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

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

Interventions

OTHER

Treatment as usual (TAU)

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.

OTHER

CHaRRM-CN

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).

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• Cherokee Nation Health Services

  collaborator UNKNOWN

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Washington State University

  lead OTHER

Principal Investigators

• Lonnie A Nelson, PhD · Washington State University

• Susan E Collins, PhD · University of Washington

• Ashley Lincoln, MSW · Cherokee Nation Health Services

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-17

Primary Completion

2026-05-15

Completion

2026-07-31

Countries

• United States

Study Locations