Pain and Opioids: Integrated Treatment In Veterans (POSITIVE)

December 18, 2025 updated by: University of New Mexico

Integrated Treatment for Veterans With Co-Occurring Chronic Pain and Opioid Use Disorder

This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention [ACT + MBRP]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is compelling data that chronic pain and hazardous opioid use, considered individually, are significant and costly healthcare burdens in both veteran and nonveteran populations in the United States (US). When these two diagnoses are considered together, they appear to occur in a clinically significant proportion of patients. Further, opioid use disorder (OUD) interferes with chronic pain treatment outcomes and continued pain interferes with OUD outcomes treatment. While buprenorphine is effective for the treatment of pain and OUD, retention, relapse, and continued pain interference is not addressed through treatment with buprenorphine alone. Integrated treatments that target the key outcomes for both conditions, specifically pain's interference on functioning and opioid misuse/relapse, as developed in our prior work, allows for a parsimonious and efficacious way of providing treatment. Our recently completed pilot study indicated that such an integrated treatment was feasible and more effective than treatment as usual. To study this further, a multisite clinical trial comparing a three month integrated behavioral treatment that combines Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention, as compared to an education control will be conducted with 160 veterans recruited from three VA Health Care Systems who have been stabilized on buprenorphine for the treatment of OUD. To assess longer-term outcomes, participants will be followed for 1 year after completion of the 3 month intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Katie A Witkiewitz, PhD
  • Phone Number: 12062262965
  • Email: katiew@unm.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Health Care System
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • New Mexico VA Healthcare System
    • Washington
      • Tacoma, Washington, United States, 98493
        • Puget Sound VA Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Stabilized on a dose of buprenorphine for a period of at least 1 month and less than six months. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
  2. Willing to comply with all study procedures and be available for the duration of the study
  3. Male or female, aged 21 to 75 years.
  4. Enrolled as a patient in one of the participating VA Co-Occurring Disorders clinics.
  5. Presence of chronic pain for > 6 months in duration.

Exclusion Criteria:

  1. Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
  2. Unable to read English.
  3. Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT + MBRP
Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) group will follow a manualized clinical protocol. Treatment will include 12 weekly group-based sessions, each lasting 90 minutes. Group sizes will range from 3 to 8. ACT + MBRP will be delivered via the VA Video Connect telehealth platform.
Behavioral: ACT+MBRP
Intervention is behavioral treatment group that combines Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention. The group focuses on living with long-term pain, ways to complete daily living activities when you experience pain, coping with opioid and other drug cravings, and training in mindfulness practices.
Active Comparator: Education Control (EC)
The EC group will follow a protocol that combines opioid education sessions and psychology-led pain education sessions that are offered as part of the interdisciplinary pain program. Specifically, education will include 12 group-based sessions, each lasting 60 to 90 minutes. Group sizes will range from 3 to 8. EC will be delivered via the VA Video Connect telehealth platform.
Behavioral: Education control
Education control is behavioral treatment group that combines pain patient education with opioid and other drug education. The group focuses on experiences of long-term pain, instructions on how to function with this pain, and facts about opioids and other drugs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain interference
Time Frame: Post-Treatment (month 3)
Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items.
Post-Treatment (month 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid misuse
Time Frame: Post-Treatment (month 3)
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Post-Treatment (month 3)
Pain intensity
Time Frame: Post-Treatment (month 3)
Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale.
Post-Treatment (month 3)
Change in pain intensity
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain intensity, including current and least/most/usual over the past week, will be assessed via a 0 (no pain) to 10 (maximum possible pain) Numerical Rating Scale.
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Depression
Time Frame: Post-Treatment (month 3)
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
Post-Treatment (month 3)
Change in depression
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Patient Health Questionnaire 9 (PHQ-9) - The PHQ-9 will be used to assess depression via 9 self-report items.
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain-related Fear
Time Frame: Post-Treatment (month 3)
Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items.
Post-Treatment (month 3)
Change in pain-related Fear
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain Anxiety Symptom Scale (PASS) - Pain-related fear is reliably related to increased pain-related distress and disability via 20 self-report items.
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Alcohol and other drug use
Time Frame: Post-Treatment (month 3)
Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance).
Post-Treatment (month 3)
Change in alcohol and other drug use
Time Frame: Monthly.
Substance use over the past 7 days will be assessed via the Timeline Followback. Number of drinking days, number of days misusing substances, number of days of polysubstance use (using more than one substance), and drinks per drinking day will be calculated based on the number of days of drinking, number of days of substance misuse (where substance misuse is defined as non-prescribed opioids, non-prescribed other prescription drugs, illicit substances, and heavy drinking (4 or more drinks for women, 5 or more drinks for men)), and number of days of polysubstance use (defined as using more than one substance).
Monthly.
Change in Pain interference
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference- The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference will be assessed via 8 items.
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Change in opioid misuse
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Current Opioid Misuse Measure (COMM) - The COMM measures opioid misuse risk and opioid-related behaviors via 17 items.
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social role functioning
Time Frame: Post-Treatment (month 3)
PROMIS, Social Role Functioning via 8 self-report items.
Post-Treatment (month 3)
Change in social role functioning
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Social Role Functioning via 8 self-report items.
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Psychosocial Impact of Illness
Time Frame: Post-Treatment (month 3)
PROMIS, Psychosocial Impact of Illness via 8 self-report items
Post-Treatment (month 3)
Change in psychosocial Impact of Illness
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Psychosocial Impact of Illness via 8 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Physical Functioning
Time Frame: Post-Treatment (month 3)
PROMIS, Physical Functioning via 6 self-report items
Post-Treatment (month 3)
Change in Physical Functioning
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Physical Functioning via 6 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Alcohol Use
Time Frame: Post-Treatment (month 3)
Alcohol Use Disorders Identification Test, 10 self-report items
Post-Treatment (month 3)
Change in Alcohol Use
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Alcohol Use Disorders Identification Test, 10 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Post-Traumatic Disorder Symptoms
Time Frame: Post-Treatment (month 3)
PTSD Checklist-5, 20 self-report items
Post-Treatment (month 3)
Change in Post-Traumatic Disorder Symptoms
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PTSD Checklist-5, 20 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Generalized Anxiety
Time Frame: Post-Treatment (month 3)
Generalized Anxiety Disorders Test (GAD-7), 7 self-report items
Post-Treatment (month 3)
Change in Generalized Anxiety
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Generalized Anxiety Disorders Test (GAD-7), 7 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Sleep Disturbance
Time Frame: Post-Treatment (month 3)
PROMIS, Sleep Disturbance via 6 items
Post-Treatment (month 3)
Change in Sleep Disturbance
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
PROMIS, Sleep Disturbance via 6 items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain Catastrophizing
Time Frame: Post-Treatment (month 3)
Pain Catastrophizing Scale - Short Form, 6 self-report items
Post-Treatment (month 3)
Change in Pain Catastrophizing
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Pain Catastrophizing Scale - Short Form, 6 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Substance use
Time Frame: Post-Treatment (month 3)
Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items
Post-Treatment (month 3)
Change in Substance use
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Tobacco, Alcohol, Prescription medication, and other Substance use Tool, 5 self-report items
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Patient Global Impression of Change
Time Frame: Post-Treatment (month 3)
Patient Global Impression of Change (PGIC) is a one item measure that reflects a patient's belief about the efficacy of treatment on a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Post-Treatment (month 3)
Change in Patient Global Impression of Change
Time Frame: Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups
Patient Global Impression of Change (PGIC) is a one item measure that reflects a patient's belief about the efficacy of treatment on a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Pretreatment (month 0), post-treatment (month 3), and 6 and 12 month follow ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Duke University
University of California, San Francisco
Vanderbilt University
Queen's University, Belfast
University of Utah
Seattle Institute for Biomedical and Clinical Research
Biomedical Research Institute of New Mexico
San Francisco VA Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1507090
  • 1UG3DA051241-01 (U.S. NIH Grant/Contract)
  • A20-0217 (Other Identifier: Cayuse Project Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is expected that all data collected by award recipients and their collaborators, as part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding.

IPD Sharing Time Frame

At the time of publication of the primary manuscript, or within 12 months of last patient procedure

IPD Sharing Access Criteria

Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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