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Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

University of New Mexico (UNM) logo

University of New Mexico (UNM)

Status

Enrolling

Conditions

Opioid Use Disorder
Chronic Pain
Opioid Misuse

Treatments

Behavioral: Implementation Strategies

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06565416
RM1DA055301 (U.S. NIH Grant/Contract)
2303044342
2206007094 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

225 participants in 4 patient groups

Pre-Intervention
No Intervention group
Description:
Baseline prior to any involvement with the project
Intervention
No Intervention group
Description:
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.
Implementation
Active Comparator group
Description:
Evidence-based implementation strategies are put into practice for approximately 6 months.
Treatment:
Behavioral: Implementation Strategies
Sustainment
No Intervention group
Description:
Measuring the degree to which the clinic maintains the implementation phase goals.

Trial contacts and locations

3

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Central trial contact

Angel R Vasquez, PhD; Kamilla L Venner, PhD

Data sourced from clinicaltrials.gov

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