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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

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

Background: American Indian and Alaska Native (AI/AN) communities experienced a disproportionate increase in opioid-related fatal and non-fatal poisonings during the COVID-19 pandemic. Access to treatment, such as medications for opioid use disorder (MOUD), became even more critical, although research among this population is limited. We completed qualitative interviews with substance use disorder (SUD) treatment providers (i.e., MOUD prescribers, non-prescribing clinicians, non-clinical support staff) to assess the impact of COVID-19 on MOUD care among AI/AN adults.

Methods: This research was completed in connection with two CTN studies: CTN-0096 and CTN-0118. Sixty-minute semi-structured interviews were completed with providers working in SUD treatment (N = 25). Eligible providers represented 6 programs serving rural Tribal and urban areas primarily in the Pacific Northwest United States. Transcripts were independently reviewed and analyzed for themes based upon the research aims.

Results: Nineteen female and six male providers completed interviews. Four themes were identified: (1) Beneficial policy changes for MOUD delivery; (2) Telehealth as the biggest policy shift; (3) Addressing complexity, and (4) Cultural services. Findings indicated providers viewed the introduction of telehealth, implementation of mobile services, and expanded take home dosing as positive and leading to increased treatment access. However, barriers related to the internet, transportation, and reimbursement of telehealth remain.

Conclusions: Providers highlighted the utility in the expansion and sustainment of telehealth. Flexible policies for MOUD were particularly beneficial during the height of COVID-19 to maintain and increase access to treatment. Providing a menu of treatment options, emphasizing cultural engagement and social support were deemed necessary to enhance AI/AN community driven solutions in curbing the opioid poisoning public health crisis.

Related protocols: CTN-0096, CTN-0118

Background: Incorporating American Indian and Alaska Native (AI/AN) traditional practices and knowledge into healthcare can support AI/AN health. Drug overdose deaths disproportionately impact AI/AN communities due to colonization, genocide, historical trauma, discriminatory policies, and under-resourced healthcare. Medications for opioid use disorder (MOUD; e.g., buprenorphine, methadone, naltrexone) are considered the most effective treatment for reducing mortality. Integrating AI/AN cultural practices with MOUD may increase acceptability and uptake of MOUD within AI/AN communities.

Methods: National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Protocol #0096 (Tribal MOUD) is a two-phase community-based participatory research (CBPR) trial to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities (N = 4 sites). A Collaborative Board (CB) guided intervention development (Phase I completed). A stepped wedge design (two sites/step) allows intervention implementation at all sites and improvements across sites (Phase II ongoing). The primary implementation outcome is the number of consumers with OUD who initiate MOUD in the six months pre-intervention vs. implementation periods; secondary outcomes are MOUD screening and retention (de-identified electronic medical record data). Additional data include organizational predictors (staff surveys) and moderators (consumer assessments) of implementation outcomes; and MOUD intervention acceptability (staff/consumer qualitative interviews).

Conclusions: This is the first study to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities. Implementation science and CBPR are complimentary for co-developing strategies with AI/AN communities to integrate Indigenous and Western best practices, which may ultimately reduce opioid-related mortality among AI/AN peoples and enhance Indigenous community wellness.

Related protocols: CTN-0096

This presentation was delivered as part of a symposium at the 2024 CPDD conference entitled, “Two-Eyed Seeing for Opioid Use Disorder Treatment and Recovery with American Indian and Alaska Native Communities,” moderated by Aimee Campbell and Carmen Rosa. In this section of the symposium, Dr. Patten discussed the development and testing of a novel, moderated, private Facebook group intervention to support AI/AN women in opioid use disorder recovery. The intervention was developed through feedback from key partners and beta tested and refined with AI/AN women in recovery.

Related protocols: CTN-0123

COVID-19 exacerbated the opioid-related poisoning crisis among many American Indian/Alaska Native (AI/AN) communities. There is a lack of research examining the extent of the impact of the pandemic on the delivery of treatment for opioid use disorder (OUD) in this population. In collaboration with an Indigenous Collaborative Board, Tribal leadership and administration, this study, part of CTN-0118, explored AI/AN SUD-serving treatment providers’ experiences delivering treatment for OUD from 2020-2022. Eligible providers (N=25) represented 6 programs and organizations serving Tribal and urban areas primarily in the Pacific Northwest. Two members of the research team independently reviewed transcripts before reaching consensus on a finalized codebook and analysis was informed by a qualitative descriptive approach. Findings indicated providers viewed the changes to telemedicine, medication dosing, and the introduction of mobile services as a positive and increased access to care. Barriers remained, however, including when programs discontinued services and reverted to pre-pandemic policy (e.g., no longer mailing prescriptions). This study highlights the impact of the COVID-19 pandemic and what was perceived as effective in the delivery and sustainment of telemedicine, medications, as well as the continued necessity to provide a menu of treatment and social service options to meet the unique needs of AI/AN communities. Study results may inform future programmatic and organizational systems change among AI/AN communities to enhance access and SUD service engagement beyond emergency response efforts.

Related protocols: CTN-0118

Introduction: American Indian/Alaska Native (AI/AN) communities are more likely to suffer negative consequences related to substance misuse. The COVID-19 pandemic exacerbated the opioid poisoning crisis, in combination with ongoing treatment barriers resulting from settler-colonialism, systemic oppression and racial discrimination. AI/AN adults are at greatest risk of COVID-19 related serious illness and death. In collaboration with an Indigenous community advisory board and Tribal leadership, this study, supported by CTN-0118, explored AI/AN treatment provider perceptions of client-relatives’ (i.e., SUD treatment recipients) experiences during the pandemic from 2020 to 2022.

Methods: Providers who underwent screening and were eligible to participate (N = 25) represented 6 programs and organizations serving rural and urban areas in Washington, Utah, and Minnesota. Participants engaged in audio-recorded 60-90 min semi-structured individual interviews conducted virtually via Zoom. The interview guide included 15 questions covering regulatory changes, guidance for telemedicine, policy and procedures, staff communication, and client-relatives’ reactions to implemented changes, service utilization, changes in treatment modality, and perceptions of impact on their roles and practice. Interview recordings were transcribed and de-identified. Members of the research team independently reviewed transcripts before reaching consensus. Coding was completed in Dedoose, followed by analyses informed by a qualitative descriptive approach.

Results: Five main domains were identified related to client-relative experiences during the COVID-19 pandemic, as observed by providers: (1) accessibility, (2) co-occurring mental health, (3) social determinants of health, (4) substance use, coping, and harm reduction strategies, and (5) community strengths. Providers reported the distinctive experiences of AI/AN communities, highlighting the impact on client-relatives, who faced challenges such as reduced income, heightened grief and loss, and elevated rates of substance use and opioid-related poisonings. Community and culturally informed programming promoting resilience and healing are outlined.

Conclusion: Findings underscore the impact on SUD among AI/AN communities during the COVID-19 pandemic. Identifying treatment barriers and mental health impacts on client-relatives during a global pandemic can inform ongoing and future culturally responsive SUD prevention and treatment strategies. Elevating collective voice to strengthen Indigenous informed systems of care to address the gap in culturally-and community-based services, can bolster holistic approaches and long-term service needs to promote SUD prevention efforts beyond emergency response efforts.

Related protocols: CTN-0118

American Indian and Alaska Native (AI/AN) communities experienced a disproportionate increase in opioid-related poisonings during COVID-19. Availability of treatment, such as medications for opioid use disorder (MOUD) within AI/AN communities, is therefore imperative. We completed qualitative interviews with substance use disorder treatment providers providing services to AI/AN adults to assess the impact of COVID-19 related regulatory changes (e.g., medication dosing) and transitions in services (i.e., telemedicine) that aimed to enhance access to care. This project was supported by CTN-0118.

Related protocols: CTN-0118

The COVID-19 pandemic exacerbated the drug poisoning crisis in American Indian/Alaska Native communities, in combination with ongoing substance use disorder (SUD) treatment barriers resulting from settler-colonialism, systemic oppression and racial discrimination. For similar reasons, AI/AN adults also experienced increased risk of COVID-19 related serious illness and death. In collaboration with an AI/AN Collaborative Board and Tribal leadership and administration, this study, supported by CTN-0118, explored AI/AN SUD treatment providers’ perception of client-relatives’ (i.e., SUD treatment recipients) experiences (e.g. substance use) during the height of the pandemic (2020-2022).

Related protocols: CTN-0118

The purpose of this study, NIDA Clinical Trials Network protocol CTN-0123 was to develop a culturally-tailored American Indian/Alaska Native (AI/AN) women’s Facebook group supporting opioid recovery as an adjunct to medication. Participants were AI/AN women in Minnesota in opioid recovery, interested parties, and a Community Advisory Committee (CAC) of AI/AN women with lived experience, health care providers, and community members.

For the intervention, the study team developed evidence-based content focusing on stress/trauma and substance use, mindfulness, responding to triggers, and supportive community resources. Additional content centered on AI/AN culture was also selected.

Interviews were conducted by two women, then transcribed and coded using content analysis with NVivo software. Results were presented to CAC for further content refinement.

CAC members (n = 10) guided study methods, intervention development, and dissemination activities. 14 AI/AN women (mean age 36.4 years; mean 6.7 months opioid abstinence) and 12 interested parties (7 men, 5 women) were receptive to an AI/AN gender-specific Facebook group, preferring content with AI/AN people and/or text resonating with AI/AN culture (e.g., Native traditions, family, personal stories, historical trauma). Recommendations included (1) protect confidentiality, (2) retain positivity, (3) incorporate resources and exercises to build coping skills, and (4) moderators should be authentic and relatable to build trust.

Conclusions: This approach provides a model for developing culturally tailored, appealing and effective social media interventions to support AI/AN women in recovery from opioid use disorder.

Related protocols: CTN-0123

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

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

American Indian and Alaska Native (AI/AN) populations are disproportionately affected by substance use disorders (SUDs) and related health disparities in contrast to other ethnoracial groups in the United States. Over the past 20 years, substantial resources have been allocated to NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN) to disseminate and implement effective SUD treatments in communities. However, we know little about how these resources have benefitted AI/AN peoples with SUD who arguably experience the greatest burden of SUDs. This review aims to determine lessons learned about AI/AN substance use and treatment outcomes in the CTN and the role of racism and Tribal identity.

The authors conducted a scoping review informed by the Joanna Briggs framework and PRISMA Extension for Scoping Reviews checklist and explanation. The study team conducted the search strategy within the CTN Dissemination Library and nine additional databases for articles published between 2000 and 2021. The review included studies if they reported results for AI/AN participants. Two reviewers determined study eligibility.

A systematic search yielded 13 empirical articles and six conceptual articles. Themes from the 13 empirical articles included: (1) Tribal Identity: Race, Culture, and Discrimination; (2) Treatment Engagement: Access and Retention; (3) Comorbid Conditions; (4) HIV/Risky Sexual Behaviors; and (5) Dissemination. The most salient theme was Tribal Identity: Race, Culture, and Discrimination, which was present in all articles that included a primary AI/AN sample (k = 8). Themes assessed but not identified for AI/AN peoples were Harm Reduction, Measurement Equivalence, Pharmacotherapy, and Substance Use Outcomes. The conceptual contributions used AI/AN CTN studies as exemplars of community-based and Tribal participatory research (CBPR/TPR).

Conclusions: CTN studies conducted with AI/AN communities demonstrate culturally congruent methods, including CBPR/TPR strategies; consideration/assessment of cultural identity, racism, and discrimination; and CBPR/TPR informed dissemination plans. Although important efforts are underway to increase AI/AN participation in the CTN, future research would benefit from strategies to increase participation of this population. Such strategies include reporting AI/AN subgroup data; addressing issues of cultural identity and experiences of racism; and adopting an overall effort for research aimed at understanding barriers to treatment access, engagement, utilization, retention, and outcomes for both treatment and research disparities for AI/AN populations.

American Indian/Alaska Native (AI/AN) communities are disproportionally impacted by the opioid overdose epidemic. There remains a dearth of research evaluating methods for effectively implementing treatments for opioid use disorder (OUD) within these communities. We describe proceedings from a 2-day Collaborative Board (CB) meeting tasked with developing an implementation intervention for AI/AN clinical programs to improve the delivery of medications to treat OUD (MOUD). The CB was comprised of Elders, cultural leaders, providers, individuals with lived experience with OUD, and researchers from over 25 communities, organizations, and academic institutions.

Conversations were audio-recorded, transcribed, and coded by two academic researchers with interpretation oversight provided by the CB. These proceedings provided a foundation for ongoing CB work and a frame for developing the program-level implementation intervention using a strength-based and holistic model of OUD recovery and wellbeing. Topics of discussion posed to the CB included engagement and recovery strategies, integration of extended family traditions, and addressing stigma and building trust with providers and clients. Integration of traditional healing practices, ceremonies, and other cultural practices was recommended. The importance of centering AI/AN culture and involving family were highlighted as priorities for the intervention.

Related protocols: CTN-0096