Opioid Use DisorderPhase 1NCT05051644
An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
A Phase 1 study testing Steps 2 Change (S2C) in people with Opioid Use Disorder and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Chronic Pain
- What is being tested?
- Steps 2 Change (S2C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 30 Sep 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
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.
Read the 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.
- Conditions
- Opioid Use Disorder, Chronic Pain
- Being tested
- Steps 2 Change (S2C), Control
- Keywords
- Chronic Pain, Opioid Use Disorder, opioid agonist treatment, medications for opioid use disorder, methadone, buprenorphine, walking, exercise
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steps 2 Change (S2C)Behavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Treatment retention measured as the number of attended sessions (0-4; higher number is better)
Measured: 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).
Measured: 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).
Measured: Up to 5 weeks
Secondary outcomes (1)
Pain Interference
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)
Measured: 0-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Apr 2022
- Primary completion28 Feb 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- R. Ross MacLean, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051644
- Sponsor's protocol ID
- NURP-001-21S
- Other IDs
- IK2CX002286
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2021
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data that underlies published reported results after deidentification (text, tables, figures, appendices).
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
- ClinicalTrials.gov ID
- NCT05051644
- Acronym / sponsor ID
- NURP-001-21S
- Conditions
- Opioid Use Disorder, Chronic Pain
- Keywords
- Chronic Pain, Opioid Use Disorder, opioid agonist treatment, medications for opioid use disorder, methadone, buprenorphine, walking, exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Steps 2 Change (S2C) | Experimental | Behavioral: 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. |
| Control | Active comparator | Behavioral: ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Steps 2 Change (S2C) |
| ControlThe 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. | Behavioural | Control |
Primary outcome
Retention
Time frame: Up to 5 weeks
Treatment retention measured as the number of attended sessions (0-4; higher number is better)
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).
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).
1 secondary outcome
Pain Interference
Time frame: 0-5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data that underlies published reported results after deidentification (text, tables, figures, appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Ross MacLean, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Steps 2 Change (S2C) in people with Opioid Use Disorder and Chronic Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: Up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.