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

Not Applicable

Recruiting

• Conditions: Pain; Opioid Use Disorder

• Registration Number: NCT05688410
• Lead Sponsor: Case Western Reserve University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-18
• Study Start: 2023-02-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Drug cravings	Change from baseline to intervention program completion, an average of 8 weeks	Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings;

Secondary Outcome Measures

Name	Time	Method
Anxiety	Change from baseline to intervention program completion, an average of 8 weeks	Change in anxiety: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; Higher scores indicate higher levels of anxiety
Depression	Change from baseline to intervention program completion, an average of 8 weeks	Change in depression: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; higher scores indicate higher levels of depression
Sleep	Change from baseline to intervention program completion, an average of 8 weeks	Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality
Drug Cravings using Questionnaire	Change from baseline to intervention program completion, an average of 8 weeks	standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings

Trial Locations

Locations (2)

University of Colorado at Denver; 🇺🇸 Denver, Colorado, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States