NCT05688410Active, not recruitingNot Applicable
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
Case Western Reserve University2 sites in 1 country198 target enrollmentStarted: February 10, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 198
- Locations
- 2
- Primary Endpoint
- Drug cravings
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Drug cravings
Time Frame: 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 Outcomes
- Anxiety(Change from baseline to intervention program completion, an average of 8 weeks)
- Depression(Change from baseline to intervention program completion, an average of 8 weeks)
- Sleep(Change from baseline to intervention program completion, an average of 8 weeks)
- Drug Cravings using Questionnaire(Change from baseline to intervention program completion, an average of 8 weeks)
Investigators
Nora Nock
Associate Professor
Case Western Reserve University
Study Sites (2)
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