ClinicalTrials.gg
RecruitingNCT06565416OPTICUpdated Nov 6, 2026

Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial

An interventional study of Implementation Strategies in Opioid Use Disorder, Opioid Misuse and Chronic Pain, sponsored by University of New Mexico. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2023, registered Aug 2024).
  • Started Jun 2023; still recruiting 3 years 5 months later.
Updated Nov 6, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Opioid Use Disorder
  • Opioid Misuse
  • Chronic Pain
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 225 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing and able to provide
  • 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

Exclusion Criteria:

  • if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
225 participants (estimated)

Study arms

  • 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

  • No intervention
    Sustainment

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

Interventions

  • BehavioralImplementation Strategies

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

06

What researchers measure

Primary outcomes

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

    Derived from electronic medical records

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

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

    Derived from electronic medical records

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

07

Study locations

1 of 3 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No — Each Tribal partner has would need to agree to have their data shared.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Oct 2026→Dec 2026
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Primary completion Oct 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06565416
Responsible party
Sponsor
First posted
Aug 22, 2024
Start date
Jun 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Jul 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

Kamilla L Venner, PhD
Contact
kamilla@unm.edu
5059252300
Angel R Vasquez, PhD
Contact
vasquez@unm.edu
Matthew R Pearson, PhD
principal investigator · University of New Mexico

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion