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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2025-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mobile Mindfulness Training (mMT) for People in Medication Treatment of Opioid Use Disorder (MOUD)

NCT06857968

Opioid Use Disorder

ENROLLING_BY_INVITATION NA

Opioid Treatment and Peer Recovery Support

NCT04978168

Opioid-use Disorder

RECRUITING NA

Evaluation of a Medication Health Center to Promote Opioid Safety

NCT06456294

Overdose

ACTIVE_NOT_RECRUITING NA

Piloting a Patient-Reported Outcome Measure for Opioid Use Disorder Recovery in a Clinical Setting

NCT05388045

Substance Use Disorders Opioid Use Disorder

UNKNOWN NA

Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

NCT04248933

Substance Use Substance Use Disorders Opioid-use Disorder +5 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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). 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid-use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Culturally Centered MOUD Implementation

Culturally centered program-level implementation intervention to increase the use of medications for opioid use disorder in healthcare and treatment settings serving AI/AN communities

Group Type EXPERIMENTAL

Culturally Centered MOUD Implementation Intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Culturally 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to provide informed consent
* English comprehension and proficiency
* Receiving services at a participating study site
* Meet criteria for a current opioid use disorder
* Self-identify as American Indian or Alaska Native
* Willing to have program data linked to assessment data
* 18 years or older