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

NCT05051644 | Completed Phase 1 Results DMC

• 2 other identifiers: NURP-001-21SIK2CX002286
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder; Chronic Pain

Keywords

Chronic Pain; Opioid Use Disorder; opioid agonist treatment; medications for opioid use disorder; methadone; buprenorphine; walking; exercise

Outcome Measures

Primary Outcomes (3)

• Retention

  Treatment retention measured as the number of attended sessions (0-4; higher number is better)

  Up to 5 weeks

• Acceptability

  Credibility measured using the Credibility/Expectancy Questionnaire with separate scores for credibility and expectancy (3-27; higher number is better).

  After the first session, on the same calendar day

• Fidelity

  Fidelity measured as clinician adherence and competence in delivering study interventions using the Yale Adherence and Competence System (1-5; higher number is better).

  Up to 5 weeks

Secondary Outcomes (1)

• Pain Interference

  0-5 weeks

Other Outcomes (1)

• Pain Interference

  3-month and 6-month follow up

Study Arms (2)

Steps 2 Change (S2C)

EXPERIMENTAL

Participants randomized to S2C will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks in the outpatient OAT clinic. Veterans will be expected to increase their average step counts by 10% over their prior week's average. Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain and benefits of activity. Session 2 and 3 will emphasize benefits of low impact physical activity and introduce activity pacing to address pain related to cycles of over activity and subsequent sedentary behavior. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.

Behavioral: Steps 2 Change (S2C)

Control

ACTIVE COMPARATOR

Participants randomized to control will be scheduled for 30-45 minute weekly treatment sessions held over four consecutive weeks focused on problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.

Behavioral: Control

Interventions

Steps 2 Change (S2C) BEHAVIORAL

Session 1 will provide pain education including a discussion the biopsychosocial treatment model for chronic pain. Session 2 and 3 will introduce a progressive walking program with individual goals and weekly step count benchmarks and introduce activity pacing to address pain flare ups caused by cycles of over activity and subsequent sedentary behavior. Veterans will be expected to increase their average step counts by 10% over their prior week's average starting in Session 2. Session 4 will help develop a treatment plan to continue walking and identify possible barriers to meeting goals.

Steps 2 Change (S2C)

Control BEHAVIORAL

The control will be matched for treatment exposure and individual attention. Treatment discussion will explicitly avoid problems associated with MOUD, substance use, and general self-management strategies. Importantly, group will explicitly avoid talking about pain coping skills and setting goals for daily step targets.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. R. Ross MacLean
• Organization: VA Connecticut Healthcare System

robert.maclean@va.gov

203-932-5711

Study Officials

• R. Ross MacLean, PhD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: General terms will be used when recruiting potential participants and in the informed consent. Study title on informed consent and recruitment materials will be "Enhancing self-management skills for individuals with opioid use disorder." Study measures (both in clinic and EMA) will be described as collecting data on problems that Veterans with OUD commonly report (e.g., negative mood, pain, quality of life, stress, etc.) and may improve with increased engagement in treatment. All in person assessment for post-treatment, 3 month follow up, and 6 month follow up will be collected by a research staff member who is blind to study condition. Data from EMA surveys at each time point will be provided by study participant whom is already blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Recruitment strategies will week to minimize the amount of time between screening visit and treatment start date. After completing screening visit, Veterans will begin a 7 day baseline EMA run-in period leading up to the start of the treatment week. First treatment session will be scheduled 7 days after screening visit. The feasibility of these procedures will be evaluated in Aim 1. Veterans who provide pedometer and EMA survey data on at least 3 days during baseline EMA will be randomized. Veterans will be randomized to either S2C or control in a 1:1 ratio using permuted block randomization stratified by OAT type (1=buprenorphine, 2=methadone) and sex (1=male, 2=female). A variable block size of 2 and 4 will be used to maintain balanced assignment to condition.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: April 1, 2022
• Primary Completion: February 28, 2025
• Study Completion: September 30, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 9 months to 36 months after publication of primary findings.
• Access Criteria: Up to 36 months after publication of primary findings, de-identified data can only be used for research purposes with a priori hypotheses including secondary analyses and/or meta-analysis combined with other datasets. Proposals should be directed to robert.maclean@va.gov.

Locations

US (1)