Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation

NCT05733442 | Active Not Recruiting DMC

• 2 other identifiers: CNIRB 337R33DA049376
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized clinical trial is to test the efficacy of a program meant to enhance Counseling for Harm Reduction and Retention in MAT in Cherokee Nation (CHaRRM-CN). The main questions it aims to answer are whether CHaRRM-CN: improves retention of patients in MAT, decreases substance-related harm and illicit opioid use, and increases cultural connectedness. After providing written, informed consent, participants will attend a baseline assessement and will then be randomized to either the CHaRRM-CN or treatment as usual group. For 6 months after randomization, participants will be exposed to CHaRRM-CN or treatment as usual. During that time, participants will also attend the 1-month, 3-month and 6-month follow-ups to track their progress through the programs. After the 6 months of either treatment condition, investigators will compare the groups to see if they differ on retention, substance-use outcomes and Native enculturation.

Conditions

Opioid Use Disorder

Keywords

opioid use disorder; harm reduction; medication assisted treatment; American Indian

Outcome Measures

Primary Outcomes (1)

• MAT retention

  MAT program retention is defined by an active prescription for buprenorphine+naloxone with no gaps ≥ 30 days at month 6. This measure will dichotomously indicate whether participants have been retained in the MAT program (1) or not (0) at month 6.

  Month 6

Secondary Outcomes (5)

• Substance-related harm

  Baseline, month 1, month 3, month 6

• Native enculturation

  Baseline, month 1, month 3, month 6

• Native self-reliance

  Baseline, month 1, month 3, month 6

• Illicit Opioid Use

  Baseline, month 1, month 3, month 6

• ED visits

  Baseline, month 6

Other Outcomes (1)

• Health-related quality of life (HR-QoL)

  Baseline, month 1, month 3, month 6

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

The TAU condition will entail the current CNHS MAT program for OUD.

Other: Treatment as usual (TAU)

CHaRRM-CN

EXPERIMENTAL

The CHaRRM-CN condition comprises changes and additions to TAU codesigned with a community advisory board and taking into account suggestions from MAT patients and community members impacted by OUD with the goal of improving MAT retention in culturally aligned and community-driven ways.

Other: CHaRRM-CN

Interventions

Treatment as usual (TAU) OTHER

TAU entails medication to support patients' recovery (i.e., the partial opioid agonist, buprenorophine + naloxone/ Suboxone gel films), in-person case management and behavioral health intervention (i.e., in-person group and individual counseling), and referrals to other health care and behavioral health services.

Treatment as Usual (TAU)

CHaRRM-CN OTHER

The CHaRRM-CN intervention includes changes and additions to TAU to make MAT more culturally aligned (i.e., offering regular community-based, cultural programming; offering culturally aligned healing groups in the MAT program, such as Talking Circles and beading group) as well as lower barrier and incentivized (i.e., offering medication and behavioral health appointments via in-person, videoconference or telephone; offering harm-reduction groups in addition to abstinence-based groups; providing mailed and in-person pick-up options for buprenorphine prescriptions; conducting weekly chart reviews to ensure prescriptions and basic needs are continuously met; bimonthly, automated text outreach; contingency management supporting attendance at in-person or telehealth appointments).

CHaRRM-CN

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Must be newly registered (within 4 weeks) in the CNHS MAT Program. (Prior patients can participate as long as their most recent treatment course was at least 6 months prior).
• Must be willing to provide written informed consent to enroll in this study

You may not qualify if:

• Refusal or inability to consent to participation in research. (The latter is assessed using the UCSD Brief Assessment of Capacity to Consent.)
• Refusal or inability to consent and constituting a risk to the safety and security of other patients or staff

Sponsors & Collaborators

• Washington State University: lead
• University of Washington: collaborator
• Cherokee Nation Health Services: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Cherokee Nation Health Services

Tahlequah, Oklahoma, 74464, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Harm Reduction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Lonnie A Nelson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

• Susan E Collins, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Ashley Lincoln, MSW

  Cherokee Nation Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: January 17, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)