Combining exercise and therapy to help adults with opioid addiction and pain
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
This study is testing whether combining exercise with therapy can help adults struggling with opioid addiction and pain feel better and manage their cravings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Case Western Reserve University Academic / other |
| Locations | 2 sites (Denver, Colorado and 1 other locations) |
| Trial ID | NCT05688410 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of assisted and voluntary rate cycling exercises, along with psychotherapy, as treatments for cravings in adults with opioid use disorder. Participants will be randomly assigned to receive these interventions individually or in combination, while also assessing their impact on secondary outcomes such as depression, anxiety, and sleep quality. The study aims to provide a comprehensive approach to managing both addiction and chronic pain in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are enrolled in a residential drug treatment program and have a diagnosis of opioid use disorder along with self-reported chronic pain.
Not a fit: Patients who are psychiatrically unstable, pregnant, or have contraindications to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cravings and improve overall well-being for patients struggling with opioid use disorder and chronic pain.
How similar studies have performed: While the combination of exercise and psychotherapy is a promising approach, this specific trial's methodology is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 65 years old * Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center * Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx) * Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder * Must be approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP)) Exclusion Criteria: * Any substantive contraindications to exercise * Psychiatrically unstable * Pregnant women * Non-English speaking adults * Adults unable to provide informed written consent
Where this trial is running
Denver, Colorado and 1 other locations
- University of Colorado at Denver — Denver, Colorado, United States (Not_yet_recruiting)
- Case Western Reserve University — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Nora L. Nock, PhD — Case Western Reserve University
- Study coordinator: Nora L. Nock, PhD
- Email: nln@case.edu
- Phone: 216-368-5653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.