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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

This is the primary outcomes paper for CTN-0101.

Background and aims:
Individuals who engage in illicit or nonmedical opioid use may have elevated risk of health and social consequences, including progression to opioid use disorder (OUD). Preventive interventions to reduce this risk are lacking. This trial tested the impact of a primary care-integrated collaborative care approach for reducing risky opioid use, defined as nonmedical use of prescription opioids or any use of illicit opioids.

Design: Cluster-randomized controlled trial randomized primary care providers (PCPs) and their patients into the Subthreshold Opioid Use Disorder Prevention (STOP) intervention or enhanced usual care (EUC).

Setting: Primary care clinics at 5 U.S. sites.

Participants:
PCPs and their patients were recruited January 2021–May 2023. A total of 119 PCP clusters (STOP=48, EUC=51) and 202 patients (STOP=88, EUC=114) enrolled. Eligible patients were adults (≥18 years) having current risky opioid use, without moderate–severe OUD. Patient participants were majority female (63.4%), white (70.8%) and non-Hispanic (96.5%), with a mean age of 55.7 [standard deviation (SD) = 12.7] years. At baseline, 63.4% of participants had moderate–severe pain (Brief Pain Inventory) and below average physical (79.2%) and mental (62.4%) health (SF-12).

Interventions: The STOP collaborative care intervention consisted of brief advice from the PCP about reducing risky opioid use, meetings with a clinic-embedded nurse care manager over 12 months and remote health coaching (2–6 sessions). Both groups received primary care treatment as usual and overdose risk reduction materials.

Measurements: The primary outcome was total days of risky opioid use, recorded from 6 monthly electronic surveys. A key secondary outcome was moderate–severe OUD at 6 and 12 months.

Findings: A total of 77 (87.5%) STOP and 107 (93.9%) EUC participants completed the 6-month assessment period. The primary outcome analysis used the Intention-to-Treat sample with multiple imputations of missing data. Mean days of risky opioid use at 180 days were lower in STOP than EUC [12.2 (SD = 27.73) vs. 15.5 (SD = 32.64)]; the difference between groups adjusted for baseline risky opioid use was not statistically significant (rate ratio 0.95, 95% confidence interval = 0.52–1.74). One STOP participant (1.1%) and 13 EUC participants (11.4%) developed moderate–severe OUD at 6 months, and 3 (3.4%) STOP and 6 (5.3%) EUC participants had moderate–severe OUD at 12 months (P<0.001).

Conclusions: This cluster-randomized controlled trial did not find evidence that the STOP intervention for reducing risky opioid use produced greater reductions over 6 months compared with enhanced usual care, though fewer intervention participants progressed to moderate–severe opioid use disorder. Patients had a high burden of pain and comorbidities that may present challenges to reducing opioid use.

Related protocols: CTN-0101

This is the Primary Outcomes Article for CTN-0130.

Fentanyl-related, cocaine-overdose deaths have drastically increased, yet research on how people who use cocaine perceive fentanyl adulteration is limited. This study developed the novel Adulterated Cocaine Purchasing Task, a modification of the original Cocaine Purchasing Task, to quantify how people respond to fentanyl adulteration in cocaine.

In the Adulterated Cocaine Purchasing Task, participants indicated how much cocaine they would purchase when cocaine had no (0%) versus some (10%) probability of fentanyl adulteration. Study aims were to (a) determine how possible fentanyl adulteration affects cocaine demand and (b) determine which individual characteristics predict continued demand for cocaine despite fentanyl adulteration.

This Amazon Mechanical Turk study included self-reported cocaine purchasers (N = 64), who completed self-report questionnaires (demographics, substance use history, depression/posttraumatic stress disorder symptoms, fentanyl knowledge quiz), and the Adulterated Cocaine Purchasing Task.

Results showed (a) that a greater probability of fentanyl adulteration (10%) lowered cocaine demand, but only for intensity (Q₀; amount of cocaine consumed when free; p < .001); (b) no effect on other demand indices (Omax, Pmax, essential value, breakpoint); (c) significantly more zero responders with 10% probability of fentanyl adulteration than 0%, p < .001; and (d) that opioid co-use, depression, age, posttraumatic stress disorder, fentanyl knowledge, and cocaine use severity did not moderate the relationship between fentanyl adulteration and intensity.

Conclusions: Overall, fentanyl adulteration reduced cocaine demand but only for volume preferred at minimal cost, not general motivational drive for use, illustrating the dangerous insensitivity to toxic contamination. The internal validity of the paradigm provides proof-of-concept for this approach to identify individuals at risk from fentanyl-adulterated cocaine.

Related protocols: CTN-0130

This is the primary outcomes article for CTN-0080. Importance: Treating opioid use disorder (OUD) in pregnancy with sublingual buprenorphine is an evidence-based practice, but it has disadvantages that could be addressed with an extended-release formulation.

Objective: To evaluate the effectiveness and safety of extended-release buprenorphine vs sublingual buprenorphine for OUD in pregnancy through 12 months post partum.

Design, setting, and participants: This 2-group, open-label, noninferiority, randomized clinical trial was conducted between July 2, 2020, and October 30, 2024, among adults with OUD and a singleton pregnancy of 6 to 30 weeks’ gestational age at 13 outpatient cross-disciplinary peripartum OUD treatment sites.

Interventions: Randomization to sublingual or extended-release buprenorphine (weekly formulation during pregnancy, monthly formulation optional post partum if not breastfeeding).

Main outcomes and measures: The primary and key secondary outcomes were illicit opioid abstinence during pregnancy and the postpartum period, respectively, defined as the proportion of weekly collected urine samples negative for illicit opioids. If noninferiority was demonstrated at a margin of 0.15, testing for superiority was planned. Key secondary infant outcomes from medical records were opioid treatment for neonatal opioid withdrawal syndrome (NOWS; yes or no) and number of opioid treatment days for NOWS.

Results: Among 140 randomized participants, the mean (SD) age was 31.2 (4.6) years. There were 10 Black participants (7.1%), 10 Hispanic participants (7.1%), 116 (82.9%) White participants, and 14 participants (10.0%) who belonged to additional groups. All but 2 were already prescribed sublingual buprenorphine. Study completion was 98% through pregnancy (137 participants) and 81% through 12 months post partum (114 participants). Illicit opioid abstinence was higher during pregnancy for participants receiving extended-release vs sublingual buprenorphine (82.5% vs 72.6%; mean difference, 9.84 [95% CI, 1.72 to 17.95] percentage points; P = .009). Postpartum abstinence rates declined and were similar in both groups (60.2% vs 59.5%; mean difference, 0.65 [98% CI, -12.72 to 14.02] percentage points; P = .45). Those receiving extended-release buprenorphine experienced fewer serious adverse events during pregnancy (8.7% vs 26.8%; P = .007) and post partum (6.0% vs 18.6%; P = .04). Nonserious adverse events rates did not differ between groups, but more were deemed medication-related for extended-release participants during pregnancy (26.1% vs 7.0%; P = .003). Infants exposed to extended-release vs sublingual buprenorphine did not differ in need for opioid treatment (30.2% vs 26.5%; relative risk, 1.14 [98% CI, 0.54 to 1.99]; P = .64) or mean (SE) treatment days (10.9 [2.2] vs 14.8 [3.0] days; relative risk, 0.73 [98% CI, 0.36 to 1.51]; P = .28). At birth, extended-release-exposed neonates had larger mean (SE) head circumferences than those exposed to sublingual buprenorphine (34.0 [0.2] vs 33.4 [0.2] cm; mean difference, 0.63 [95% CI, -0.00 to 1.26] cm; P = .049).

Conclusions and relevance: The findings of this randomized clinical trial support weekly extended-release buprenorphine for OUD treatment during pregnancy.

Related protocols: CTN-0080

This is the primary outcomes article for CTN-0099.

Importance: Extended-release injectable buprenorphine may expand the reach of initiating medications for opioid use disorder in high-risk and hard-to-reach individuals who visit the emergency department (ED) and can be administered in low levels of withdrawal.

Objective: To compare the effect of ED-initiated 7-day extended-release injectable buprenorphine vs sublingual buprenorphine on treatment engagement at 7 days.

Design, Setting, and Participants: Multicenter randomized clinical trial enrolling adult patients presenting to the ED with untreated opioid use disorder and a Clinical Opiate Withdrawal Scale (COWS) score of 4 or higher across 29 EDs in the US from July 12, 2020, to August 21, 2024. Final follow-up was completed on October 24, 2024.

Interventions: Patients were randomized to receive a 24-mg injection of extended-release buprenorphine (equivalent to 16 mg/d) or sublingual buprenorphine, which included either self-administration instructions if the COWS score was less than 8 or administration of 8 mg of sublingual buprenorphine in the ED if the COWS score was 8 or higher. All sublingual buprenorphine group patients received a 7-day prescription for 16 mg/d. Both groups were provided referral for ongoing medication with a scheduled appointment within 7 days.

Main Outcomes and Measures: Engagement in opioid use disorder treatment on day 7 was the primary outcome. Secondary outcomes included engagement at 30 days, precipitated withdrawal and overdose events, craving scores, days of illicit opioid use, and patient satisfaction with treatment.

Results: Among 2000 patients randomized, 6 who were enrolled twice were excluded, resulting in 991 in the extended-release group and 1003 in the sublingual group. The median age was 37 (IQR, 30-47) years, 68% were male, 31% had an initial COWS score of 4 to 7, and 76% tested positive for fentanyl. The adjusted proportion of engagement in opioid use disorder treatment at 7 days was 40.5% with extended-release buprenorphine vs 38.5% with sublingual buprenorphine (adjusted difference, 1.6%; 95% CI, −2.8% to 6.0%). Engagement at 30 days was similar, with adjusted proportions of 43.8% with extended-release buprenorphine vs 44.9% with sublingual buprenorphine (adjusted difference, −1.5%; 95% CI, −6.2% to 3.2%). Precipitated withdrawal was rare: 6 (0.6%) with extended-release buprenorphine and 8 (0.8%) with sublingual buprenorphine. Overdose events within 30 days occurred in 18 participants (2.3%) in each group. Patients receiving extended-release buprenorphine reported lower mean craving scores at 7 days vs those receiving sublingual buprenorphine (scale, 0-100; mean score, 26.5 vs 30.2, respectively; adjusted mean difference, −3.85; 95% CI, −7.08 to −0.63), fewer days of illicit opioid use in the past 7 days (adjusted ratio of means, 0.77; 95% CI, 0.68-0.95), and better treatment satisfaction scores (scale, 1-5; adjusted mean difference, 0.13; 95% CI, 0.01-0.25).

Conclusions and Relevance: No difference was detected in opioid use disorder treatment engagement on day 7 between the 7-day extended-release and sublingual buprenorphine groups. Both buprenorphine formulations were well tolerated; precipitated withdrawal was rare despite a high prevalence of fentanyl.

Related editorial: Moe J, et al. Buprenorphine in the ED — Balancing access, safety, and autonomy. JAMA 2026 (in press).

Related protocols: CTN-0099

This is the primary outcomes paper for Aim 2 of CTN-0129.

Purpose: Addressing substance use disorders remains a high priority for many Indigenous communities. Opioid misuse and deaths related to overdose have been increasing sharply in American Indian/Alaska Native populations. Medications for opioid use disorder (MOUD) remain difficult to access in Great Plains Tribal Communities due to the paucity of treatment providers, among other factors. The present study explores the perceived barriers and facilitators to using telehealth to promote access to MOUD and recovery resources in Great Plains Tribal Communities.

Methods: This study employed qualitative methods to review policy considerations for using telemedicine to provide buprenorphine. We obtained qualitative data from 5 interviews with 8 total key informants (62.5% women, 25% with tribal affiliations) with local administrators, health care providers, and policymakers. Their responses were transcribed and coded with NVivo software.

Findings: After coding and analysis, 6 themes emerged: current access, acceptability in Tribal Communities, facilitators, barriers, payment considerations, and policies that support tele-MOUD. Participant responses—though specific to Great Plains Tribal Communities—mirrored other recommendations on telemedicine and substance use disorder services such as federal support of reciprocity of state licenses, permanent codification of the regulatory changes enacted during the COVID-19 public health emergency, increased funding for innovative delivery of services, and considerations of privacy; the need for culture- and trauma-informed providers was also noted.

Conclusions: Telemedicine for the provision of MOUD appears, from this qualitative analysis, to be a feasible way to expand access to care for opioid use disorder in Great Plains Tribal Communities.

Related protocols: CTN-0129

This is the primary outcomes article for Aim 1 of CTN-0129.

Substance use, specifically opioid and methamphetamine use, is of increasing concern among American Indian (AI) populations in the Great Plains. This community-driven participatory study investigated the impacts of substance use and community-defined needs in treating addiction. It determined the priorities for future research on behavioral health and substance misuse in the Great Plains region. Behavioral health and social services professionals and community stakeholders were identified from eight Great Plains communities and invited to attend eight focus groups (N=47). Conversations were audio-recorded, transcribed, and coded by the research team.

The qualitative data analysis identified four themes: (1) Challenges with Treatment and Recovery, (2) Impact of Substance Use, (3) Reasons for Substance Use, (4) Solutions and Research Priorities.

The findings highlight barriers to substance use disorder (SUD) treatment ranging from policy issues to lack of funding. The most significant finding centered on integrating cultural strengths into treatment and recovery programs, including Ceremony Assisted Treatment (CAT). Data reports for each participating organization were provided to disseminate outcomes in their respective communities. Other key findings suggest that addressing the root causes of substance use disorder, along with early intervention and comprehensive counseling services, are essential for long-term success.

Related protocols: CTN-0129

This is the primary outcomes article for CTN-0135.

Importance: Anecdotal accounts suggest an increase in problems initiating buprenorphine (BUP) treatment among individuals using illicitly manufactured fentanyl. Limited empirical data illuminate these challenges.

Objective: To determine the prevalence of clinician-reported problems initiating BUP treatment among patients using fentanyl and describe clinical strategies used to overcome engagement challenges.

Design, setting, and participants: For this survey study, an online survey was pilot tested and refined with a convenience sample of physicians. The final survey included 96 items and took less than 15 minutes to complete. The survey queried patients’ use of fentanyl, BUP induction problems (precipitated or prolonged withdrawal), strategies to overcome induction problems, clinician characteristics, and practice characteristics. Eligible clinicians initiated BUP for at least 10 patients with opioid use disorder in the past year and at least 1 patient in the past 90 days. The survey was live from June 2, 2023, to March 18, 2024.

Main outcome and measures: The main outcome of interest was precipitated and/or prolonged opioid withdrawal. Descriptive statistics are reported, and logistic regression was used to identify factors associated with BUP initiation problems.

Results: A random sample of physicians and advanced practice clinicians in the US Drug Enforcement Administration (DEA) registrant dataset from October 2022 (n = 3141) were invited to participate; of 2485 eligible for inclusion, 649 (26.1%) completed the prescreen survey. Of 421 (64.9%) eligible to complete the survey, the final sample included 396 (94.1%) clinicians who completed at least 50% of the survey items. Of 390 participants, 284 (72.8%) reported problems when initiating BUP in patients using fentanyl, with 242 of 394 (61.4%) reporting patients’ experiencing precipitated withdrawal. A total of 264 or 392 participants (67.3%) reported modifying their standard induction procedures, changing how they counsel patients, or changing both medication and counseling protocols. In multivariable modeling, clinicians were more likely to report problems initiating BUP in patients if they had a DEA waiver to treat more than 100 patients (OR, 1.92; 95% CI, 1.08-3.40), vs those waivered to treat fewer patients; if they reported at least 75% of their patients using fentanyl (OR, 6.31; 95% CI, 2.59-15.35), vs no patients; or if they inducted patients in noninpatient settings (OR, 2.79; 95% CI, 1.39-5.61), vs inpatient settings.

Conclusions and relevance: In this survey study of clinician-reported problems initiating BUP treatment, clinicians working in high-volume noninpatient settings reported more problems initiating BUP in patients using fentanyl, and many reported changing their clinical practices in response to these problems. Further research is warranted to match alternate BUP induction strategies by clinical settings.

Related protocols: CTN-0135

This is the primary outcomes article for CTN-0095.

Nearly 727,000 individuals in the US died of opioid overdoses between 1999 and 2022. The current workforce of addiction medicine specialists is inadequate to address the scale of this crisis, and primary care clinicians (PCCs) do not feel sufficiently supported to treat opioid use disorder (OUD).

Objective: To evaluate whether an electronic health record–integrated clinical decision support system (CDSS) increases OUD diagnosis and treatment in primary care.

Design, Setting, and Participants: This pragmatic cluster randomized clinical trial was conducted from April 2021 to December 2023. Primary care clinics in 3 health systems in 4 US states were randomized to receive or not receive an electronic health record–integrated CDSS aimed at improving OUD diagnosis and treatment. Eligible patients were aged 18 to 75 years, visited a randomized clinic, and had an OUD diagnosis in the last 2 years, opioid overdose in the last 6 months, or risk score indicating high risk of OUD or opioid overdose. Data were analyzed from September 2023 to October 2024.

Interventions: The OUD CDSS provided personalized treatment recommendations to patients and PCCs in intervention clinics.

Main Outcomes and Measures: Primary outcomes were likelihood to receive (1) an OUD diagnosis (among high-risk patients without a baseline OUD diagnosis), (2) a naloxone prescription, or (3) a prescription of a medication for OUD (MOUD) or specialty referral, all within 30 days of first eligible (index) visit, and (4) days covered by a MOUD prescription in the 90 days after index.

Results: Among 10,891 patients meeting eligibility criteria, 5918 (54.3%) were female, and the mean (SD) age was 48.0 (13.9) years. There was no difference in OUD diagnoses within 30 days between groups. Patients in the intervention group had more naloxone orders (80 of 5538 [1.4%] vs 40 of 5353 [0.7%]; odds ratio, 1.76; 95% CI, 1.14-2.72) and orders for MOUDs or treatment referral (775 of 5538 [14.0%] vs 503 of 5353 [9.4%]; odds ratio, 1.48; 95% CI, 1.05-2.08) within 30 days. There were no differences in median (IQR) days covered by MOUD over 90 days postindex between intervention (84 [55-90] days) and usual care (83 [55-90] days; rate ratio, 1.00; 95% CI, 0.93-1.08) or in overdose or death rates during the intervention period.

Conclusions and Relevance: In this cluster randomized clinical trial, the intervention improved rates of naloxone orders and OUD treatment in primary care but did not affect days covered by a MOUD over 90 days postindex or overdose or death rates. These findings demonstrate an OUD CDSS can help increase access to OUD treatment in primary care.

Related protocols: CTN-0095

This is the primary outcomes article for CTN-0150.

Overdose is a leading cause of pregnancy-associated mortality in the US. Our personally-tailored opioid-overdose (OOD) and medication for opioid use disorder (MOUD) education intervention has been shown to significantly improve MOUD/OOD knowledge in out-of-treatment persons using illicit opioids. We evaluated the ability of the intervention modified for peripartum (pregnant or within one year postpartum) individuals, the personally-tailored OOD and MOUD education (TOME) intervention, to increase MOUD (primary) and OOD (key secondary) knowledge.

Methods: A six-site, two-arm, open-label, trial with 131 peripartum individuals receiving MOUD (methadone or buprenorphine) randomized to TOME, a 15-minute, computer-facilitated, individually-tailored intervention, or Control. TOME participants received education on MOUD and OOD questions they missed in a pre-test. Control participants received SAMHSA handouts on OOD and MOUD. All participants were scheduled for a 3-week post-test.

Results: Participants were enrolled in MOUD for an average of 15.6 months (SD=20.4) at baseline, with 30.5% enrolled in methadone and 69.5% enrolled in buprenorphine treatment. On the pre-test, participants answered 66.7% of the MOUD and 82.1% of the OOD questions correctly on average. Linear regressions indicated that participants’ MOUD (X2=33.96, p<0.001) and OOD (X2=45.78, p<0.001) knowledge increased significantly more in the TOME, relative to Control, group.

Conclusions: In a sample of peripartum patients enrolled in MOUD for a substantial length of time, TOME significantly increased MOUD and OOD knowledge. Taken together with past research, these findings suggest that there are gaps in MOUD and OOD knowledge in individuals with opioid use disorder that can be addressed with brief personally-tailored education.

Related protocols: CTN-0150

This is one of the primary outcomes articles for CTN-0082.

In Southern U.S. states with high HIV incidence and low HIV Pre-Exposure Prophylaxis (PrEP) uptake, enhanced efforts to increase interest in and willingness to use PrEP are needed. This implementation survey examined the associations of sociodemographic background, substance use, and sexual risk behaviors with willingness to use daily oral and long-acting injectable (LAI) PrEP among substance using men who have sex with men (SU-MSM). Participants were 225 SU-MSM recruited from sexually transmitted infection (STI) clinics, syringe services programs (SSPs), and substance use treatment programs (SUTPs) in eight Southern U.S. cities. Rates of willingness were high for both daily oral PrEP (78%) and LAI PrEP (66%). In multivariable analyses, distinct factors were associated with willingness towards each. For daily oral PrEP, greater willingness was associated with condomless anal sex, less frequent non-injection opioid use, prior PrEP awareness, and past use of PrEP. For LAI PrEP, greater willingness was associated with Black race, identifying as gay, being single, and higher injection drug use frequency. Lower willingness to use LAI PrEP was associated with higher non-injection opioid use frequency. Findings about willingness to use LAI PrEP, as a relatively newer modality, and greater willingness among Black SU-MSM as a disproportionately HIV-impacted population, are especially important.

Conclusions: These findings argue for the necessity to enhance PrEP promotion efforts that distinguish between oral and LAI PrEP and that are specifically tailored to major SU-MSM subgroups in the Southern U.S.

Related protocols: CTN-0082

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

The effectiveness of motivational enhancement therapy (MET) in comparison with counseling as usual (CAU) for increasing retention and reducing substance use was evaluated in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0004, a multisite randomized clinical trial. Participants were 461 outpatients treated by 31 therapists within 1 of 5 outpatient substance abuse programs. Contrary to the study hypothesis, MET did not appear to be more effective than CAU for either retention measure or urine drug outcome. However, though both 3-session interventions resulted in reductions in substance use during the 4-week therapy phase, MET resulted in sustained reductions during the subsequent 12 weeks whereas CAU was associated with significant increases in substance use over this follow-up period. MET also resulted in more sustained substance use reductions than CAU among primary alcohol users, but no difference was found for primary drug users. An independent evaluation of session audiotapes indicated that MET and CAU were highly and comparably discriminable across sites. Although the researchers did not directly assess the efficacy of their training model, the results of this study and its companion single-session protocol (Carroll et al, 2006) indicated that community-based therapists can learn to deliver MET effectively even in the absence of a priori allegiance, interest, or training in the model. Future analyses will evaluate the relationship between therapist experience, skill, adherence, and treatment outcomes.

This is the primary outcomes paper for CTN-0124.

This paper aims to address the challenges in providing adequate access to Medications for Opioid Use Disorder (MOUDs) within underserved areas by examining the potential role of pharmacies and proposing actionable strategies for improvement. The health system faces increasing criticism for failure to provide adequate access to MOUDs. Pharmacies are being promoted as an asset to increase MOUD access in rural and underserved areas.

Method: An engineering systems analysis approach was employed to investigate ways to enhance pharmacy roles in delivering MOUDs in underserved regions. Interviews were conducted with community pharmacists, pharmacy associations, and addiction treatment experts. Innovation development techniques with experts from inside and outside the field were used to create recommendations.

Results: The findings underscore the importance of embracing technological advancements to overcome resource limitations and expand MOUD access in underserved areas. When our project began, we believed pharmacy roles related to MOUD distribution could expand through traditional means. We now feel that expansion is practical only through adoption of recent developments in information and communication technology. Our recommendations offer actionable strategies to expand MOUD availability in underserved areas. Technological changes can address stigma and mindsets, workflow simplification, family engagement, integration with other parts of the health system, reimbursement practice, and regulation.

Conclusions: Implementing pertinent technological innovations could augment MOUD availability within the pharmacy sector, thus addressing the pressing need for improved access to treatment in underserved communities. These technological changes would expand MOUD access within a field constrained by limited and diminishing resources.

Related protocols: CTN-0124

This is the primary outcomes article for Aim 1 of CTN-0123.

The ongoing opioid misuse epidemic has had a marked impact on American Indian/Alaska Native (AI/AN) communities. Culture- and gender-specific barriers to medically assisted recovery from opioid use disorder (OUD) have been identified, exacerbating its impact for AI/AN women. Wiidookaage’win is a community-based participatory research study that aims to develop a culturally tailored, moderated, private Facebook group intervention to support Minnesotan AI/AN women in medically assisted recovery from OUD. The current study, NIDA Clinical Trials Network study CTN-0123, assessed the preliminary feasibility and acceptability of the intervention in a beta-test to inform refinements before conducting a pilot randomized controlled trial (RCT).

The intervention was beta-tested for 30 days. Moderators were trained prior to delivering the intervention. Study assessments were conducted at baseline and post-intervention. The post-intervention assessments included substance use (self-report and urine drug screen), treatment acceptability, mental health, and spirituality outcomes. We examined intervention engagement patterns using Facebook metrics and qualitatively explored common topics that emerged in participant posts and comments.

Ten AI/AN women taking medication for OUD (MOUD) were recruited (age range 25–62 years). Participants had been in opioid recovery a mean of 15.2 months (SD = 16.1; range = 3–60). The study participation rate (accrued/eligible) was 91%. Nine participants completed the post-intervention survey assessment and eight completed a UDS. Acceptability was high based on the mean treatment satisfaction score (M = 4.8, SD = 0.2 out of a possible 5.0), Facebook group engagement, and positive qualitative feedback. All participants retained at post-intervention continued their MOUD treatment, and none had returned to opioid use.

Conclusions: The beta-test indicated that the Facebook platform and study procedures generally worked as intended and that the intervention was largely acceptable to study participants. The results of this study phase provided valuable insights to inform refinements prior to conducting a pilot RCT to further assess the feasibility, acceptability, and potential efficacy of the intervention.

Related protocols: CTN-0123