Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine

January 27, 2026 updated by: VA Office of Research and Development

Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine

Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

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 Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
        • Contact:
        • Principal Investigator:
          • R. Ross MacLean, PhD
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730-1114
        • VA Bedford HealthCare System, Bedford, MA
        • Contact:
      • Boston, Massachusetts, United States, 02130-4817
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • VA Portland Health Care System, Portland, OR
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • an ICD-11 OUD diagnosis in the VHA electronic health record (EHR)
  • receipt of buprenorphine from outpatient addiction clinic with stable (i.e., unchanged in 2 weeks or since last injection) dose confirmed by the prescribing clinician. Both oral and injectable buprenorphine formulations will be eligible with dose stabilization required to isolate chronic pain from withdrawal-related pain associated with non-therapeutic dose
  • presence of musculoskeletal pain that is bothersome or high-impact per the Graded Pain Scale - Revised
  • access to a web-connected device to complete daily surveys and connect to IMPACT treatment site
  • ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block

Exclusion Criteria:

  • dementia-related EHR diagnosis
  • participant-reported vision or hearing impairments that would preclude use of the IMPACT system
  • legal actions that would make study completion unlikely
  • current or past 12 month engagement in CBT for chronic pain treatment
  • planned surgical intervention for pain
  • physical or mental health conditions that would interfere with ability to meaningful engage in IMPACT and MOUD treatment (e.g., uncontrolled bipolar disorder, active suicidal ideation, receipt of hospice or end-of-life palliative care)

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMPACT
Data from Veteran participants randomized to digital intervention (IMPACT)
Behavioral: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)
The IMPACT program is a 9-module web-based treatment augmented with personalized weekly feedback from an expert coach for people with chronic pain and OUD receiving MOUD.
Placebo Comparator: ETAU
Data from Veteran participants randomized to ETAU (no access to IMPACT)
Behavioral: Enhanced Treatment as Usual (ETAU)
ETAU is inclusive of medication management, groups, and individual treatment offered within the outpatient buprenorphine clinics at the study sites. Additionally, study staff will provide a a comprehensive list of pain, addiction and mental health treatment options that are specific to their VA facility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Pain Interference 6b
Time Frame: 3-months post-randomization
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference).
3-months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Pain Interference 6b
Time Frame: 6- and 9-months post randomization
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less pain interference).
6- and 9-months post randomization
Veterans Rand 12-Item Health Survey (VR-12)
Time Frame: 3-months post-randomization
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to better quality of life).
3-months post-randomization
Activity Measure for Post-Acute Care (AM-PAC)
Time Frame: 3-months post-randomization
Measure has two scales: Basic Mobility (range: 0-24) and Daily Activity (range: 0-24); on both scales higher scores corresponds to better performance.
3-months post-randomization
PROMIS Sleep Disturbance 6a and Duration
Time Frame: 3-months post randomization
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less sleep disturbance).
3-months post randomization
Buprenorphine retention
Time Frame: 3-months post randomization
retention is defined as both continuous and verified enrollment in MOUD in the 30 days prior to the specified timepoint. Continuous will be defined as having a continuously active buprenorphine prescription with a record of dispensing that includes the prior 30 days verified by Electronic Health Record. Retention will be a binary outcome with 1 = retained (conditions met) and 0 = not retained
3-months post randomization
Buprenorphine adherence
Time Frame: 3-months post randomization
Timeline Follow-back will collect days of use for buprenorphine since last time point. During treatment period, weekly Timeline Follow-back adherence to buprenorphine will be compared to daily surveys and active buprenorphine prescription will be verified in Electronic Health Record (EHR). If a participant does not complete Timeline Follow-Back and/or has missing data in daily surveys or did not pick up buprenorphine as prescribed in EHR, the week will be considered non-adherent. Injectable buprenorphine will be verified in EHR and, if participant received injection as scheduled, they will be considered adherent. Mean adherent weeks will be calculated in each group; higher number corresponds to greater adherence.
3-months post randomization
Non-prescribed opiate use
Time Frame: 3-months post randomization
Timeline Follow-back will collect days of non-prescribed opiate use since last time point. Weekly Timeline Follow-back non-prescribed opiate use will be collected during treatment period. Mean days of non-prescribed opiate use in a week will be calculated in each group; higher number corresponds to greater non-prescribed opiate use.
3-months post randomization

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: R. Ross MacLean, PhD, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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 (Estimated)

November 2, 2026

Primary Completion (Estimated)

June 3, 2029

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRDA-001-25M
  • 1I01RD000376-01A1 (Other Grant/Funding Number: ORD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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