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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new program designed to improve counseling for individuals dealing with opioid use disorder. It will compare a new approach, called CHaRRM-CN, with the usual treatment, which may include medications like buprenorphine, to determine if it helps patients remain in treatment longer, reduces harm from drug use, and strengthens cultural ties. Participants will follow either the usual treatment or the new program for six months, with check-ins at 1, 3, and 6 months. This trial suits individuals who have started treatment for opioid use disorder within the last four weeks in the Cherokee Nation Health System. As an unphased trial, this study offers participants the opportunity to contribute to innovative approaches in opioid use disorder treatment.

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.

What prior data suggests that the CHaRRM-CN program is safe for participants?

Research has shown that the CHaRRM-CN program is a counseling method designed to improve treatment for opioid use disorder (OUD). No specific safety concerns have been identified for this counseling approach. It enhances standard treatment with community-driven and culturally aligned strategies.

This counseling builds on existing practices in medication-assisted treatment (MAT), which people generally tolerate well. The support aims to help individuals remain in treatment and reduce harm from substance use. Although specific safety data is not available, counseling is generally considered safe due to its supportive and non-invasive nature.

Overall, while detailed safety data is lacking, the focus on improving counseling suggests that the treatment is likely well-tolerated. The goal is to help participants stay in treatment and reduce harm from substance use, aligning with practices known to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHaRRM-CN approach for opioid use disorder because it enhances standard treatment by integrating community-driven insights. Unlike typical medication-assisted treatment (MAT) programs, CHaRRM-CN is co-designed with a community advisory board and incorporates feedback from patients and those affected by opioid use disorder. This unique, culturally aligned strategy aims to improve patient retention in treatment by tailoring support to the specific needs of the community, potentially making it more effective and accessible than existing options.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research shows that the CHaRRM-CN program, a treatment option in this trial, might improve outcomes for people with opioid use disorder (OUD). Previous studies have found that similar methods can help patients stay in medication-assisted treatment (MAT) longer and reduce harmful substance use. By aligning with cultural values, CHaRRM-CN aims to strengthen the bond between patients and their community, which is crucial for long-term recovery. Early results suggest that this program could effectively reduce illegal opioid use and support recovery while respecting cultural traditions. Overall, the CHaRRM-CN program offers a promising treatment option for addressing OUD, especially in communities that value cultural connections. ^{1 6 7 8 9}

Who Is on the Research Team?

Lonnie A Nelson, PhD

Principal Investigator

Washington State University

Susan E Collins, PhD

Principal Investigator

University of Washington

Ashley Lincoln, MSW

Principal Investigator

Cherokee Nation Health Services

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05733442

Counseling for Harm Reduction and Retention in ... 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 ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-2023-2a749

CHaRRM Counseling for Opioid Use Disorder It is effective for both opioid use disorder and chronic pain, making it versatile compared to other treatments that may not address both conditions ...

3. reporter.nih.gov reporter.nih.gov/search/V1jUuzNg_Ua4xCfy2-_l5w/project-details/10590442

jordan, ayana - NIH RePORTER The NIH HEAL Initiative bolsters research across NIH to improve treatment for opioid misuse and addiction. Over 100,000 people died from drug overdoses in 2021, ...

4. researchgate.net researchgate.net/publication/387872088_Content_Analysis_of_Perceptions_of_Combined_Pharmacobehavioral_Treatment_for_American_Indian_People_With_Opioid_Use_Disorder

(PDF) Content Analysis of Perceptions of Combined ... In this qualitative study, we document experiences with combined pharmacobehavioral treatment for OUD and suggestions for enhancing it. Method: ...

5. aspe.hhs.gov aspe.hhs.gov/reports/psychosocial-supports-medication-assisted-treatment-site-visit-findings-conclusions-0

Psychosocial Supports in Medication-Assisted Treatment The purpose of this report is to gain a better understanding of the role and range of different models of psychosocial support in medication-assisted treatment ...

6. ireach.wsu.edu ireach.wsu.edu/projects/counseling-for-harm-reduction-and-retention-in-medication-assisted-treatment-at-cherokee-nation-charrm-cn/

Counseling for Harm Reduction and Retention in Medication ... A recent systematic review, however, showed a median retention of 56% at the National Institute on Drug Abuse-recommended 12-month treatment length. Further, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8117118/

Collaborative Care in the Treatment of Opioid Use Disorder ... We hypothesize (1) that relative to patients in AUC, patients in CC will show improvements in six-month rates of opioid use and remission of the co-occurring ...

8. ncsacw.acf.gov ncsacw.acf.gov/files/Collaborative_Approach_508.pdf

A Collaborative Approach to the Treatment of Pregnant ... uses the term “opioid use disorder” to include abuse of or dependence on opioids. ... All CHARM women who receive MAT must also receive substance use disorder ...

9. aspe.hhs.gov aspe.hhs.gov/reports/psychosocial-supports-medication-assisted-treatment-recent-evidence-current-practice-0

Psychosocial Supports in Medication-Assisted Treatment The purpose of this report is to summarize current research findings and describe current practices of psychosocial supports in medication-assisted treatment ( ...