Opioid Use DisorderCHaRRM-CNNCT05733442
Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
A study testing Treatment as usual (TAU) and CHaRRM-CN in people with Opioid Use Disorder, run by Washington State University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Treatment as usual (TAU) and CHaRRM-CN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Washington School of Medicine
Seattle, Washington, 98195
Cherokee Nation Health Services
Tahlequah, Oklahoma, 74464
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Treatment as usual (TAU), CHaRRM-CN
- Keywords
- opioid use disorder, harm reduction, medication assisted treatment, American Indian
- Medical subject headings
- Opioid-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
CHaRRM-CNOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | The TAU condition will entail the current CNHS MAT program for OUD. Receives: Other: Treatment as usual (TAU) |
| CHaRRM-CN | Experimental | 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. Receives: Other: CHaRRM-CN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (5)
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.
Measured: Baseline, month 1, month 3, month 6
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.
Measured: Baseline, month 1, month 3, month 6
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.
Measured: Baseline, month 1, month 3, month 6
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.
Measured: Baseline, month 1, month 3, month 6
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.
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start17 Jan 2023
- Primary completion15 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Cherokee Nation Health Services, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lonnie Nelson, Washington State University
- Investigators
- Lonnie A Nelson, PhD, Principal investigator, Washington State UniversitySusan E Collins, PhD, Principal investigator, University of WashingtonAshley Lincoln, MSW, Principal investigator, Cherokee Nation Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733442
- Sponsor's protocol ID
- CNIRB 337
- Other IDs
- R33DA049376
- Acronym
- CHaRRM-CN
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counseling for Harm Reduction and Retention in Medication-assisted Treatment - Cherokee Nation
- ClinicalTrials.gov ID
- NCT05733442
- Acronym / sponsor ID
- CHaRRM-CN / CNIRB 337
- Conditions
- Opioid Use Disorder
- Keywords
- opioid use disorder, harm reduction, medication assisted treatment, American Indian
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- University of Washington, Cherokee Nation Health Services, National Institute on Drug Abuse (NIDA)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as usual (TAU)The TAU condition will entail the current CNHS MAT program for OUD. |
| CHaRRM-CN | Experimental | Other: CHaRRM-CNThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usual (TAU)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. | Other | Treatment as Usual (TAU) |
| CHaRRM-CNThe 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). | Other | CHaRRM-CN |
Primary outcome
MAT retention
Time frame: Month 6
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.
5 secondary outcomes
Substance-related harm
Time frame: Baseline, month 1, month 3, month 6
Native enculturation
Time frame: Baseline, month 1, month 3, month 6
Native self-reliance
Time frame: Baseline, month 1, month 3, month 6
Illicit Opioid Use
Time frame: Baseline, month 1, month 3, month 6
ED visits
Time frame: Baseline, month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual (TAU) and CHaRRM-CN in people with Opioid Use Disorder, run by Washington State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAT retention (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.