Clinical trial NCT05733442: Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
Official title: Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
harm reduction
medication assisted treatment
American Indian
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Cherokee Nation Health Services
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-02-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The opioid epidemic disproportionately impacts the American Indian (AI) population, which experiences an 88% higher prevalence of OUDs (1.5%) than the US general population (0.8%). The AI population is second only to non-Latinx whites in their experience of opioid overdose deaths (13.9 and 17.5 per 100,000, respectively). Fortunately, medication-assisted treatment (MAT; e.g., buprenorphine + naloxone) is highly effective for reducing opioid-related harm, including overdose, making it the gold-standard OUD treatment approach. A systematic review showed a median retention of 56% at the NIDA-recommended 12-month treatment length. However, most AI people with OUD do not attend traditional substance-use treatment (62%). This is concerning because treatment retention is strongly associated with a mortality rate reduction. Although no studies have documented OUD treatment outcomes specific to AI patients, research in Native communities has generally highlighted concerns about the cultural acceptability of the highly directive, Western medical substance-use treatment approaches (e.g., cognitive-behavioral therapy, 12-step programming) that are widely available. Further, previous research has indicated that AI patients with substance use disorders want greater representation of Native staff and better integration of culturally adapted approaches in the services they receive. Culturally adapted approaches to treatment are associated with reductions in use and associated harm. However, there are currently no evidence-based, culturally adapted counseling approaches for AI patients addressing MAT retention and opioid-related harm. Accordingly, the investigators are conducting a 2-phase R61/R33 development and evaluation project. The 2-year R61 Phase has been completed and entailed two parts. First, the investigators conducted a mixed methods inquiry to inform research methods and to create a community-specific, cultural adaptation of an existing, efficacious, harm-reduction counseling approach. Second, the investigators co-created and manualized the resulting Counseling for Harm Reduction and Retention in MAT at Cherokee Nation (CHaRRM-CN) together with a community advisory board comprising CNHS providers, staff, and patients as well as researchers from Cherokee Nation, Washington State University, and the University of Washington. The current, 3-year R33 Phase entails a 2-arm RCT (N=136) conducted within CNHS testing the efficacy of CHaRRM-CN in improving 6-month MAT retention, reducing substance-related harm and illicit opioid use, and increasing Native enculturation compared to a treatment-as-usual control condition.

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

Primary outcomes:
measure: MAT retention
timeFrame: Month 6
Secondary outcomes:
measure: Substance-related harm
timeFrame: Baseline, month 1, month 3, month 6
measure: Native enculturation
timeFrame: Baseline, month 1, month 3, month 6
measure: Native self-reliance
timeFrame: Baseline, month 1, month 3, month 6
measure: Illicit Opioid Use
timeFrame: Baseline, month 1, month 3, month 6
measure: ED visits
timeFrame: Baseline, month 6
Other outcomes:
measure: Health-related quality of life (HR-QoL)
timeFrame: Baseline, month 1, month 3, month 6
Locations:
city: Tahlequah
country: United States
facility: Cherokee Nation Health Services
state: Oklahoma
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Washington State University
name: Lonnie A Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Susan E Collins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cherokee Nation Health Services
name: Ashley Lincoln, MSW
role: PRINCIPAL_INVESTIGATOR
References: