Culturally tailored digital therapeutic for substance use disorders with urban Indigenous people in the United States: A randomized controlled study.

INTRODUCTION: Indigenous people experience health disparities, including higher rates of substance use disorders (SUDs). Digital therapeutics are a growing platform for treatment services and have the potential to expand access to culturally responsive interventions for Indigenous people. As one of the first randomized controlled trials for SUDs for American Indian and Alaska Native (AI/AN) adults, the aim of this study was to pilot test the efficacy of a culturally tailored intervention among urban Indigenous adults. METHODS: The study used a randomized controlled parallel design of 12 weeks of treatment-as-usual (TAU) (n = 26) versus TAU + Therapeutic Education System-Native Version (TES-NAV) (n = 27) with follow-up assessments at end of treatment and week 24 in an urban outpatient addiction treatment program for Native American adults. TAU consisted of individual/group counseling and cultural activities. The TES-NAV arm comprised TAU + 26 self-directed culturally tailored digital skills-based modules grounded in the community reinforcement approach with contingency management for abstinence and module completion. Primary outcome was longest consecutive weeks of abstinence from drugs and heavy drinking measured using self-report (Timeline Followback) and urine alcohol and drug toxicology screen during 12 weeks of treatment. Secondary outcomes were percent days abstinence during and posttreatment, coping strategies, social connectedness, and substance use and sexual risk behaviors. RESULTS: The study enrolled fifty-three (52.8 % male) AI/AN adults seeking treatment for a SUD. Although the study did not detect a benefit of TAU+TES-NAV over TAU on the primary outcome (Median = 2 consecutive weeks of abstinence for both arms) at end of treatment (treatment effect: Z = -0.78, p = 0.437), TAU+TES-NAV participants did demonstrate significantly greater percent days of abstinence at the week 24 follow-up (69.3 % versus 49.0 % for TAU; t = 2.08, p = 0.045) and significantly greater change in social connectedness mean score, baseline to week 12 (Z = -2.66, p = 0.011), compared to TAU. The study detected no differences between treatment arms for coping strategies or risk behaviors. CONCLUSION: The addition of TES-NAV to TAU did not significantly improve consecutive weeks of abstinence from drugs or heavy drinking; however, several secondary findings suggest promise for a culturally tailored digital therapeutic SUD intervention among urban Indigenous people. CLINICAL TRIALS: GOV REGISTRATION: #NCT03363256.

Interpretation and integration of the federal substance use privacy protection rule in integrated health systems: A qualitative analysis.

BACKGROUND: Federal regulations (42 CFR Part 2) provide special privacy protections for persons seeking treatment for substance use disorders. Primary care providers, hospitals, and health care organizations have struggled to balance best practices for medical care with adherence to 42 CFR Part 2, but little formal research has examined this issue. The aim of this study was to explore institutional variability in the interpretation and implementation of 42 CFR Part 2 regulations related to health systems data privacy practices, policies, and information technology architecture. METHODS: This was a cross-sectional qualitative study using purposive sampling to conduct interviews with privacy/legal officers (n = 17) and information technology specialists (n = 10) from 15 integrated healthcare organizations affiliated with three research nodes of the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN). Trained staff completed a short survey and digitally recorded semi-structured qualitative interview with each participant. Interviews were transcribed and coded within Atlas.ti. Framework analysis was used to identify and organize key themes across selected codes. RESULTS: Participants voiced concern over balancing patient safety with 42 CFR Part 2 privacy protections. Although similar standards of protection regarding release of information outside of the health system was described, numerous workarounds were used to manage intra-institutional communication and care coordination. To align 42 CFR Part 2 restrictions with electronic health records, health systems used sensitive note designation, "break the glass" technology, limited role-based access for providers, and ad hoc solutions (e.g., provider messaging). CONCLUSIONS: In contemporary integrated care systems, substance-related EHR records (e.g., patient visit history, medication logs) are often accessible internally without specific consent for sharing despite the intent of 42 CFR Part 2. Recent amendments to 42 CFR Part 2 have not addressed information sharing needs within integrated care settings.

Future directions for medication assisted treatment for opioid use disorder with American Indian/Alaska Natives.

The U.S. is experiencing an alarming opioid epidemic, and although American Indians and Alaska Natives (AI/ANs) are especially hard hit, there is a paucity of opioid-related treatment research with these communities. AI/ANs are second only to Whites in the U.S. for overdose mortality. Thus, the National Institute on Drug Abuse convened a meeting of key stakeholders to elicit feedback on the acceptability and uptake of medication assisted treatment (MAT) for opioid use disorders (OUDs) among AI/ANs. Five themes from this one-day meeting emerged: 1) the mismatch between Western secular and reductionistic medicine and the AI/AN holistic healing tradition; 2) the need to integrate MAT into AI/AN traditional healing; 3) the conflict between standardized MAT delivery and the traditional AI/AN desire for healing to include being medicine free; 4) systemic barriers; and 5) the need to improve research with AI/ANs using culturally relevant methods. Discussion is organized around key implementation strategies informed by these themes and necessary for the successful adoption of MAT in AI/AN communities: 1) type of medication; 2) educational interventions; 3) coordination of care; and 4) adjunctive psychosocial counseling. Using a community-based participatory research approach is consistent with a "two eyed seeing" approach that integrates Western and Indigenous worldviews. Such an approach is needed to develop impactful research in collaboration with AI/AN communities to address OUD health disparities.

American Indians with substance use disorders: treatment needs and comorbid conditions.

BACKGROUND: American Indians and Alaska Natives (AI/ANs) experience significant disparities in health status and access to care. Furthermore, only limited data are available on substance use, mental health disorders, and treatment needs for this population. Addressing such disparities and developing culturally relevant, effective interventions for AI/AN communities require participatory research. OBJECTIVES AND METHODS: The Western States Node of the National Institute on Drug Abuse Clinical Trials Network partnered with two American Indian substance abuse treatment programs: an urban health center and a reservation-based program to assess client characteristics, drug use patterns, and treatment needs. Data collected by staff members at the respective programs from urban (n = 74) and reservation (n = 121) clients were compared. Additional sub-analysis examined patients reporting regular opioid use and mood disorders. RESULTS: Findings indicate that urban clients were more likely to report employment problems, polysubstance use, and a history of abuse. Reservation-based clients reported having more severe medical problems and a greater prevalence of psychiatric problems. Clients who were regular opioid users were more likely to report having a chronic medical condition, suicidal thoughts, suicide attempts, polysubstance abuse, and IV drug use. Clients who reported a history of depression had twice as many lifetime hospitalizations and more than five times as many days with medical problems. CONCLUSIONS: Findings from this project provide information about the patterns of substance abuse and the importance of comprehensive assessments of trauma and comorbid conditions. Results point to the need for integrative coordinated care and auxiliary services for AI/AN clients seeking treatment for substance use disorders.