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

February 2, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

The proposed study will address the pain treatment knowledge gap in Veterans with opioid use disorder (OUD) by piloting a behaviorally-based walking pain treatment for Veterans with chronic pain and OUD. Steps to Change (S2C) is a pain-focused treatment comprised of brief weekly 30-45-minute treatment sessions held over four consecutive weeks within the a Veterans Health Administration opioid agonist treatment (OAT) clinic. To date, no study has evaluated a pedometer-assisted walking program in individuals with chronic pain and OUD engaged in OAT. Topics for S2C include biopsychosocial pain education, pacing activities, benefits of physical activity, and an adaptive walking program derived from Cognitive Behavioral Therapy for chronic pain (CBT-CP) modules. The control will be matched for treatment exposure and attention. Veterans in both conditions will be provided a pedometer to record daily step counts as an objective measure of physical activity. Importantly, pain is a dynamic process that is known to vary over time and context. Veterans in both conditions will complete ecological momentary assessment (EMA) surveys, where behavior is repeatedly sampled using a mobile device.

The study objectives align closely with the description of a Stage IB pilot trial. Stage IB research determines feasibility and pilot testing of an adaptation or refinement of an existing intervention. Walking is a core component of CBT-CP and physical activity has a strong evidence base as a pain treatment for individuals with chronic pain; however, a walking program for chronic pain has not been evaluated in Veterans with chronic pain and OUD receiving OAT. Aim 1 will determine feasibility of study procedures including randomization, retention, fidelity, and proposed study outcomes of S2C and control conditions. Evaluating the feasibility of treatment and best practices for how quickly Veterans can be screened, consented, and randomized to start treatment is a critical step to inform a larger Stage II efficacy trial. In addition, the investigators will evaluate treatment attendance and retention in both S2C and control conditions to determine feasibility as well as discrimination of conditions for fidelity. The investigators will also collect data on mobile phone ownership and compare EMA survey response rates between conditions to inform future efficacy studies. The investigators expect that treatment attendance, retention, and survey responses for S2C will be equal to or superior then control. Aim 2 will establish acceptability of S2C and health education control by assessing intervention credibility and satisfaction at post-treatment. The investigators expect that Veterans in both conditions will report treatment as credible and satisfying. Finally, Aim 3 will evaluate preliminary evidence for whether S2C, compared to control, reduces pain interference assessed via interference items on the PEG. Primary endpoint will be at post-treatment, but the investigators will also evaluate durability or sleeper effects on pain interference at 3- and 6-month follow up.

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.
60

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.
  • Phase 1

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.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Steps 2 Change (S2C)
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)
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.
Active Comparator: Control
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
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.

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
Retention
Time Frame: Up to 5 weeks
Treatment retention measured as the number of attended sessions (0-4; higher number is better)
Up to 5 weeks
Acceptability
Time Frame: After the first session, on the same calendar day
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
Time Frame: Up to 5 weeks
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 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
Pain Interference
Time Frame: 0-5 weeks
Pain interference measured using the average difference from baseline to post-treatment of two interference items on the PEG3: "What number best describes how pain is interfering with your life?" and "What number best describes how pain is interfering with your general activity?" (0-10; lower number is better)
0-5 weeks

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
Pain Interference
Time Frame: 3-month and 6-month follow up
Pain interference measured using the average difference from baseline to follow-up of two interference items on the PEG3: "What number best describes how pain is interfering with your life?" and "What number best describes how pain is interfering with your general activity?" (0-10; lower number is better)
3-month and 6-month follow up

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.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (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.
April 1, 2022

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.
February 28, 2025

Study Completion (Actual)

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.
September 30, 2025

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).
September 10, 2021

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.
September 10, 2021

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.
September 21, 2021

Study Record Updates

Last Update Posted (Actual)

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.
February 4, 2026

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.
February 2, 2026

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.
February 1, 2026

More Information

Terms related to this study

Keywords

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.
  • NURP-001-21S
  • IK2CX002286 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data that underlies published reported results after deidentification (text, tables, figures, appendices).

IPD Sharing Time Frame

9 months to 36 months after publication of primary findings.

IPD Sharing 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.

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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