CHaRRM Counseling for Opioid Use Disorder

(CHaRRM-CN Trial)

Recruiting at 1 trial location

Overseen By Ashley Lincoln, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Must be taking: MAT

Disqualifiers: Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

136 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Ashley Lincoln, MSW

Principal Investigator

Cherokee Nation Health Services

Lonnie A Nelson, PhD

Principal Investigator

Washington State University

Susan E Collins, PhD

Principal Investigator

University of Washington

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.

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

Treatment Details

Interventions

• CHaRRM-CN
• Treatment as usual (TAU)

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Cherokee Nation Health Services

Collaborator

Trials

2

Recruited

340+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Buprenorphine HCl buccal film (BBUP) significantly reduced pain in opioid-naive patients with chronic low back pain, showing a greater reduction in pain scores compared to placebo after 12 weeks of treatment.

BBUP was well tolerated, with common side effects including nausea and constipation, and a higher percentage of patients experienced at least a 30% reduction in pain compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. Rauck, RL., Potts, J., Xiang, Q., et al.[2022]

A retrospective analysis of 6566 patients found that the buprenorphine transdermal system (BTDS) has a similar safety profile in older adults (≥ 65 years) compared to younger adults (< 65 years), with both groups experiencing a comparable incidence of adverse events (AEs).

While BTDS is generally effective for chronic pain management in older adults, it is associated with a higher risk of specific AEs like constipation and urinary tract infections, and caution is advised due to potential risks such as falls and injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of buprenorphine transdermal system in the management of pain in older adults. Pergolizzi, JV., Raffa, RB., Marcum, Z., et al.[2022]

Initiating buprenorphine treatment for opioid use disorder (OUD) in hospitals or emergency departments significantly increases the likelihood of patients continuing medication-assisted treatment, with follow-up rates between 47% to 74%, compared to traditional referral methods.

Starting buprenorphine in the inpatient setting not only improves patient transitions to outpatient care but also reduces healthcare costs, highlighting the importance of addressing regulatory and logistical challenges to implement these programs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initiation of buprenorphine for opioid use disorder in the hospital setting: Practice models, challenges, and legal considerations. Mospan, GA., Chaplin, M.[2022]

In a study of 305 patients with HIV/AIDS undergoing buprenorphine maintenance treatment (BMT), 13% reported recent incarceration, but this did not significantly affect their treatment retention or self-reported opioid use after 6 and 12 months.

Patients with recent incarceration were more likely to face challenges such as homelessness and unemployment, yet their treatment outcomes were comparable to those without recent incarceration, suggesting that BMT can be effective regardless of recent criminal justice involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent incarceration and buprenorphine maintenance treatment outcomes among human immunodeficiency virus-positive patients. Riggins, DP., Cunningham, CO., Ning, Y., et al.[2019]

Buprenorphine is an effective treatment for both opioid use disorder (OUD) and cancer-related pain, offering a lower side effect profile and the ability to address both issues simultaneously, making it a valuable option in outpatient palliative care.

Despite its benefits, barriers such as clinician experience, insurance authorization, and stigma hinder the initiation of buprenorphine therapy, highlighting the need for strategies to overcome these challenges in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Barriers to Buprenorphine Therapy for Cancer-Related Pain and Concurrent Opioid Use Disorder: A Case Report. Seecof, OM., Kuwata, C., DiBiase, J., et al.[2023]

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]

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

Safety of buprenorphine transdermal system in the management of pain in older adults. [2022]

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]

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

Recent incarceration and buprenorphine maintenance treatment outcomes among human immunodeficiency virus-positive patients. [2019]

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]