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Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities

Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04958798
Acronym
CTN-0096
Enrollment
2059
Registered
2021-07-12
Start date
2021-12-20
Completion date
2025-01-16
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder

Keywords

American Indian, Alaska Native, Medications for Opioid-use Disorder, Implementation, Cultural centering

Brief summary

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities.

Detailed description

This is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (MOUD) in four healthcare and addiction specialty treatment sites serving American Indian and Alaska Native communities. The study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (N=4 sites). Study design and methods are informed by the Consolidated Framework for Implementation Research (CFIR) and the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The primary outcome of the trial is the number of consumers with OUD initiated onto MOUD (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention Reach. The primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). Primary data collection will use de-identified data from the electronic medical records (EMR) at each site beginning with data from the six months prior to intervention delivery for Step 1 sites and 12 months prior for Step 2 sites. For Step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation) but this will be exploratory. As part of the study, consumers with OUD will be asked to participate in additional assessments and provide informed consent. Enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of OUD treatment. Providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to MOUD.

Interventions

BEHAVIORALCulturally Centered MOUD Implementation Intervention

Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER
University of New Mexico
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

All sites (N=4) started in standard/usual care and then were randomly assigned to receive the program level implementation intervention in sequence 1 (2 sites) or sequence 2 (2 sites).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Receiving services at a participating study site * Meet criteria for a current opioid use disorder * Identify as American Indian or Alaska Native * 18 years or older

Exclusion criteria

* Not Applicable

Design outcomes

Primary

MeasureTime frameDescription
Number of Consumers With OUD Initiated Onto MOUDPre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.

Secondary

MeasureTime frameDescription
Number of Consumers With OUD Retained in CarePre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods.
Number of Consumers Screened for OUDPre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods.

Countries

United States

Participant flow

Recruitment details

De-identified electronic medical record (EMR) data from N=4 sites was collected. There was no direct client recruitment needed for the primary and secondary analyses.

Pre-assignment details

Staff participants (who completed anonymous cross-sectional surveys) were not enrolled into study arms.

Baseline characteristics

Characteristic
Age, Continuous37.0 Years
STANDARD_DEVIATION 11.9
Ethnicity (NIH/OMB)
Hispanic or Latino
74 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
112 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
198 Participants
Sex: Female, Male
Female
714 Participants
Sex: Female, Male
Male
81 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026