Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Adherence (% of sessions attended)
Study Overview
Brief Summary
The purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. The investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (I-STOP) in participants with an opioid use disorder (OUD) and pain enrolled in residential drug treatment programs. The investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and I-STOP on pain, cravings, depression, anxiety, weight 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 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) and 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
Outcomes
Primary Outcomes
Adherence (% of sessions attended)
Time Frame: through study completion, an average of 8 weeks
Percentage of exercise and psychotherapy sessions attended
Secondary Outcomes
- Change in weight(baseline/pre-intervention and immediately after the intervention)
- The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)(baseline/pre-intervention and immediately after the intervention)
- Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)(baseline/pre-intervention and immediately after the intervention)
- Change in pain(baseline/pre-intervention and immediately after the intervention)
- Change in depression(baseline/pre-intervention and immediately after the intervention)
- Change in sleep(baseline/pre-intervention and immediately after the intervention)
- Change in Anxiety(baseline/pre-intervention and immediately after the intervention)
Investigators
Nora Nock
Associate Professor
Case Western Reserve University