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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: Culturally Centered MOUD Implementation Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aimee Campbell, PhD; Phone Number: 6467746138; Email: anc2002@cumc.columbia.edu
• Study Contact Backup: Name: Margaret Paschen-Wolff, PhD; Email: Margaret.Paschen-Wolff@nyspi.columbia.edu

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
      • Southcentral Foundation
      • Contact: Kelley Jansen
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Native American Community Clinic
      • Contact: Antony Stately, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Willing and able to provide informed consent
• English comprehension and proficiency
• Receiving services at a participating study site
• Meet criteria for a current opioid use disorder
• Self-identify as American Indian or Alaska Native
• Willing to have program data linked to assessment data
• 18 years or older

Exclusion Criteria:

• participation in research assessments contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Culturally Centered MOUD Implementation; Culturally centered program-level implementation intervention to increase the use of medications for opioid use disorder in healthcare and treatment settings serving AI/AN communities	Behavioral: Culturally Centered MOUD Implementation Intervention; Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
# consumers with OUD initiated onto MOUD	number of consumers with OUD initiated onto MOUD in the 6 months after intervention delivery compared to pre-intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
# consumers with OUD offered MOUD	number of consumers with OUD offered MOUD in the 6 months after intervention delivery compared to pre-intervention	6 months
# consumers screened for OUD of the overall # of new consumers	number of consumers screened for OUD of the overall number of new consumers in the 6 months after intervention delivery compared to pre-intervention	6 months
# consumers with OUD retained in care for at least three months	number of consumers with OUD retained in care for at least three months in the 6 months after intervention delivery compared to pre-intervention	6 months

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: University of New Mexico

Publications and helpful links

General Publications

• Hirchak KA, Nadeau M, Vasquez A, Hernandez-Vallant A, Smith K, Pham C, Oliver KA, Baukol P, Lizzy K, Shaffer R, Herron J, Campbell ANC, Venner KL; CTN-0096 Collaborative Board. Centering culture in the treatment of opioid use disorder with American Indian and Alaska Native Communities: Contributions from a National Collaborative Board. Am J Community Psychol. 2023 Mar;71(1-2):174-183. doi: 10.1002/ajcp.12620. Epub 2022 Aug 23.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Implementation; Alaska Native; American Indian; Medications for Opioid-use Disorder; Cultural centering
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: #8026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from this study is owned by participating Tribal clinical sites; any use of IPD requires Tribal (or equivalent organizational) approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No