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Completed

NCT Number: NCT04958798

Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southcentral Foundation, Anchorage, Alaska, United States

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About this study

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation) but this will be exploratory. As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving services at a participating study site
  • Meet criteria for a current opioid use disorder
  • Identify as American Indian or Alaska Native
  • 18 years or older

Exclusion criteria

  • Not Applicable

Treatment and study plan

Culturally Centered MOUD Implementation Intervention

Behavioral

Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs

Primary outcomes

  1. Number of Consumers With OUD Initiated Onto MOUD

    Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)

    The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.

Secondary outcomes

  1. Number of Consumers With OUD Retained in Care

    Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)

    Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods.

  2. Number of Consumers Screened for OUD

    Time frame: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)

    Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • University of New Mexico

Registry information

Official study title

Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska

Acronym: CTN-0096

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2021
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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