Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
2 other identifiers
interventional
250
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2026
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
November 2, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2029
Study Completion
Last participant's last visit for all outcomes
May 31, 2030
January 28, 2026
January 1, 2026
2.6 years
January 14, 2026
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PROMIS Pain Interference 6b
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 Outcomes (7)
PROMIS Pain Interference 6b
6- and 9-months post randomization
Veterans Rand 12-Item Health Survey (VR-12)
3-months post-randomization
Activity Measure for Post-Acute Care (AM-PAC)
3-months post-randomization
PROMIS Sleep Disturbance 6a and Duration
3-months post randomization
Buprenorphine retention
3-months post randomization
- +2 more secondary outcomes
Study Arms (2)
IMPACT
EXPERIMENTALData from Veteran participants randomized to digital intervention (IMPACT)
ETAU
PLACEBO COMPARATORData from Veteran participants randomized to ETAU (no access to IMPACT)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
R. Ross MacLean, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2026
First Posted
January 23, 2026
Study Start (Estimated)
November 2, 2026
Primary Completion (Estimated)
June 3, 2029
Study Completion (Estimated)
May 31, 2030
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF