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This is the primary outcomes paper for CTN-0133.
Background: Underrepresented communities in the Southwestern United States Borderlands region face disproportionate substance use disorder (SUD) burdens yet remain largely excluded from clinical trials. No existing resource integrates health beliefs, research literacy, and vulnerability frameworks to support diverse community engagement in SUD clinical trials.
Methods: We developed the Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials (EXPLORE) Toolkit through a multi-phase process (2021-2024) including systematic review of existing toolkits, domain development, platform design, individual interviews (n = 10), and two rounds of theater testing with community health workers serving Hispanic communities in Southern New Mexico (n = 60) and American Indian communities in Northern New Mexico (n = 25). Pre/post surveys assessed feasibility, acceptability, community interest, and research literacy. Ripple Effects Mapping evaluated the development process.
Results: Domain-specific toolkit importance ratings averaged 4.48-4.61 on a 5-point scale; 79% of participants rated the toolkit “very important” for promoting culturally competent research, and 64% were “very likely” to recommend it. Post-theater testing scores improved for perceived feasibility of conducting clinical research in participants’ communities (pre: 7.19 vs. post: 7.94, 10-point scale) and research terminology understanding (pre: 7.97 vs. post: 8.74). Qualitative themes included cultural appropriateness, the role of community gatekeepers, and confidentiality concerns in rural and border communities.
Conclusions: The EXPLORE Toolkit demonstrates promise for bridging researcher-community gaps in SUD clinical trials. Findings highlight the value of interdisciplinary, community-centered development and the need for ongoing cultural adaptation.
Find the EXPLORE Toolkit here!
Related protocols: CTN-0133
Dr. Korthuis reviewed the biological basis of medications for OUD, presented recent data on the effects of buprenorphine on patient outcomes, and introduced tools for integrating buprenorphine treatment into your current setting.
This webinar, sponsored by the Northwest ATTC and the Western States Node of the NIDA CTN, summarized what makes women’s treatment for substance use disorder (SUD) unique from men’s treatment and highlighted key issues when providing treatment to pregnant and parenting women with opioid use and other SUDs.
Peer recovery support services are supports provided across the service continuum by credentialed individuals in long-term recovery from alcohol or other drug-related problems. Peer recovery support specialists serving people following release from jails and prisons have a unique responsibility to support community reentry and adherence to community corrections requirements. They may also facilitate entry into treatment post-release and support engagement in recovery services in the months following incarceration. This webinar described the unique role of peer support specialists in the CDC-funded pilot project Reducing Overdose After Release from Incarceration (ROAR). The ROAR pilot combines provision of medication for opioid use disorder with support from Oregon Certified Recovery Mentors (CRMs) to reduce overdose risk among women released from prison.
In this session, John Kelly, PhD, ABPP of Harvard University discussed the fundamental causes of stigma in relation to substance use disorder, reviewed some of the paradoxical findings from the latest stigma research, and suggested how stigma might be more systematically addressed to enhance the clinical care and outcomes of individuals suffering from substance use disorder.
The goal of the National Institute of Drug Abuse (NIDA) Clinical Trials Network/Addiction Technology Transfer Center (ATTC) webinar series is to help scholars and clinicians in the addiction field stay abreast of cutting edge science. In this webinar, Keith Humphreys, PhD (Stanford University) explored the landscape of mutual help groups and the diverse mutual help groups that are available to patients. The clinical and cost effectiveness of group and 12-step programs were reviewed, as well as the clinical and policy implications of mutual help groups for promoting recovery from addiction.
Background: Cannabis is the most commonly used drug in the United States, and among people who use cannabis, polysubstance use is common and understudied. We aimed to examine the association of tetrahydrocannabinol (THC) positive urine drug screen (+UDS) with the odds of submitting a cocaine + UDS during cocaine use disorder treatment.
Methods: We conducted a secondary data analysis of a previously reported double-blind, placebo-controlled clinical trial, CTN0048. Participants meeting criteria for opioid abuse/dependence were assigned to receive extended-release naltrexone and one of three conditions of buprenorphine (placebo, 4 mg/day, 16 mg/day) for 8 weeks. Generalized estimating equations (GEE) were used to analyze urine samples (Liu et al., 2018) collected over time, examining the association between THC + UDS and cocaine + UDS during treatment.
Results: Participants (n = 301) averaged 46 (SD = 8.64) years of age, were majority male (78.41 %), non-Hispanic (89.70 %), and African American (66.45 %). GEE results indicated that patients who submitted THC + UDS had significantly higher odds of submitting cocaine + UDS compared to participants who submitted THC-negative UDS across the 25 time points examined (OR = 1.47, 95 % CI = 1.21–1.79, p = 0.00). Time (OR = 0.9998, 95 % CI: 0.9997, 0.9999, p = 0.018) and the covariate of sex assigned at birth (OR = 1.77, 95 % CI = 1.13–2.77, p = 0.013) were also significant in the model, indicating very small decreases in the odds of submitting a cocaine + UDS over time for all patients and 77 % higher odds of submitting cocaine + UDS for females.
Conclusion: THC + UDS was associated with increased odds of submitting a cocaine + UDS during treatment. Further investigation is needed to discern whether decreasing THC use will result in reduced cocaine use; however, these results suggest that it may be beneficial to counsel patients on cannabis use cessation both before and during treatment for cocaine use, as it is related to cocaine use treatment outcomes.
Related protocols: CTN-0048
Background: This study examined sexual delay discounting (SDD) as a potential factor associated with the relationship between substance use and condomless anal sex (CAS) among Black and Latino men who have sex with men (MSM).
Methods: Baseline data were drawn from a multi-site HIV testing promotion trial (NIDA-CTN-0083) involving Black and Latino MSM across eight U.S. states and the District of Columbia. Past 90-day CAS and past 12-month substance use were assessed via self-report. SDD was measured using the Sexual Delay Discounting Task and summarized as area under the curve (AUC) values. K-means clustering identified four SDD profiles: high self-control, globally impulsive, immediate-impulsive, and delayed-impulsive. Ordinal logistic regression models examined associations among substance use, SDD profiles, and CAS.
Results: A total of 271 participants were included. Compared with the high self-control group, the odds of CAS were significantly higher among the delayed-impulsive (OR = 2.978, p = 0.001), immediate-impulsive (OR = 8.970, p < 0.001), and globally high-discounting groups (OR = 9.427, p < 0.001). Alcohol and illicit drug use were modeled separately. Although substance use showed no overall main effect, significant interactions indicated that illicit drug use was more strongly associated with CAS among immediate-impulsive (OR = 1.485, p = 0.039) and globally high-discounting participants (OR = 1.686, p = 0.004).
Conclusions: SDD profiles were associated with CAS and may shape how illicit drug use relates to sexual risk behavior among Black and Latino MSM. These findings highlight the importance of considering temporal impulsivity in HIV prevention efforts.
Related protocols: CTN-0083
American Indian and Alaska Native (AI/AN) communities experience a disproportionate burden of substance use disorders (SUDs) alongside persistent barriers to culturally responsive care and research participation. Despite this need, AI/AN populations remain underrepresented in substance use research, in part due to historical and ongoing systemic inequities, including research practices that have not adequately respected Tribal sovereignty or incorporated Indigenous knowledge systems. This commentary synthesizes research conducted within the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) focused on AI/AN communities, identifies key lessons learned from this body of work, and offers recommendations for future research.
First, we provide an overview of CTN-supported studies involving AI/AN populations, highlighting both the diversity of substance use patterns across communities and the feasibility of conducting rigorous, culturally responsive research. Second, we synthesize lessons learned from these studies and related literature, including the importance of long-term relationship building, the need for culturally responsive research frameworks, structural barriers to implementation, and workforce and infrastructure challenges. Third, we present recommendations for the field, emphasizing the central role of community-based participatory research (CBPR) and Tribal participatory research (TPR), the integration of Indigenous knowledge systems, and the importance of Tribal data sovereignty and community-led dissemination.
Collectively, this commentary argues that sustainable progress in addressing SUDs among AI/AN populations requires a fundamental shift toward community-engaged, culturally responsive, and equity-focused research partnerships. The experiences of the CTN AI/AN Special Interest Group demonstrate that such approaches are not only feasible but essential for advancing both scientific knowledge and community health.
Related protocols: CTN-0020-A-1, CTN-0033-Ot-1, CTN-0033-Ot-2, CTN-0033-Ot-3, CTN-0033-Ot-4, CTN-0033-Ot-5, CTN-0044-A2, CTN-0078-Ot, CTN-0096, CTN-0096-A-1, CTN-0118, CTN-0123, CTN-0129
This webinar provided an interactive learning experience for attendees to explore adolescent substance use and new paths for research. Presenter Niranjan Karnik, MD, PhD, director of the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN) Great Lakes Node, reviewed recent data trends related to the prevalence of substance use among teens, described current treatment approaches, and talked about the pros and cons of social media and digital mental health interventions.
In this webinar co-hosted by the CTN Western States Node, Natania Crane, PhD, provides current information on research and treatment related to cannabis use and mental health, including recent changes in cannabis use, how the endocannabinoid system may regulate mental health symptoms, and what we currently know about cannabis use and mental health.
In this session, Drs. Rossom and Hooker discussed the design and implementation of Opioid Wizard, a clinical decision support tool embedded in the EHR for primary care clinicians and developed as part of NIDA Clinical Trials Network protocol CTN-0095. The goal of the tool is to help clinicians identify, screen, diagnose and treat opioid use disorder (OUD).
They also discussed one of the supplements to CTN-0095, which tested a training to reduce stigma towards people with OUD among primary care clinicians.
Related protocols: CTN-0095
In this session, Kathleen T. Brady, MD, PhD, of the Medical University of South Carolina, will discuss the NIDA Clinical Trials Network (CTN) study CTN-0108, “Transcranial Magnetic Stimulation for the Treatment of Methamphetamine/Cocaine Use Disorder,” a pilot study that aims to determine the feasibility, effectiveness, and safety for 20 sessions of repetitive transcranial magnetic stimulation (rTMS) versus sham in adults with a diagnosed methamphetamine or cocaine use disorder. Dr. Brady, co-Principal Investigator for CTN-0108, presented the rationale for the study, including the literature supporting the use of rTMS in stimulant use disorder, as well as the study methodology and preliminary results.
Related protocols: CTN-0108
This presentation from Noel Vest, PhD, Assistant Professor at Boston University School of Public Health, explored findings from a mixed-methods national study examining the structure, implementation, and impact of Collegiate Recovery Programs (CRPs) in the U.S. and Canada.
In this webinar, Erin Winstanley, PhD (University of Pittsburgh and West Virginia University, CTN Appalachian Node), described a NIDA Clinical Trials Network study, CTN-0135, examining clinician-reported challenges with initiating buprenorphine for people using fentanyl, including precipitated or prolonged withdrawal, patient reports that buprenorphine was ineffective, and patient preference for methadone. In response to these challenges, most clinicians surveyed reported modifying their standard induction protocols or patient counseling approaches. Clinicians treating larger patient volumes, seeing a high proportion of patients using fentanyl, or initiating treatment in non-inpatient settings were more likely to report difficulties starting patients on buprenorphine.
Related protocols: CTN-0135