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

NCT04958798 | Completed Results DMC

• 1 other identifier: #8026
• Study Type: interventional
• Target: 2,059
• 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)

• Number of Consumers With OUD Initiated Onto MOUD

  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.

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

Secondary Outcomes (2)

• Number of Consumers With OUD Retained in Care

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

• Number of Consumers Screened for OUD

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

Study Arms (1)

Culturally Centering MOUD Program Implementation Intervention

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 Centering MOUD Program Implementation Intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Not Applicable

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)

• 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 BACKGROUND

• 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

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Data for a secondary outcome described in the protocol (# of participants with OUD offered a MOUD) was unable to be collected and analyzed using the EMR data and is therefore not reported. Adverse events were not collected; analytic sample was comprised of de-identified EMR data.

Results Point of Contact

• Title: Kamilla Venner, PhD
• Organization: Center on Alcohol, Substance use, & Addiction (CASAA), University of New Mexico (UNM)

kamilla@unm.edu

(505) 933-9590

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: All sites (N=4) started in standard/usual care and then were randomly assigned to receive the program level implementation intervention in sequence 1 (2 sites) or sequence 2 (2 sites).

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 11, 2026
• Results First Posted: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)