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Adaptive Walking Intervention for Chronic Pain in Opioid Use Disorder

Phase 1

Recruiting

Led By R. Ross MacLean, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported ability to walk 1 block

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month and 6-month follow up

Awards & highlights

Study Summary

This trial will study whether a behaviorally focused pain treatment, which includes pain education and a pedometer assisted adaptive walking program, is feasible and acceptable for Veterans receiving treatment for opioid use disorder.

Who is the study for?

This trial is for Veterans with chronic pain and opioid use disorder (OUD) who are currently on a stable dose of opioid agonist treatment. Participants must be able to walk, have access to a mobile phone with data, and experience pain that limits activity or enjoyment. Those with untreated major psychiatric disorders, planned surgeries for pain, active suicidal thoughts, or current CBT for pain cannot join.Check my eligibility

What is being tested?

The study tests a non-drug intervention called Steps 2 Change (S2C), which includes education about managing pain and an adaptive walking program using pedometers. The goal is to see if this can help manage chronic pain in Veterans receiving treatment for OUD without relying on more opioids.See study design

What are the potential side effects?

Since the intervention involves behavioral changes rather than medication, side effects may include muscle soreness or fatigue from increased physical activity. However, no drug-related side effects are expected as it's not testing new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk at least one block by myself.

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I experience daily pain that limits my activities or enjoyment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-month and 6-month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-month and 6-month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-month and 6-month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability

Fidelity

Retention

Other outcome measures

Pain

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Steps 2 Change (S2C)Experimental Treatment1 Intervention

Participants randomized to S2C will be scheduled for 60-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 starting after Session 1. 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 flare ups caused by 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.

Group II: ControlActive Control1 Intervention

Participants randomized to control will be scheduled for 60-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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,124 Total Patients Enrolled

R. Ross MacLean, PhDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT

Media Library

Steps 2 Change (S2C) Clinical Trial Eligibility Overview. Trial Name: NCT05051644 — Phase 1

Opioid Use Disorder Research Study Groups: Steps 2 Change (S2C), Control

Opioid Use Disorder Clinical Trial 2023: Steps 2 Change (S2C) Highlights & Side Effects. Trial Name: NCT05051644 — Phase 1

Steps 2 Change (S2C) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05051644 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can the S2C protocol provide a secure environment for individuals under treatment?

"The safety rating of Steps 2 Change (S2C) is deemed to be a 1, due to limited research and data supporting both its efficacy and safety, as this study is in the first phase."

Answered by AI

How many participants are being monitored for this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, the trial which was posted on April 1st 2022 is actively recruiting participants. There are 60 patients that need to be enrolled in this study from a single site."

Answered by AI

Are there any available slots open for prospective participants in the trial?

"Affirmative. The information available on clinicaltrials.gov attests that this medical trial is currently seeking participants, with the initial listing posted April 1st 2022 and most recently updated April 5th 2022. Sixty individuals are needed to be enrolled from a lone location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05051644.

All > Chronic Pain > Probuphine