What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder (OUD) include Medication-Assisted Treatment (MAT) with medications such as methadone, buprenorphine, and naltrexone, combined with counseling and behavioral therapies. Methadone can cause side effects like constipation, sweating, and potential for respiratory depression. Buprenorphine may lead to headaches, nausea, and insomnia. Naltrexone can cause gastrointestinal issues, dizziness, and liver enzyme abnormalities. Counseling and behavioral therapies generally have minimal physical side effects but may cause emotional discomfort as patients confront their substance use issues.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. These medications are often used in combination with behavioral therapies to improve treatment outcomes. Methadone and buprenorphine are opioid agonists that help reduce withdrawal symptoms and cravings, while naltrexone is an opioid antagonist that blocks the effects of opioids. The CHaRRM-CN trial's focus on cultural connectedness and harm reduction aligns with the broader trend of integrating comprehensive, patient-centered approaches in OUD treatment.

What other types of research exist?

Promising alternatives to CHaRRM-CN for OUD patients include: 1) Web-based videoconferencing platforms like eGetgoing, which provide remote counseling services; 2) Telemedicine programs that offer comprehensive care management; and 3) Integrative therapies such as music therapy, which have shown potential in enhancing treatment engagement and efficacy.

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CHaRRM Counseling for Opioid Use Disorder (CHaRRM-CN Trial)

N/A

Recruiting

Led By Ashley Lincoln, MSW

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, month 3, month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a culturally adapted counseling program called CHaRRM-CN for American Indian individuals with opioid addiction. The program aims to help them stay in treatment longer, reduce substance-related harm, and strengthen their connection to Native culture.

Who is the study for?

This trial is for adults over 18 who are new to the Cherokee Nation Health Services Medication-assisted Treatment (MAT) Program or returning after a six-month break. They must be able to understand and agree to the study's terms. People can't join if they're unable to consent or pose a risk to others' safety.

What is being tested?

The trial tests CHaRRM-CN, a program aiming to improve patient retention in MAT, reduce opioid-related harm, and boost cultural ties within the Cherokee Nation. Participants will either receive this new counseling approach or standard treatment for comparison.

What are the potential side effects?

Since this trial focuses on counseling methods rather than medication, traditional side effects like those seen with drugs aren't expected. However, participants may experience emotional discomfort discussing substance use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, month 3, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1, month 3, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, month 3, month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MAT retention

Secondary study objectives

ED visits

Illicit Opioid Use

Native enculturation

+2 more

Other study objectives

Health-related quality of life (HR-QoL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CHaRRM-CNExperimental Treatment1 Intervention

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.

Group II: Treatment as Usual (TAU)Active Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Opioid Use Disorder (OUD) include Medication-Assisted Treatment (MAT) and psychosocial interventions. MAT uses medications like methadone, buprenorphine, or naltrexone to normalize brain chemistry, block euphoric effects, and relieve cravings. Psychosocial interventions, such as Cognitive Behavioral Therapy (CBT), Contingency Management, and Motivational Interviewing, address the psychological and social aspects of addiction. The CHaRRM-CN trial emphasizes harm reduction and cultural connectedness, enhancing treatment relevance and effectiveness by aligning it with patients' cultural values. This holistic approach is crucial for improving treatment retention and reducing relapse risk.

Mindfulness-Based Intervention Effects on Substance Use and Relapse Among Women in Residential Treatment: A Randomized Controlled Trial With 8.5-Month Follow-Up Period From the Moment-by-Moment in Women's Recovery Project.Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial.A Process Evaluation of a Substance Use Brief Intervention for Adolescents in a Psychiatric Inpatient Program.