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Background: Rural communities face disproportionate rates of opioid use disorder (OUD) and overdose mortality but continue to be underrepresented in clinical research and underserved in access to medications for opioid use disorder (MOUD). Structural barriers including shortages of qualified providers, transportation challenges, and stigma limit uptake of evidence-based treatment. To address these gaps, the National Drug Abuse Treatment Clinical Trials Network (CTN) launched two pragmatic trials focused exclusively on rural populations: CTN-0102, a telemedicine (TM) feasibility study connecting rural primary care patients to external MOUD providers, and CTN-0102XR (RXR), a pilot randomized trial evaluating extended-release buprenorphine (Brixadi®) compared to sublingual buprenorphine-naloxone.

Objective: The article aims to describe the implementation of these two rural pragmatic trials, identify challenges encountered in study implementation, and present lessons learned. We applied frameworks from implementation science, including the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC), to demonstrate how pragmatic trial implementation mirrors implementation of evidence-based programs and practices, and can benefit from established implementation frameworks and strategies.

Results: Across 13 rural clinics in 10 states, both trials demonstrated the feasibility of integrating MOUD into primary care settings through pragmatic study designs closely aligned with routine clinical workflows. Principal challenges included limited clinic research capacity, staff stigma toward OUD treatment, communication barriers between local clinics and external TM vendors, and variable digital access. Solutions included engaging local champions, co-developing workflows tailored to each clinic’s operations, simplifying technology requirements, and emphasizing bi-directional communication among clinic, research, and vendor teams. Continuous technical assistance and protocol flexibility and adaptation were crucial for sustaining engagement and aligning study procedures with clinical realities. Findings demonstrated that rural clinics can feasibly implement TM-based MOUD coordination and extended-release buprenorphine with adequate support and contextual adaptation.

Conclusions: Lessons from CTN-0102 and CTN-0102XR underscore that pragmatic trials in rural settings benefit from early contextual assessment, engagement of community stakeholders, adaptable protocols, and strong implementation support. Applying implementation science frameworks facilitates solutions to real-world barriers and enhances study sustainability. Future CTN efforts should continue to prioritize rural site inclusion, capacity building, and equitable access to evidence-based OUD treatment.

Related protocols: CTN-0102, CTN-0102-XR

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

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

Rural primary care clinics can expand their medication treatment for opioid use disorder (MOUD) capacity by coordinating care with external telemedicine (TM) vendors specializing in addiction medicine. This study used mixed methods to identify factors that influence patient referrals from rural primary care clinics to TM vendors for MOUD.

Between July/August 2020 and January/February 2021, 582 patients with OUD were identified across six primary care sites; that included 68 referred to an external TM vendor to receive MOUD. Mixed effects logistic regression identified individual and site-level factors associated with being referred to the TM vendor. Clinic providers and staff participated in in-depth interviews and focus groups to discuss their considerations for referring patients to the TM vendor.

Patient referrals were positively associated with local household broadband coverage (OR=2.55, p<0.001) and negatively associated with local population density (OR=0.01, p=0.003) and the number of buprenorphine prescribers in the county (OR=0.85, p<0.001). Clinic personnel expressed appreciation for psychiatric expertise and the flexibility to access MOUD brought by the TM vendor. Perceived concerns about TM referral included a lack of trust with external providers, uncertainty about TM service quality, workflow delays, and patients’ technological and insurance challenges.

Conclusions: This study revealed several clinic-level factors that may potentially influence patient referral to TM vendor services for MOUD. To facilitate the referral process and utilization of TM vendors, efforts should be made to foster open communication and trust between clinic providers and TM vendors, streamline workflows, and improve Internet access for patients.

Related protocols: CTN-0102

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

More than half of individuals admitted for specialty substance use disorder treatment in California identify stimulants as their primary or secondary drug, yet many people who use stimulants do not seek treatment. Numerous studies have shown that contingency management (CM) is the most effective treatment for stimulant use disorder. California’s innovative Recovery Incentives Program is a groundbreaking initiative that benefits California and serves as a potential blueprint for other states. In this webinar, Drs. Freese and Urada will delve into the program’s achievements and challenges by providing an overview of the Program, and preliminary quantitative and qualitative evaluation findings. Presenters will talk about the connection to technology and the potential for telehealth implementation in the future. Time will be provided for Q&A and discussion with the audience.

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 COVID-19 pandemic strained the U.S. health care system, posing logistical challenges for community-based programs. This study surveyed 11 program directors in sexually transmitted infection (STI) clinics and syringe services programs (SSPs) that served people who use substances and are at risk for HIV in five southeastern U.S. states. The 11 sites were all participants in NIDA Clinical Trials Network (CTN) multisite protocol CTN-0082. Brief survey questions asked about programs’ use of in-person and telehealth services. Results indicated widespread reduction of in-person services and concomitant adoption of telehealth services. In STI clinics, telehealth replaced in-person visits for all but urgent treatment of active symptoms. In SSPs, in-person contact continued or increased from pre-pandemic volumes. In both programs, the most salient telehealth use barrier was limited device or internet access and limited technological ease. Services were sustained through innovative adaptations.

Conclusions: This snapshot of response to the early COVID-19 lockdown phase offers actionable guidance about service preparedness for future public health catastrophes in community-based programs serving vulnerable populations.

Opioid overdose deaths are increasing rapidly in the United States. Medications for opioid use disorder (MOUD) are effective and can be delivered in primary care, but uptake has been limited in rural communities. Referral to and coordination with an external telemedicine (TM) vendor by rural primary care clinics for MOUD (TM-MOUD) may increase MOUD access for rural patients, but we know little about perspectives on this model among key stakeholders. As part of a TM-MOUD feasibility study, this study explored TM-MOUD acceptability and feasibility among personnel and patients from seven rural primary care clinics and a TM-MOUD vendor. The study was conducted as a partnership between UCLA, the RAND Corporation, and the CTN Greater Southern California Node, Pacific Northwest Node, and Northeast Node.

Researchers conducted virtual interviews or focus groups with clinic administrators (n = 7 interviews), clinic primary care and behavioral health providers (8 groups, n = 30), other clinic staff (9 groups, n = 37), patients receiving MOUD (n = 16 interviews), TM-MOUD vendor staff (n = 4 interviews), and vendor-affiliated behavioral health and prescribing providers (n = 17 interviews). They asked about experiences with and acceptability of MOUD (primarily buprenorphine) and telemedicine (TM) and a TM-MOUD referral and coordination model. A content analysis was conducted to identify themes and participants quantitatively rated acceptability of TM-MOUD elements on a 4-item scale.

Perceived benefits of vendor-based TM-MOUD included reduced logistical barriers, more privacy and less stigma, and access to services not available locally (e.g., counseling, pain management). Barriers included lack of internet or poor connectivity in patients’ homes, limited communication and trust between TM-MOUD and clinic providers, and questions about the value to the clinic of TM-MOUD referral to external vendor. Acceptability ratings for TM-MOUD were generally high; they were lowest among frontline staff.

Conclusions: Rural primary care clinic personnel, TM-MOUD vendor personnel, and patients generally perceived referral from primary care to a TM-MOUD vendor to hold potential for increasing access to MOUD in rural communities. Increasing TM-MOUD uptake requires buy-in and understanding among staff of the TM-MOUD workflow, TM services offered, requirements for patients, advantages over clinic-based or TM services from clinic providers, and identification of appropriate patients. Poverty, along with patient hesitation to initiate treatment, creates substantial barriers to MOUD treatment generally; insufficient internet availability creates a substantial barrier to TM-MOUD.

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

The COVID-19 pandemic has changed the landscape of healthcare service delivery. This review, supported by the Greater Southern California Node and the Telemedicine Special Interest Group (SIG) of the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN), aims to describe telemedicine-delivered substance use disorder (SUD) treatments and services along the cascade of care in the U.S. after the start of the COVID-19 pandemic.

A literature review was conducted on PubMed, Embase, Web of Science, and Cochrane Library (Wiley). English-language articles that describe any healthcare services for patients with SUDs using telemedicine in the U.S. since the onset of the COVID-19 pandemic were identified (N = 33). We narratively summarized telemedicine-based service provision along the cascade of SUD care, such as screening/assessment, prescription, monitoring, recovery support, and other services.

Soon after the onset of COVID-19 and mandated restrictions, cadres of healthcare providers from different specialties mobilized to ramp up video- and audio-based services to remotely treat patients with SUDs. Medication prescription (48.5%) and individual counseling (39.4%) were the most frequently reported services delivered via telemedicine. Other steps of SUD care delivered by telemedicine characterized in our review included SUD screening and assessment (30.3%), induction (21.2%), medication management (27.3%), monitoring (27.3%), recovery support (15.2%), and referral (24.2%). Feasibility issues and challenges to implementing telemedicine included patients’ lack of access to technology and health insurance coverage, providers’ capacity limits and concerns, and clinics’ financial and office-space constraints.

Conclusions: The COVID-19 pandemic has offered a window of opportunity to advance telemedicine expertise by formalizing clinical guidance and routinizing provider in-service training in virtual SUD treatment. Findings suggest enhanced efforts to reduce disparities in telemedicine-based services.

The use of telemedicine (TM) has accelerated in recent years, yet research on the implementation and effectiveness of TM-delivered medication treatment for opioid use disorder (MOUD) has been limited. This study investigated the feasibility of implementing a care coordination model involving MOUD delivered via an external TM provider for the purpose of expanding access to MOUD for patients in rural settings.

This study, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0102, tested a care coordination model in 6 rural primary care sites by establishing referral and coordination between the clinic and a TM company for MOUD. The intervention spanned approximately 6 months from July/August 2020 to January 2021, coinciding with the peak of the COVID-19 pandemic. Each clinic tracked patients with OUD in a registry during the intervention period. A pre-/post-intervention design (N = 6) was used to assess the clinic-level outcome as patient-days on MOUD based on patient electronic health records.

All clinics implemented critical components of the intervention, with an overall TM referral rate of 11.7% among patients in the registry. Five of the 6 sites showed an increase in patient-days on MOUD during the intervention period compared to the 6-month period before the intervention (mean increase per 1,000 patients: 132 days, P = .08, Cohen’s d = 0.55). The largest increases occurred in clinics that lacked MOUD capacity or had a greater number of patients initiating MOUD during the intervention period.

Conclusions: To expand access to MOUD in rural settings, the care coordination model is most effective when implemented in clinics that have negligible or limited MOUD capacity.

Related protocols: CTN-0102

This CTN platform study aimed to examine characteristics associated with disparities in digital access (i.e., access to high speed Internet via a computer or smartphone) in American rural and urban households given that digital access has a direct impact on access to telemedicine-based services.

Using the 2019 American Community Survey, researchers from the Greater Southern California Node analyzed the proportions of geographic area, race/ethnicity, and socioeconomic status according to device and high-speed Internet access. Maximum likelihood logit estimators estimated how these factors influenced device and high-speed Internet access. Of 105,312,959 households, 32.29% were without a desktop or laptop computer with high-speed Internet (WDW), 21.51% were without a smartphone with a data plan for wireless Internet (WSW), and 14.02% were without any digital access (WDA). Nonmetropolitan households were significantly more likely to be WDA than metropolitan households. Relative to non-Hispanic Whites, non-Hispanic Blacks, American Indian or Alaska Natives, or Hispanics were significantly more likely to be WDA. When compared to households with private health insurance coverage, households WDA were significantly more likely to have no insurance or public insurance coverage. Households with any digital access reported higher income and more family members living at home. Using the same predictors, similar findings were reported for households WDW or WSW.

Conclusions: Significant disparities in digital access exist among nonmetropolitan households, racial/ethnic minority households, and lower-income households. The lack of digital access has implications for the accessibility of health care services via telemedicine and thus could exacerbate health disparities.

Watch recording on YouTube.

Presented by Erin Bonar, PhD

Dr. Bonar presents results from pilot work on behavioral interventions delivered via telemedicine and a patient portal-like system the are now being testing in a large RCT as part of the NIH Heal Prevention Initiative. The interventions are rooted in Motivational Interviewing, include an emphasis on cognitive-behavioral skills, and are highly tailored for adolescents and young adults. These promising interventions build on prior efficacious behavioral interventions that showed reductions in primary substance use outcomes and secondary effects on prescription drug misuse.