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

NCT04958798 | Completed DMC

• 1 other identifier: #8026
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Opioid-use Disorder

Keywords

American Indian; Alaska Native; Medications for Opioid-use Disorder; Implementation; Cultural centering

Outcome Measures

Primary Outcomes (1)

• # 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 Outcomes (3)

• # consumers with OUD offered MOUD

  6 months

• # consumers screened for OUD of the overall # of new consumers

  6 months

• # consumers with OUD retained in care for at least three months

  6 months

Study Arms (1)

Culturally Centered MOUD Implementation

EXPERIMENTAL

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

Interventions

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

Culturally Centered MOUD Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• participation in research assessments contraindicated

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• University of New Mexico: collaborator

Study Sites (3)

Southcentral Foundation

Anchorage, Alaska, 99508, United States

Location

Native American Community Clinic

Minneapolis, Minnesota, 55404, United States

Location

Missouri Breaks

Eagle Butte, South Dakota, 57625, United States

Location

Related Publications (2)

• 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.

  PMID: 35997562 BACKGROUND

• Paschen-Wolff MM, Campbell ANC, Vasquez A, Kessler J, Jansen K, Arnatt CP, Rosa C, Hebden HM, Radin S, Stately A, Shaw J, Kennedy F, Matthews AG, Venner KL. Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations. Contemp Clin Trials. 2025 Aug;155:107992. doi: 10.1016/j.cct.2025.107992. Epub 2025 Jun 20.

  PMID: 40544955 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: December 20, 2021
• Primary Completion: December 13, 2024
• Study Completion: January 16, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)