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

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

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

NCT05688410•Case Western Reserve University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

University of Colorado at Denver

Denver, Colorado, United States

Case Western Reserve University

Cleveland, Ohio, United States

Key Dates

Start Date

February 10, 2023

Primary Completion Date

November 30, 2025

Completion Date

November 30, 2026

Last Updated

December 26, 2025

Enrollment

198

ESTIMATED participants

Conditions

Opioid Use DisorderPain

Interventions

Exercise

OTHER

Psychotherapy Pain and Addiction (I-STOP)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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