What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist that reduces withdrawal symptoms and cravings. Buprenorphine, a partial opioid agonist, is available in various formulations such as sublingual tablets and buccal films, and it helps to alleviate withdrawal symptoms and reduce cravings with a lower risk of misuse. Naltrexone, an opioid antagonist, blocks the effects of opioids and is available in oral and extended-release injectable forms. These pharmacologic treatments are often complemented by non-pharmacologic interventions, such as the behaviorally focused pain treatment involving pain education and pedometer-assisted adaptive walking programs, to enhance overall treatment outcomes.

What other types of research exist?

Promising, novel alternatives to behaviorally focused pain treatment for OUD patients include: 1) Multidisciplinary biopsychosocial rehabilitation, which integrates physical therapy, psychological support, and social interventions to address chronic pain comprehensively. 2) Mind-body programs, such as mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT), which have shown effectiveness in managing chronic pain and reducing opioid use. 3) Exercise therapy tailored to individual needs, including supervised exercise programs and motivational enhancement therapy to improve adherence and outcomes. 4) Opioid rotation strategies, particularly switching to buprenorphine or methadone, which can provide better pain control and reduce opioid misuse risks.

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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

Must not have

Currently engaged in CBT for chronic pain treatment

Planned surgical intervention for pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-month and 6-month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a walking program with pain education for Veterans with chronic pain and opioid use disorder. The goal is to help manage their pain by teaching them about it and encouraging more physical activity. Participants will use pedometers to track their steps and attend regular sessions. Pedometer-driven walking programs have been previously studied for their feasibility and effectiveness in managing chronic pain and increasing physical activity.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing cognitive behavioral therapy for chronic pain.

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I am scheduled for surgery to manage my pain.

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I have had thoughts of harming myself in the past month.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Fidelity

Retention

Other study objectives

Pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Opioid Use Disorder (OUD) include opioid agonist treatments (OAT) such as methadone and buprenorphine, which work by binding to the same opioid receptors in the brain as other opioids, reducing cravings and withdrawal symptoms without producing the same high. Naltrexone, an opioid antagonist, blocks these receptors to prevent the effects of opioids. These treatments are crucial for managing OUD as they help stabilize patients, allowing them to engage in additional therapies. The behaviorally focused pain treatment being studied, which includes pain education and a pedometer-assisted adaptive walking program, complements OAT by addressing chronic pain through non-pharmacologic means, potentially reducing the need for higher opioid doses and improving overall quality of life for veterans with OUD.