Active — Not RecruitingNot Applicable

Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)

United States198 participantsStarted 2023-02-10

Plain-language summary

This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Drug cravings

Timeframe: Change from baseline to intervention program completion, an average of 8 weeks

Trial details

NCT IDNCT05688410

SponsorCase Western Reserve University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-05

View on ClinicalTrials.gov More Opioid Use Disorder trials