Opioid Use DisorderOPTICNCT06565416
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
A study testing Implementation Strategies in people with Opioid Use Disorder and Opioid Misuse, run by University of New Mexico at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Misuse, Chronic Pain
- What is being tested?
- Implementation Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2023to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Angel R Vasquez, PhD contact
United States3 sites, 3 recruiting
- Recruiting
Clinic Site A (blinded pending tribal approval)
Arcata, California, 95521
Kamilla L Venner, 505-925-2300, kamilla@unm.edu
- Not yet recruiting
Clinic Site C (blinded pending tribal approval)
Minneapolis, Minnesota, 55404
Kamilla L Venner, 505-925-2300, kamilla@unm.edu
- Not yet recruiting
Clinic Site B (blinded pending tribal approval)
Toppenish, Washington, 98948
Kamilla L Venner, 505-925-2300, kamilla@unm.edu
About this study
Official title: 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.
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.
- Conditions
- Opioid Use Disorder, Opioid Misuse, Chronic Pain
- Being tested
- Implementation Strategies
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation StrategiesBehavioural
Culturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Implementation Strategies |
| Sustainment | No intervention | Measuring the degree to which the clinic maintains the implementation phase goals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of clients screened for chronic pain and opioid misuse/opioid use disorder
Derived from electronic medical records
Measured: 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
Measured: 6 months (or duration of sustainment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Matthew R Pearson, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565416
- Sponsor's protocol ID
- 2303044342
- Other IDs
- RM1DA055301, 2206007094
- Acronym
- OPTIC
- Status last verified
- Nov 2026
- First submitted
- 19 Aug 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each Tribal partner has would need to agree to have their data shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial: Implementation of Screening and Brief Intervention
- ClinicalTrials.gov ID
- NCT06565416
- Acronym / sponsor ID
- OPTIC / 2303044342
- Conditions
- Opioid Use Disorder, Opioid Misuse, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Implementation StrategiesEvidence-based implementation strategies are put into practice for approximately 6 months. |
| Sustainment | No intervention | –Measuring the degree to which the clinic maintains the implementation phase goals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- if they have a psychiatric, cognitive, or medical condition that interferes with the consenting process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation StrategiesCulturally centering screening and brief intervention for chronic pain and opioid misuse/opioid use disorder among American Indian/Alaska Native clients | Behavioural | Implementation |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Each Tribal partner has would need to agree to have their data shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angel R Vasquez, PhD contact
Matthew R Pearson, PhD principal investigator
University of New Mexico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Strategies in people with Opioid Use Disorder and Opioid Misuse, run by University of New Mexico at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamilla L Venner, PhD (5059252300, kamilla@unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of clients screened for chronic pain and opioid misuse/opioid use disorder (time frame: 6 months (or duration of implementation phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.