CHaRRM Counseling for Opioid Use Disorder

(CHaRRM-CN Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ashley Lincoln, MSW

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Washington State University

Must be taking: MAT

Disqualifiers: Inability to consent, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves patients in a medication-assisted treatment (MAT) program, it is likely that you will continue with your current MAT medications.

How is the drug CHaRRM-CN different from other treatments for opioid use disorder?

CHaRRM-CN involves the use of buprenorphine, which is unique because it can be administered in various forms such as buccal film and transdermal systems, offering flexibility in treatment. It is effective for both opioid use disorder and chronic pain, making it versatile compared to other treatments that may not address both conditions simultaneously.

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Eligibility Criteria

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.

Inclusion Criteria

I recently joined the CNHS MAT Program or it's been 6 months since my last treatment there.

Must be willing to provide written informed consent to enroll in this study

I am 18 years old or older.

Exclusion Criteria

Refusal or inability to consent and constituting a risk to the safety and security of other patients or staff

I am able and willing to give consent for research participation.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants attend a baseline assessment and are randomized to either the CHaRRM-CN or treatment as usual group

1 week

1 visit (in-person)

Treatment

Participants receive either CHaRRM-CN or treatment as usual for 6 months

6 months

3 visits (in-person) at month 1, month 3, and month 6

Follow-up

Participants are monitored for retention, substance-use outcomes, and Native enculturation after treatment

6 months

Participant Groups

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.

Group I: CHaRRM-CN Experimental Treatment 1 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 Control 1 Intervention

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

CHaRRM-CN is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Buprenorphine for:

• Opioid use disorder
• Severe pain

🇪🇺 Approved in European Union as Buprenorphine for:

• Opioid dependence
• Severe pain

🇨🇦 Approved in Canada as Buprenorphine for:

• Opioid use disorder
• Severe pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cherokee Nation Health Services Tahlequah, OK

University of Washington School of Medicine Seattle, WA

Who Is Running the Clinical Trial?

Washington State University Lead Sponsor

University of Washington Collaborator

Cherokee Nation Health Services Collaborator

National Institute on Drug Abuse (NIDA) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. [2022] Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA(®)) delivery technology. Buccal buprenorphine (BBUP; Belbuca(TM), Endo Pharmaceuticals) was evaluated for the management of moderate to severe chronic low back pain (CLBP) requiring around-the-clock analgesia in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-naive patients.

2. England pubmed.ncbi.nlm.nih.gov

Safety of buprenorphine transdermal system in the management of pain in older adults. [2022] To evaluate whether buprenorphine transdermal system (BTDS; Butrans®) is an option for the treatment of chronic pain in older adults.

3. England pubmed.ncbi.nlm.nih.gov

Initiation of buprenorphine for opioid use disorder in the hospital setting: Practice models, challenges, and legal considerations. [2022] To provide health-system pharmacists with published examples of strategies utilized to offer buprenorphine to inpatients with opioid use disorder (OUD) along with information on challenges and legal considerations.

4. United States pubmed.ncbi.nlm.nih.gov

Recent incarceration and buprenorphine maintenance treatment outcomes among human immunodeficiency virus-positive patients. [2019] Opioid use disorder is a common cause of morbidity and mortality among people living with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Buprenorphine maintenance treatment (BMT) is an effective means of therapy, but patients with recent criminal justice involvement may need more support during BMT than other patients. The authors hypothesized that recently incarcerated BMT patients who initiated treatment in primary care would have poorer treatment outcomes than those who were not recently incarcerated.

5. United States pubmed.ncbi.nlm.nih.gov

Exploring the Barriers to Buprenorphine Therapy for Cancer-Related Pain and Concurrent Opioid Use Disorder: A Case Report. [2023] Although buprenorphine is widely accepted as a treatment option for opioid use disorder (OUD), it is underutilized as a treatment for cancer-related pain. Owing to its decreased side effect profile, various formulations (depending on FDA indication of pain versus OUD), and ability to simultaneously address OUD and pain, buprenorphine is gaining popularity in the outpatient palliative medicine setting. Despite these compelling benefits, there are significant barriers to initiating therapy. These barriers include clinician experience, insurance authorization, pharmacy supply, and stigma. We present a complicated case to describe the practical clinical experience of an attempt at low-dose initiation of buprenorphine to treat cancer-related pain in a patient with concurrent OUD and to discuss ways to start overcoming the encountered barriers.