NCT05733442 Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
| NCT ID | NCT05733442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington State University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2023-01-17 |
| Primary Completion | 2025-06-30 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age 2. 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). 3. Must be willing to provide written informed consent to enroll in this study Exclusion Criteria: 1. Refusal or inability to consent to participation in research. (The latter is assessed using the UCSD Brief Assessment of Capacity to Consent.) 2. Refusal or inability to consent and constituting a risk to the safety and security of other patients or staff