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NCT Number: NCT06565416

Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic Site A (blinded pending tribal approval), Arcata, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation strategies

Behavioral

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

Primary outcomes

  1. Number of clients screened for chronic pain and opioid misuse/opioid use disorder

    Time frame: 6 months (or duration of implementation phase)

    Derived from electronic medical records

  2. Number of clients screened for chronic pain and opioid misuse/opioid use disorder

    Time frame: 6 months (or duration of sustainment phase)

    Derived from electronic medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Angel R Vasquez, PhD

CONTACT

[email protected]

Kamilla L Venner, PhD

CONTACT

[email protected]

5059252300

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial: Implementation of Screening and Brief Intervention

Acronym: OPTIC

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 22, 2024
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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