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This is the primary outcomes article for CTN-0080-A-2. Introduction: Racial and ethnic inequities persist in medication treatment initiation and adherence for pregnant and postpartum people with opioid use disorder (OUD). Our objective was to understand the experiences of “positive outliers,” specifically pregnant and postpartum people of color with OUD who utilized medication treatment and engaged in a randomized clinical trial for buprenorphine despite historical, cultural, and structural barriers.

Methods: We conducted two sets of semi-structured qualitative interviews. First, trained peers with lived expertise as mothers in recovery interviewed individuals who identified with a non-white race and/or ethnicity and enrolled in the Medication Treatment for OUD in Expectant Mothers (MOMs) trial (NCT03918850). Second, we interviewed principal investigators, clinicians, and research coordinators from the 13 MOMs trial sites. We used an inductive thematic approach informed by the Social Ecological Model of Racism and Anti-Racism. Transcripts were double-coded and reviewed until consensus was reached. Preliminary findings from participant and staff interviews were merged and triangulated with peers to inform theme development.

Results: We completed 17 interviews with MOMs trial participants from 7 sites. Participants identified as Hispanic (29%), Black non-Hispanic (24%), multi-racial Hispanic (18%), multi-racial non-Hispanic (18%), and American Indian, Native Hawaiian, or Pacific Islander (12%). Thirty-two interviews with trial staff were also completed. Three themes emerged: (1) Although some participants expected racist treatment and research exploitation, all participants interviewed reported non-discriminatory, non-judgmental care within the MOMs trial; (2) Compassionate care, frequent, personalized, and integrated encounters, and emotional support helped counteract prior stigmatizing and discriminatory health care interactions, enabling participants of color to feel particularly supported, trusted, and empowered during the MOMs trial; and (3) Despite pervasive cultural stigma around addiction and concerns about taking an investigational drug while pregnant, participants expressed that pregnancy status, care team trust, and transparent communication with MOMs trial staff encouraged medication utilization and adherence.

Conclusion: Facilitators of successful engagement in the MOMs trial and retention in medication treatment among pregnant and postpartum people of color with OUD included non-judgmental care, sustained trust, and frequent contact. Key perinatal OUD clinical interventions and trial improvements include personalized communication and scheduling flexibility to promote engagement of marginalized populations.

Related protocols: CTN-0080-A-2

Background and aims: Despite similar substance use levels, Black adults experience greater family, legal, employment and other social-contextual challenges related to recovery than other groups. Substance use treatments that address both substance use and social-contextual factors are uniquely positioned to address these substance-related problems and produce more sustainable improvements in social functioning than treatment as usual (TAU) or behavioral controls (Control). The aim of this study was to evaluate changes in substance-related problems among Black adults, focusing on the comparative effectiveness between social-contextual treatments and TAU/Control.

Design: Individual-level data synthesis based on secondary analysis of Black adults enrolled in the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN).

Setting: All data were collected in the primary studies between 2001 and 2008 at clinics across the United States.

Participants: Black adults who reported cocaine and/or opioid use across nine studies within the NIDA CTN. The sample used herein consisted of individuals from five of these studies who provided data on substance-related problems (n=532; mean age=39.34; standard deviation=9.6).

Measurements: There were two treatment conditions: Social-contextual (e.g. Motivational Interviewing, Seeking Safety, STAGE 12) and TAU/Control. Moderated nonlinear factor analysis estimated latent scores for substance-related problems, using subscales from the Addiction Severity Index, while accounting for measurement noninvariance across studies, time and covariates. Linear mixed models estimated latent score differences over time between social-contextual treatments and TAU/Control during treatment and from the end of treatment through 12-month follow-up.

Findings: Both treatment groups improved across substance-related problem areas from baseline to the end-of-treatment (Cohen’s d = -0.10 to d = -0.47), with effects maintained at 12-month follow-up. Although social-contextual treatments did not statistically significantly outperform TAU/Control from baseline to end-of-treatment, they showed greater effects from end of treatment to 12-month follow-up in family/social [Cohen’s d difference ( d) = -0.47, 95% confidence interval (CI) = -0.57 to -0.38], legal ( d = -0.20, 95% CI = -0.31 to -0.10) and psychiatric problems ( d = 0.29, 95% CI = -0.38 to -0.20) than TAU/Control. Sensitivity analyses indicated that Seeking Safety and STAGE 12 predominantly drove post-treatment improvements in family/social problems.

Conclusions: Substance use treatment may yield broader, delayed benefits beyond substance use reduction among Black adults in the United States. Compared with treatment-as-usual, social-contextual treatments can yield more sustainable effects in legal, family and psychiatric areas among Black adults, with interventions such as Seeking Safety and STAGE 12 showing particular benefits in addressing family-related challenges.

Related protocols: CTN-0125

This is the Primary Outcomes Article for CTN-0125.

Cocaine- and opioid-related overdose deaths have increased among Black people, which makes identifying effective treatments for Black people a high priority. We investigated the comparative effectiveness of behavioral treatments among Black adults who use cocaine and/or opioids.

Methods: Identified multisite randomized clinical trials (RCTs) of behavioral interventions that targeted substance use, had participants who self-identified as Black, and included cocaine use outcome measures from the National Drug Abuse Treatment Clinical Trials Network (CTN) datashare. We estimated cocaine use and opioid use severity scale scores while considering study-level measurement non-invariance. Then, we estimated the inverse probability of treatment-weighted (IPTW) linear mixed models to assess comparative effectiveness of treatments that address social-contextual factors and those focused solely on substance use (e.g., contingency management (CM)) relative to treatment-as-usual/controls on cocaine use and opioid use severity scores during- and post-treatment.

Results: Nine RCTs met inclusion criteria, with a combined sample of 1,381 Black adults who used cocaine and/or opioids. The IPTW linear mixed models indicated that cocaine use severity decreased from baseline to end-of-treatment across three treatment groups, with a greater decrease for social-contextual treatments and CM relative to treatment-as-usual/controls. However, this greater reduction was maintained at 12-month follow-ups for social-contextual treatments, while CM worsened relative to TAU/controls. We found decreases in latent opioid use severity with no or minor differences between treatment groups.

Conclusions: The findings suggest that addressing social-contextual factors is an essential treatment component for long-term reduction of cocaine use among Black adults.

Related protocols: CTN-0125

Objectives: Racial and ethnic differences in long-term outcomes associated with medications for opioid use disorder (MOUD) are poorly understood.

Methods: The present analyses were based on 751 participants with opioid use disorder (OUD) who were initially recruited from opioid treatment programs located in California, Connecticut, Oregon, Pennsylvania, and Washington and participated in a randomized controlled trial and at least one follow-up interview. 9.6% (n=72) of the participants self-identified as Non-Hispanic (NH) Black, 16.0% (n=120) Hispanic, and 74.4% (n=559) NH White. We tested racial and ethnic differences in psychiatric or social functioning, substance use and treatment participation.

Results: From the baseline to the end of follow-up interview, compared with NH White, Hispanic participants had a significantly greater proportion of months reporting any opioid use (45.5% vs. 32.5%, p<0.001) and a smaller proportion of months receiving any MOUD (47.7% vs. 58.1%; p<0.05), particularly receipt of buprenorphine treatment (8.3% vs. 14.9%; p<0.01). At the third follow-up interview, data from the Addiction Severity Index (ASI) indicated that Hispanic participants had greater severity in employment problems (0.72 vs. 0.58; p < 0.001), while Black participants had less severity in drug problems (0.11 vs. 0.16; p<0.05) compared to NH Whites.

Conclusions: The study found that Hispanic participants had higher rates of opioid use (heroin and prescription opioids), but few received MOUD (buprenorphine and methadone) during the follow-up period, which suggests that effective strategies are needed to increase access to MOUD among Hispanics. Additionally, addressing employment challenges might also help improve long-term outcomes for all populations with OUD.

Related protocols: CTN-0050

In the United States, one in 14 individuals experience a Substance Use Disorder (SUD). SAMHSA stated that in 2020, approximately 40 million individuals from ages 12 and above had a SUD (CDC, 2022 ; SAMHSA, 2021). There has been a 44% increase in overdose rates in Black communities between 1999 to 2023. One longitudinal study found that the opioid overdose fatality rate among “non-Hispanic Black men 55 years or older was 40.03 per 100,000 population, 4 times greater than the overall opioid overdose fatality rate of 10.70 per 100,000 for persons of the same age” (Mason, Soliman, Kim, & Post, 2022).

This poster describes CTN-0127, a pilot exploratory study that will pave the way for future initiatives focused on increasing SUD care in underserved Black communities through learning collaboratives (LC) between faith-based leaders (FBLs) and behavioral health providers (BHLs). An LC is a short-term (6- to 15-month) learning system that brings together teams (e.g., FBLs, community members, behavioral health/SUD, and social service providers) to seek improvement in a focused topic area.

Related protocols: CTN-0027

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. This study aimed 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.

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 (CTN-0027, START, CTN-0030, POATS, and CTN-0051, X:BOT). 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. THe main outcomes and measures were the maximum daily dose of buprenorphine or methadone received in each week for the first 4 weeks of treatment. The mean dose and percentage of patients receiving a higher dose (buprenorphine =16 mg and methadone =60 mg) were also compared across race and ethnicity groups.

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: 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.

Note: An invited commentary piece on this article was also published by JAMA Network Open (Schiff DM, Nidey N, Tiako MJN. Dosing inequities in opioid use disorder treatment trials. JAMA Network Open 2024;7(10):e2436582.)

Related protocols: CTN-0027, CTN-0030, CTN-0051

There has been a significant increase in methamphetamine use and methamphetamine use disorder (Meth UD) in the United States, with evolving racial and ethnic differences. This secondary analysis of data from CTN-0069 (ADAPT-2) explored racial and ethnic differences in baseline sociodemographic and clinical characteristics as well as treatment effects on a measure of substance use recovery, depression symptoms, and methamphetamine craving among participants in a pharmacotherapy trial for Meth UD.

The ADAPT-2 trial (ClinicalTrials.gov number, NCT03078075; N=403; 69% male) was a multisite, 12-week randomized, double-blind, trial that employed a two-stage sequential parallel design to evaluate the efficacy of combination naltrexone (NTX) and oral bupropion (BUP) vs. placebo for Meth UD. Treatment effect was calculated as the weighted mean change in outcomes in the NTX-BUP minus placebo group across the two stages of treatment.

Of the 403 participants in the ADAPT-2 trial, the majority (65%) reported non-Hispanic White, while 14%, 11% and 10% reported Hispanic, non-Hispanic Black, and non-Hispanic other racial and ethnic categories respectively. At baseline non-Hispanic Black participants reported less severe indicators of methamphetamine use than non-Hispanic White. Treatment effects for recovery, depression symptoms and methamphetamine cravings did not significantly differ by race and ethnicity.

Conclusions: Although we found racial and ethnic differences at baseline, our findings did not show racial and ethnic differences in treatment effects of NTX-BUP on recovery, depression symptoms and methamphetamine cravings. However, our findings also highlight the need to expand representation of racial and ethnic minority groups in future trials.

Related protocols: CTN-0068

As overdose rates rise among non-White Americans, understanding barriers to substance use disorder (SUD) treatment access by race and ethnicity is important. This study explores self-reported barriers to SUD treatment by race and ethnicity in emergency department (ED) populations.

We conducted a secondary, exploratory analysis of a randomized trial of patients not seeking SUD treatment who endorsed active drug use at six academic EDs (CTN-0047). Responses to the Barriers to Treatment Inventory were compared by race, ethnicity, and drug severity, using 2 tests (N = 858), followed by adjusted logistic regression models.

Absence of a perceived drug problem (39% non-Hispanic Black, 38% Hispanic, 50% non-Hispanic White; p = .001) was the most prevalent barrier to SUD treatment. Non-Hispanic Black participants were less likely to state that they could handle their drug use on their own (OR = 0.69, CI = 0.50-0.95), and were more likely to report disliking personal questions than non-Hispanic White participants (OR = 1.49, CI = 1.07-2.09). Non-Hispanic Black participants were less likely than Hispanic participants to agree that treatment availability (OR = 0.46, CI = 0.28-0.76) and family disapproval (OR = 0.38, CI = 0.16-0.91) were treatment barriers.

Conclusions: Screening and counseling may help address the barrier, common to all groups, that drug use was not seen as problematic. Expanding access to diverse treatment options may also address the range of barriers reported by our study population. This study is one of the first in the U.S. to examine both individual and structural barriers to accessing treatment and to examine the association with drug use severity by race/ethnicity.

Related protocols: CTN-0047

Recent data indicate rising opioid overdose deaths among African-American residents of Washington, DC. In this paper, researchers highlight a community-informed approach to assessing attitudes toward opioid use disorder (OUD) treatment among DC residents (February 2019 – March 2020). This paper is based on work conducted as part of CTN-0088.

A listening tour with trusted community leaders led to the formation of a Community Advisory Board (CAB). When the COVID-19 pandemic commenced in March 2020, community dialogues became exclusively virtual. The CAB partnered with academic leaders to co-create project mission and values and center the community’s concerns related to opioid use and its causes, treatment structure, and facilitators of effective engagement.

Interview guides were created for the engagement of community members, utilizing values highlighted by the CAB. The CAB underscored that in addition to opioid problems, effective engagement must address community experience, collective strengths/resilience, and the role of indigenous leadership.

Conclusions: Engaging community prior to project implementation and maintaining alignment with community values facilitated OUD assessments. Community-informed assessments may be critical to building community trust.

Related protocols: CTN-0088

The purpose of this study, part of NIDA-CTN-0117, was to examine changes in addiction medicine treatment utilization during the COVID-19 pandemic among adolescents (aged 13–17 years) and differences by race/ethnicity.

Researchers compared treatment initiation (overall and telehealth), engagement, and 12-week retention between insured adolescents with substance use problems during pre-COVID-19 (March to December 2019, n = 1,770) and COVID-19 (March to December 2020, n = 1,177) using electronic health record data from Kaiser Permanente Northern California.

Compared to pre-COVID-19, odds of treatment initiation, overall (adjusted odds ratio [95% confidence interval] = 1.42 [1.21–1.67]), and telehealth (5.98 [4.59–7.80]) were higher during COVID-19, but odds of engagement and retention did not significantly change. Depending on the outcome, Asian/Pacific Islander, Black, and Latino/Hispanic (vs. White) adolescents had lower treatment utilization across both periods. Changes in utilization over time did not differ by race/ethnicity.

Conclusions: Addiction medicine treatment initiation increased among insured adolescents during the pandemic, especially via telehealth. Although racial/ethnic disparities in treatment utilization persisted, they did not worsen.

Related protocols: CTN-0117

The objectives of this talk include 1) Describe the unique risk and protective factors
for substance use among Black adolescents; 2) Examine the evidence for culturally sensitive interventions for substance use prevention among Black adolescents; and
3) Identify opportunities for culturally tailored digital interventions for substance
use prevention among Black adolescents with a specific focus on family-based
interventions.

Addiction treatment rapidly transitioned to a primarily telehealth modality (telephone and video) during the COVID-19 pandemic, raising concerns about disparities in utilization. The objective of this study, part of CTN-0117, was to examine whether there were differences in overall and telehealth addiction treatment utilization after telehealth policy changes during the COVID-19 pandemic by age, race, ethnicity, and socioeconomic status.

This cohort study examined electronic health record and claims data from Kaiser Permanente Northern California for adults (age =18 years) with drug use problems before the COVID-19 pandemic (from March 1, 2019, to December 31, 2019) and during the early phase of the COVID-19 pandemic (March 1, 2020, to December 31, 2020; hereafter referred to as COVID-19 onset). Analyses were conducted between March 2021 and March 2023.

Generalized estimating equation models were fit to compare addiction treatment utilization during COVID-19 onset with that before the COVID-19 pandemic. Utilization measures included the Healthcare Effectiveness Data and Information Set of treatment initiation and engagement (including inpatient, outpatient, and telehealth encounters or receipt of medication for opioid use disorder [OUD]), 12-week retention (days in treatment), and OUD pharmacotherapy retention. Telehealth treatment initiation and engagement were also examined. Differences in changes in utilization by age group, race, ethnicity, and socioeconomic status (SES) were examined.

Among the 19 648 participants in the pre–COVID-19 cohort (58.5% male; mean [SD] age, 41.0 [17.5] years), 1.6% were American Indian or Alaska Native; 7.5%, Asian or Pacific Islander; 14.3%, Black; 20.8%, Latino or Hispanic; 53.4%, White; and 2.5%, unknown race. Among the 16 959 participants in the COVID-19 onset cohort (56.5% male; mean [SD] age, 38.9 [16.3] years), 1.6% were American Indian or Alaska Native; 7.4%, Asian or Pacific Islander; 14.6%, Black; 22.2%, Latino or Hispanic; 51.0%, White; and 3.2%, unknown race. Odds of overall treatment initiation increased from before the COVID-19 pandemic to COVID-19 onset for all age, race, ethnicity, and SES subgroups except for patients aged 50 years or older; patients aged 18 to 34 years had the greatest increases (adjusted odds ratio [aOR], 1.31; 95% CI, 1.22-1.40). Odds of telehealth treatment initiation increased for all patient subgroups without variation by race, ethnicity, or SES, although increases were greater for patients aged 18 to 34 years (aOR, 7.17; 95% CI, 6.24-8.24). Odds of overall treatment engagement increased (aOR, 1.13; 95% CI, 1.03-1.24) without variation by patient subgroups. Retention increased by 1.4 days (95% CI, 0.6-2.2 days), and OUD pharmacotherapy retention did not change (adjusted mean difference, -5.2 days; 95% CI, -12.7 to 2.4 days).

Conclusions: In this cohort study of insured adults with drug use problems, there were increases in overall and telehealth addiction treatment utilization after telehealth policies changed during the COVID-19 pandemic. There was no evidence that disparities were exacerbated, and younger adults may have particularly benefited from the transition to telehealth.

Related protocols: CTN-0117

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.

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.

Conclusions: 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 have the potential to substantially inform treatment approaches specifically designed for Black people who use psychostimulants.

Related protocols: CTN-0125

In this study, researchers sought to identify the sociodemographic and clinical characteristics associated with homelessness, and explore the relationship between homelessness and treatment outcomes among Black individuals. The study was a secondary analysis of the subgroup of Black participants (n=73) enrolled in “X:BOT,” a 24-week multisite randomized clinical trial comparing the effectiveness of extended-release naltrexone versus sublingual buprenorphine-naloxone (n=570). Outcomes included medication initiation, return to extramedical use of opioids assessed by both self-report and urine toxicology, and engagement in medications for opioid use disorder (MOUD) treatment at 28 weeks postrandomization. Descriptive statistics were performed.

Black participants were mostly unmarried and male, and about a third were aged 21–30 years. Among people experiencing homelessness, more were uninsured (45.5% [10/22] vs 19.6% [10/51]), unemployed (77.3% [17/22] vs 64.7% [33/51]), and reported alcohol (40.9% [9/22] vs 23.5% [12/51]) and sedative use (54.5% [12/22] vs 17.6% [9/51]) within the previous 30 days. Compared with housed Black individuals, a slightly higher proportion of Black individuals experiencing homelessness successfully initiated study medication (81.1% [18/22] vs 72.6% [37/51]); similar proportions returned to opioid use during the trial (68.2% [15/22] vs 68.6% [35/51]) and were engaged in MOUD at 28 weeks after trial entry (72.2% [13/18] vs 69.7% [23/33]) among participants located for follow-up.

Conclusions: These descriptive results among Black patients participating in a trial of MOUD suggest that efficacious MOUD is possible despite homelessness with additional clinical supports such as those provided by a clinical trial.

Related protocols: CTN-0051

Black women are at heightened risk for trauma exposure, post-traumatic stress disorder (PTSD), and substance use disorders (SUDs) compared to white women and the general population. However, disparities in treatment engagement and retention persist, particularly for Black women with co-occurring PTSD and SUD. Although therapeutic alliance is an important predictor and mediator of treatment retention and outcomes, we know little about predictors of alliance and the mediating role of alliance for PTSD+SUD outcomes among Black women.

This study used data previously collected for the National Drug Abuse Treatment Clinical Trials Network (CTN) Women and Trauma Study (CTN-0015), which compared Seeking Safety (a cognitive-behavioral intervention for PTSD+SUD) to Women’s Health Education (control). It includes 88 Black/African American women from both arms of the original trial. Measures included the Helping Alliance Questionnaire, Addiction Severity Index-Lite, and Clinician Administered PTSD Scale. Women in the intervention arm also completed the Seeking Safety Feedback Questionnaire.

Stepwise, hierarchical linear regressions indicted that years of education and previous alcohol/drug treatment attempts significantly predicted early alliance in the second week of therapy, but not late alliance in the last week of therapy. Greater education and more treatment attempts were associated with higher early alliance. Alliance did not mediate relationships between these significant predictors and treatment outcomes (e.g., attendance, post-treatment PTSD and SUD symptoms) or treatment feedback in the Seeking Safety group.

Conclusions: Education and prior treatment attempts predicted early alliance among Black/African American women in PTSD+SUD group treatment, and higher education level was associated with poorer Seeking Safety feedback topic ratings. Educational level and treatment history should be considered during alliance building in therapeutic interventions with Black women. Clinicians may consider the integration of pre-treatment alliance-building strategies with Black female patients who have lower levels of education. This study provides insight into the relative impact of several important factors that influence early alliance among Black women with co-occurring PTSD and SUD.

Related protocols: CTN-0015