Phase 1 N=60 Randomized Double-blind Treatment

An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment

Opioid Use Disorder · Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT05051644 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Feb 2026

Primary outcome: Primary: Retention — 3.7; 3.6 number of sessions attended

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Steps 2 Change (S2C) (Behavioral); Control (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Retention	3.7; 3.6	—
PRIMARY Acceptability	18.7; 20.2; 15.7; 15.9	—
PRIMARY Fidelity	3.1; 3.2	—
SECONDARY Pain Interference	1.0; 0.9; 1.2; 0.9	—

Summary

Severe chronic pain and opioid use disorder (OUD) occur at significantly higher rates in Veterans compared to the general population. Chronic pain often persists despite engagement in opioid agonist treatment (OAT), the first line treatment for OUD. Recent VA guidelines strongly recommend non-pharmacologic treatment for chronic pain, but individuals with OUD are frequently excluded from pain treatment studies. There is a need for evidence-based pain treatments that compliment OAT for Veterans with chronic pain and OUD. In this study, the investigators will determine feasibility and acceptability for a behaviorally focused pain treatment that includes pain education and a pedometer assisted adaptive walking program for Veterans receiving OAT for OUD. Potential treatment outcomes will be repeatedly assessed using a mobile device, and study-provided pedometers. By offering pain treatment within OAT clinical care, the investigators hope to decrease stigma and increase access for Veterans with chronic pain and OUD.

Eligibility Criteria

Inclusion Criteria

Meet DSM5 criteria for OUD and receiving stable (i.e., unchanged in 2 weeks) dose of OAT (i.e., buprenorphine or methadone) in VACHS outpatient addiction clinic
Report high impact or bothersome chronic pain defined by experiencing pain on most days or every day in the past 3 months that limits general activity or enjoyment
Self-reported ability to walk 1 block
Access to a mobile phone with active data plan

Exclusion Criteria

Untreated major psychiatric disorders (e.g., bipolar disorder, psychotic disorder)
Current (i.e., past month) active suicidal ideation
Substance use disorder requiring inpatient detoxification
Currently engaged in CBT for chronic pain treatment
Planned surgical intervention for pain

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05051644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.