Indigenous Recovery Planning for American Indians

Alcohol Use Disorder Clinical Trial

Official title:

Randomized Controlled Trial of Indigenous Recovery Planning for American Indians

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05612061
• Other study ID #: 5R01DA053791-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: February 2026

Study information

• Verified date: October 2023
• Source: Montana State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research project uses a Community-Based Participatory Research (CBPR) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the Fort Peck Indian Reservation in northeastern Montana and research partners from Montana State University. The Indigenous Recovery Planning intervention employs trained Fort Peck community members to deliver manualized intervention content to American Indian adults with substance use disorder (SUD). By increasing access to culturally responsive evidence-based treatment, this research aims to decrease SUD-related health disparities and improve public health outcomes for underserved Native communities locally and nationally.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Indian, 18 years of age or older, living on the Fort Peck reservation, meeting diagnostic criteria for Substance Use Disorder, wanting treatment/help with recovery.

Exclusion Criteria:

• Not meeting inclusion criteria.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Indigenous Recovery Planning
The Indigenous Recovery Planning (IRP) intervention consists of a 6-week group-based intervention. Each of the 6 weekly sessions is delivered by a community member facilitator. Facilitators lead the group through a series of culturally adapted relapse prevention exercises designed to change their substance use. Focus areas for the 6 sessions are: 1) introduction and goal setting; 2) relapse and recovery; 3) craving, mindfulness, and self-compassion; 4) coping with trauma and stress; 5) enlisting social support for recovery; 6) envisioning and planning for the future.

Locations

Country	Name	City	State
United States	Fort Peck Community College	Poplar	Montana

Sponsors (1)

Lead Sponsor	Collaborator
Montana State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life score	Measured by the World Health Organization Brief Quality of Life Scale	Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)
Primary	Percent days absent	Percent days absent will be measured using the Timeline Followback (TLFB), a widely used calendar-based recall instrument shown to yield valid and reliable estimates of substance use behavior. Additional analyses will be conducted with other variables derived from TLFB data, including number of drinks per drinking day, percent heavy drinking days, and percent drug use days.	At Time 1, we will assess alcohol and drug use in the 90 days prior to assessment, and each subsequent assessment will measure use in the time since the previous one (approximately 6 weeks).
Secondary	Number of substance-related consequences experienced within the past 6 weeks	Measured by the Drinker Inventory of Consequences, modified for alcohol and drug use	Measured at baseline and each 6 week follow-up assessment time point (time 1-time 5)