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Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

NCT ID: NCT06565416

Last Updated: 2025-11-12

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2028-07-31

Brief Summary

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The present study seeks to examine the implementation process of culturally tailoring screening and brief intervention for both chronic pain and opioid misuse/opioid use disorder in three American Indian and Alaska Native (AI/AN) serving clinics. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder.

Detailed Description

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Given the health disparities in AI/AN populations and lack of access to quality care for comorbid chronic pain and opioid misuse/OUD, the proposed study seeks to build upon the strong relationships between the research team and the AI/AN communities. There is a dearth of prior research examining chronic pain, opioid misuse/OUD, and other comorbid conditions (mood disorders, anxiety disorders, other SUD) in AI/AN populations. Using CBPR methods, the investigators will work with the OPTIC Collaborative Board to develop a culturally centered implementation intervention to improve screening and brief interventions with AI/AN clients with chronic pain and opioid misuse/OUD (Phase I, Aim 1). Specifically, in collaboration with the community partners and the OPTIC Collaborative Board, the investigators will develop a provider training to increase provider skills and self-efficacy to focus conversations on managing chronic pain (rather than trying to eliminate it) and improving client functioning within cultural frameworks of wellbeing. The goal is to develop, implement, and evaluate culturally centered implementation strategies to increase screening and brief intervention for chronic pain, opioid misuse/OUD in clinics serving AI/AN communities. The investigators will conduct a type III effectiveness-implementation trial over the course of 24 months at each clinical site utilizing EMR data and longitudinal staff surveys to test the implementation outcomes (Phase II, Aim 2) as well as patient surveys to test effectiveness outcomes (Phase II, Aim 3) . The investigators hypothesize that the culturally centered approach will increase rates of screening and brief intervention, and ultimately improve outcomes among AI/AN clients with chronic pain and OUD who receive treatment in primary care. The investigators also will assess staff perspectives on this implementation as well as a survey to understand clients at these sites who have chronic pain and opioid misuse/opioid use disorder for the purpose of identifying areas of treatment needs, and examining the efficacy of a provider-level implementation intervention delivered at the sites from which our participants will be sampled.

Conditions

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Opioid Use Disorder Opioid Misuse Chronic Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A provider-level implementation intervention will be administered at each of the three participating sites. The investigators will examine implementation and effectiveness outcomes before, during, and after implementation.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Given the single group design, it is not feasible to blind investigators or outcomes assessor. Given that the intervention occurs at the site level among providers, patients/clients can be considered blinded given that they are not the direct target of the intervention.

Study Groups

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Intervention

A workgroup for each clinic meets for approximately 6 months to select the specific goals for the clinic to be targeted during the implementation phase.

Group Type NO_INTERVENTION

No interventions assigned to this group

Implementation

Evidence-based implementation strategies are put into practice for approximately 6 months.

Group Type ACTIVE_COMPARATOR

Implementation Strategies

Intervention Type BEHAVIORAL

Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients

Sustainment

Measuring the degree to which the clinic maintains the implementation phase goals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pre-Intervention

Baseline prior to any involvement with the project

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Implementation Strategies

Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide informed consent
* have English comprehension and proficiency
* receiving services at one of our participating study sites
* report current chronic pain and/or opioid misuse/opioid use disorder
* self-identify as American Indian/Alaska Native

Exclusion Criteria

* if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew R Pearson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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Clinic Site A (blinded pending tribal approval)

Arcata, California, United States

Site Status RECRUITING

Clinic Site C (blinded pending tribal approval)

Minneapolis, Minnesota, United States

Site Status NOT_YET_RECRUITING

Clinic Site B (blinded pending tribal approval)

Toppenish, Washington, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Kamilla L Venner, PhD

Role: CONTACT

Phone: 5059252300

Email: [email protected]

Angel R Vasquez, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Kamilla L Venner

Role: primary

Kamilla L Venner

Role: primary

Kamilla L Venner

Role: primary

Other Identifiers

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RM1DA055301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2206007094

Identifier Type: OTHER

Identifier Source: secondary_id

2303044342

Identifier Type: -

Identifier Source: org_study_id