Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial (OPTIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Opioid Use Disorder; Opioid Misuse
• Intervention / Treatment: Behavioral: Implementation Strategies

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamilla L Venner, PhD; Phone Number: 5059252300; Email: kamilla@unm.edu
• Study Contact Backup: Name: Angel R Vasquez, PhD; Email: vasquez@unm.edu

Study Locations

• United States
  • California
    • Arcata, California, United States, 95521
      • Recruiting
      • Clinic Site A (blinded pending tribal approval)
      • Contact: Kamilla L Venner; Phone Number: 505-925-2300; Email: kamilla@unm.edu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Not yet recruiting
      • Clinic Site C (blinded pending tribal approval)
      • Contact: Kamilla L Venner; Phone Number: 505-925-2300; Email: kamilla@unm.edu
  • Washington
    • Toppenish, Washington, United States, 98948
      • Not yet recruiting
      • Clinic Site B (blinded pending tribal approval)
      • Contact: Kamilla L Venner; Phone Number: 505-925-2300; Email: kamilla@unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-Intervention; Baseline prior to any involvement with the project
No Intervention: 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.
Active Comparator: Implementation; Evidence-based implementation strategies are put into practice for approximately 6 months.	Behavioral: Implementation Strategies; Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients
No Intervention: Sustainment; Measuring the degree to which the clinic maintains the implementation phase goals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of clients screened for chronic pain and opioid misuse/opioid use disorder	Derived from electronic medical records	6 months (or duration of implementation phase)
Number of clients screened for chronic pain and opioid misuse/opioid use disorder	Derived from electronic medical records	6 months (or duration of sustainment phase)

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Matthew R Pearson, PhD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Opioid-Related Disorders; Chronic Pain
• Other Study ID Numbers: 2303044342; RM1DA055301 (U.S. NIH Grant/Contract); 2206007094 (Other Identifier: University of New Mexico)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Each Tribal partner has would need to agree to have their data shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No