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Exercise + Psychotherapy for Opioid Use Disorder and Pain

N/A

Waitlist Available

Led By Nora L Nock, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline/pre-intervention and immediately after the intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if it is possible to help people with an opioid addiction and pain by combining exercise, cycling, and therapy specifically targeted at reducing pain.

Who is the study for?

This trial is for adults aged 18-65 with opioid use disorder and pain, who are currently in a residential drug treatment program. Participants must have approval to exercise from medical staff and be diagnosed with OUD or poly-substance use that includes opioids.

What is being tested?

The EXPO pilot trial is testing the integration of 'assisted' rate cycling, voluntary rate cycling, and specialized psychotherapy (I-STOP) into drug treatment programs to see if they help manage pain, cravings, depression, anxiety, weight issues, and sleep problems in people with opioid addiction.

What are the potential side effects?

Potential side effects may include physical strain or injury from exercise activities. Psychological discomfort could arise during psychotherapy sessions aimed at managing pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline/pre-intervention and immediately after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline/pre-intervention and immediately after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/pre-intervention and immediately after the intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adherence (% of sessions attended)

Secondary study objectives

Change in Anxiety

Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)

Change in depression

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Voluntary Exercise and No I-STOP (TAU)Experimental Treatment1 Intervention

Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Group II: Voluntary Exercise and I-STOPExperimental Treatment2 Interventions

Participant will receive Voluntary Rate Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week.

Group III: No Exercise (TAU) and I-STOPExperimental Treatment1 Intervention

Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.

Group IV: Assisted Exercise and No I-STOP (TAU)Experimental Treatment1 Intervention

Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Group V: Assisted Exercise and I-STOPExperimental Treatment2 Interventions

Participant will receive Assisted Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week.

Group VI: No Exercise (TAU) and No I-STOP (TAU)Active Control1 Intervention

Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~820

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