Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities — CTN-0096  

Opioid-use Disorder Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). 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. ;

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

• NCT number: NCT04958798
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Contact: Aimee Campbell, PhD
• Phone: 6467746138
• Email: anc2002@cumc.columbia.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Completion date: May 31, 2024