisions to the intervention included reducing the number of sessions from five to three, modifying the protocol language based on the setting, and removing six activities deemed inappropriate and/or unallowable by the prison officials. The cultural considerations and intervention, overall, were well received by the participants. However, several revisions made specific to the prison and its administration could affect the potential effectiveness of the intervention. Future research is needed to determine the effectiveness of REMAS-CA among this community.

Best practices for researching diverse groups.

The elimination of health and other disparities requires high quality and methodologically sound research on racial/ethnic minorities. Despite a general consensus on the need for valid research on racial/ethnic minorities, few guidelines are available. This article contributes to closing this gap by discussing examples and strategies for addressing concrete issues that researchers may face during these stages of the scientific process: planning and literature review (identifying meaningful gaps and appropriate theoretical perspectives), design (caveats of race-comparison, selection of appropriate terminology), measurement (measurement equivalence, effects of ethnicity of the interviewer/coder), recruitment (barriers and strategies to facilitate recruitment), data analysis (use of norms derived from other groups, hazards of combining ethnic groups in the analyses), and dissemination of study findings to professional and lay audiences. Applying appropriate methodology will result in research that may impact disparities. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Research on women with substance use disorders: Reviewing progress and developing a research and implementation roadmap.

BACKGROUND: Research on women with substance use disorders has expanded, yet knowledge and implementation gaps remain. METHODS: Drawing from topics discussed at the 2017 meeting of InWomen's in Montreal, Canada, this article reviews key progress in research on substance use among women, adolescents, and families to delineate priorities for the next generation of research. RESULTS: The field has seen significant accomplishments in multiple domains, including the management of pregnant women with substance use and comorbid psychiatric disorders, caring for neonates in opioid withdrawal, greater inclusion of and treatment options for LGBTQ + communities, gendered instrumentation, and gender-focused HIV interventions for adolescent girls and women. Women who use alcohol and other drugs often experience other comorbid medical conditions (chronic Hepatitis C and HIV), contextual confounders (intimate partner violence exposure, homelessness, trauma), and social expectations (e.g., as caretakers) that must be addressed as part of integrated care to effectively treat women's substance use issues. Although significant advances have been made in the field to date, gender-based issues for women remain a neglected area in much of substance abuse research. Few dedicated and gender-focused funding opportunities exist and research has been siloed, limiting the potential for collaborations or interdisciplinary cross-talk. CONCLUSION: Given renewed attention to substance use in the context of the burgeoning opioid epidemic and shifts in global politics that affect women's substance use, the field requires a strategic rethink to invigorate a pipeline of future research and researchers.

Strength in the midst of pain: Abuse as a predictor of sexual relationship power among substance-abusing Black women.

The aim of this research was to explore the association of abuse experiences (child sexual abuse and adult physical/sexual violence) to sexual relationship power among Black substance-abusing women. The study was a secondary analysis of baseline data collected from 124 Black women in 12 drug treatment programs across the United States who initially participated in an HIV risk reduction trial conducted within the National Drug Abuse Treatment Clinical Trials Network of the National Institute on Drug Abuse (NIDA). The findings revealed that adult sexual abuse, but not childhood sexual or adult physical abuse, was associated with lower relationship control and decision-making dominance as measured by the Sexual Relationship Power Scale. The findings suggest that designing and implementing sexual risk reduction interventions that address adult sexual violence may enhance the relationship power of Black substance-abusing women and in turn may promote safer sex practices.

Does change in readiness influence retention among African American women and men in substance abuse treatment?

African Americans are less likely than other racial groups to engage in and complete outpatient substance abuse treatment. The current study, conducted as a secondary analysis of a multisite randomized clinical trial, examined whether readiness to change (RTC) over time influences retention and whether gender moderates the relationship between changes in RTC and retention among 194 African American women and men. Participants completed the University of Rhode Island Change Assessment at baseline and at the end of the 16-week study. Findings revealed a significant relationship between RTC over time and retention. Specifically, the more RTC increased throughout the 16-week study, the longer participants remained in treatment. In addition, gender moderated the relationship between changes in RTC and retention, with a stronger association between changes in RTC and retention among men relative to women. One approach to improving substance abuse treatment retention rates is to focus on increasing RTC during treatment, especially among African American men.

A cross-sectional assessment of the long term effects of brief strategic family therapy for adolescent substance use.

BACKGROUND: Young adult drug use and law-breaking behaviors often have roots in adolescence. These behaviors are predicted by early drug use, parental substance use disorders, and disrupted and conflict-ridden family environments. AIM: To examine long-term outcomes of Brief Strategic Family Therapy (BSFT) compared to treatment as usual (TAU) in the rates of drug use, number of arrests and externalizing behaviors in young adults who were randomized into treatment conditions as adolescents. DESIGN: 261 of 480 adolescents who had been randomized to BSFT or TAU in the BSFT effectiveness study were assessed at a single time, 3-7 years post randomization. METHODS: Assessments of drug use, externalizing behaviors, arrests and incarcerations were conducted using Timeline Follow Back, Adult Self Report, and self-report, respectively. Drug use, arrests and incarcerations were examined using negative binomial models and externalizing behaviors were examined using linear regression. RESULTS: When compared with TAU, BSFT youth reported lower incidence of lifetime (IRR = 0.68, 95%CI [0.57, 0.81]) and past year (IRR = 0.54, 95%CI [0.40, 0.71]) arrests; lower rates of lifetime (IRR = 0.63, 95%CI [0.49, 0.81]) and past year (IRR = 0.70, 95%CI [0.53, 0.92]) incarcerations; and lower scores on externalizing behaviors at follow-up (B = -0.42, SE = .15, p = .005). There were no differences in drug use. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: BSFT may have long term effects in reducing the number of arrests, incarcerations and externalizing problems. These effects could be explained by the improvements in family functioning that occurred during the effectiveness study. This study contributes to the literature by reporting on the long term outcomes of family therapy for adolescent drug abuse.