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

Opioid-use Disorder Clinical Trial

— CTN-0096  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958798
• Other study ID #: #8026
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: New York State Psychiatric Institute
• Contact: Aimee Campbell, PhD
• Phone: 6467746138
• Email: anc2002[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Southcentral Foundation	Anchorage	Alaska
United States	Native American Community Clinic	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	# 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	# 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
Secondary	# 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
Secondary	# 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