Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

NCT06565416 | Recruiting

• 3 other identifiers: 2303044342RM1DA0553012206007094
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Opioid Use Disorder; Opioid Misuse; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

Pre-Intervention

NO INTERVENTION

Baseline prior to any involvement with the project

Intervention

NO 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.

Implementation

ACTIVE COMPARATOR

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

Behavioral: Implementation Strategies

Sustainment

NO INTERVENTION

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

Interventions

Implementation Strategies BEHAVIORAL

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

Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Clinic Site A (blinded pending tribal approval)

Arcata, California, 95521, United States

RECRUITING

Clinic Site C (blinded pending tribal approval)

Minneapolis, Minnesota, 55404, United States

NOT YET RECRUITING

Clinic Site B (blinded pending tribal approval)

Toppenish, Washington, 98948, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew R Pearson, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamilla L Venner, PhD

CONTACT

5059252300; kamilla@unm.edu

Angel R Vasquez, PhD

CONTACT

vasquez@unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 22, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)