search
Back to results

Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation (CHaRRM-CN)

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment as usual (TAU)
CHaRRM-CN
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring opioid use disorder, harm reduction, medication assisted treatment, American Indian

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years of age 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). Must be willing to provide written informed consent to enroll in this study Exclusion Criteria: Refusal or inability to consent to participation in research. (The latter is assessed using the UCSD Brief Assessment of Capacity to Consent.) Refusal or inability to consent and constituting a risk to the safety and security of other patients or staff

Sites / Locations

  • Cherokee Nation Health ServicesRecruiting
  • University of Washington School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as Usual (TAU)

CHaRRM-CN

Arm Description

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

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.

Outcomes

Primary Outcome Measures

MAT retention
MAT program retention is defined by an active prescription for buprenorphine+naloxone with no gaps ≥ 30 days at month 6. This measure will dichotomously indicate whether participants have been retained in the MAT program (1) or not (0) at month 6.

Secondary Outcome Measures

Substance-related harm
The Short Inventory of Problems will be used to collect data on substance-related harm in the past month. The range of possible scores on the single summary score is 0-45, and higher scores indicate a greater experience of substance-related harm. Change will be measured across the 4 points listed in the time frame.
Native enculturation
The Cultural Connectedness Scale - Short Version is a 10-item Likert type measure consisting of 3 dimensions: identity, traditions, and spirituality. Criterion validity was demonstrated with cultural connectedness dimensions adequately correlating with other indicators of wellness. Greater scores indicate greater cultural connectedness. Change will be measured across the 4 points listed in the time frame.
Native self-reliance
The Cherokee Self-Reliance Questionnaire includes 24, Likert-scale items that have been psychometrically validated in previous research.60,61 Consistent with the Cherokee self-reliance concept, the instrument comprises 3 factors: being responsible, disciplined, and confident. The higher the scale scores the higher the Native self-reliance. Change will be measured across the 4 points listed in the time frame.
Illicit Opioid Use
The Timeline Followback (TLFB) uses calendars for a retrospective evaluation of daily substance use. Meta-analyses have indicated the TLFB is a psychometrically sound way to detect substance use, including opioid use, across various populations and study designs. In the proposed study, the TLFB will be primarily used to assess use of illicit opioids. Change will be measured across the 4 points listed in the time frame.
ED visits
CNHS ED administrative data to assess number of visits to the ED both 6-months pre- and post-study enrollment. Change will be measured between the 2 points listed in the time frame.

Full Information

First Posted
January 30, 2023
Last Updated
February 15, 2023
Sponsor
Washington State University
Collaborators
University of Washington, Cherokee Nation Health Services, National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05733442
Brief Title
Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
Acronym
CHaRRM-CN
Official Title
Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
University of Washington, Cherokee Nation Health Services, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (N=160) 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=160) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
opioid use disorder, harm reduction, medication assisted treatment, American Indian

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
The TAU condition will entail the current CNHS MAT program for OUD.
Arm Title
CHaRRM-CN
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
TAU entails medication to support patients' recovery (i.e., the partial opioid agonist, buprenorophine + naloxone/ Suboxone gel films), in-person case management and behavioral health intervention (i.e., in-person group and individual counseling), and referrals to other health care and behavioral health services.
Intervention Type
Other
Intervention Name(s)
CHaRRM-CN
Intervention Description
The CHaRRM-CN intervention includes changes and additions to TAU to make MAT more culturally aligned (i.e., offering regular community-based, cultural programming; offering culturally aligned healing groups in the MAT program, such as Talking Circles and beading group) as well as lower barrier and incentivized (i.e., offering medication and behavioral health appointments via in-person, videoconference or telephone; offering harm-reduction groups in addition to abstinence-based groups; providing mailed and in-person pick-up options for buprenorphine prescriptions; conducting weekly chart reviews to ensure prescriptions and basic needs are continuously met; bimonthly, automated text outreach; contingency management supporting attendance at in-person or telehealth appointments).
Primary Outcome Measure Information:
Title
MAT retention
Description
MAT program retention is defined by an active prescription for buprenorphine+naloxone with no gaps ≥ 30 days at month 6. This measure will dichotomously indicate whether participants have been retained in the MAT program (1) or not (0) at month 6.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Substance-related harm
Description
The Short Inventory of Problems will be used to collect data on substance-related harm in the past month. The range of possible scores on the single summary score is 0-45, and higher scores indicate a greater experience of substance-related harm. Change will be measured across the 4 points listed in the time frame.
Time Frame
Baseline, month 1, month 3, month 6
Title
Native enculturation
Description
The Cultural Connectedness Scale - Short Version is a 10-item Likert type measure consisting of 3 dimensions: identity, traditions, and spirituality. Criterion validity was demonstrated with cultural connectedness dimensions adequately correlating with other indicators of wellness. Greater scores indicate greater cultural connectedness. Change will be measured across the 4 points listed in the time frame.
Time Frame
Baseline, month 1, month 3, month 6
Title
Native self-reliance
Description
The Cherokee Self-Reliance Questionnaire includes 24, Likert-scale items that have been psychometrically validated in previous research.60,61 Consistent with the Cherokee self-reliance concept, the instrument comprises 3 factors: being responsible, disciplined, and confident. The higher the scale scores the higher the Native self-reliance. Change will be measured across the 4 points listed in the time frame.
Time Frame
Baseline, month 1, month 3, month 6
Title
Illicit Opioid Use
Description
The Timeline Followback (TLFB) uses calendars for a retrospective evaluation of daily substance use. Meta-analyses have indicated the TLFB is a psychometrically sound way to detect substance use, including opioid use, across various populations and study designs. In the proposed study, the TLFB will be primarily used to assess use of illicit opioids. Change will be measured across the 4 points listed in the time frame.
Time Frame
Baseline, month 1, month 3, month 6
Title
ED visits
Description
CNHS ED administrative data to assess number of visits to the ED both 6-months pre- and post-study enrollment. Change will be measured between the 2 points listed in the time frame.
Time Frame
Baseline, month 6
Other Pre-specified Outcome Measures:
Title
Health-related quality of life (HR-QoL)
Description
The EuroQoL-5 Dimensional-5 Level (EQ-5D-5L) is a standardized 5-item, 5-point Likert-type measure of health-related QoL. This widely used, easily administered and psychometrically sound measure comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Additionally, a single, 100-point vertical visual analogue scale serves as a quantitative measure of participants' self-reported overall health status. The higher the scores, the higher the HR-QoL. This is an exploratory measure. Change will be measured across the 4 points listed in the time frame.
Time Frame
Baseline, month 1, month 3, month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age 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). Must be willing to provide written informed consent to enroll in this study Exclusion Criteria: Refusal or inability to consent to participation in research. (The latter is assessed using the UCSD Brief Assessment of Capacity to Consent.) Refusal or inability to consent and constituting a risk to the safety and security of other patients or staff
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan E Collins, PhD
Phone
2068327885
Email
susan.collins@wsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lonnie A Nelson, PhD
Phone
5734240888
Email
lonnie.nelson@wsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonnie A Nelson, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan E Collins, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Taylor, MS
Organizational Affiliation
Cherokee Nation Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cherokee Nation Health Services
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Taylor, MS
Phone
539-234-3500
Email
mark-taylor@cherokee.org
First Name & Middle Initial & Last Name & Degree
Terrence K Kominsky, PhD
Phone
(918) 207-4984
Email
terrence-kominsky@cherokee.org
First Name & Middle Initial & Last Name & Degree
Mark Taylor, MS
First Name & Middle Initial & Last Name & Degree
Terrence Kominsky, PhD
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation

We'll reach out to this number within 24 hrs