Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)
- Conditions
- PainOpioid Use Disorder
- Interventions
- Other: ExerciseBehavioral: Psychotherapy Pain and Addiction (I-STOP)
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 198
- 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))
- 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
- Arm && Interventions
Group Intervention Description Assisted Exercise and I-STOP Psychotherapy Pain and Addiction (I-STOP) Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). Voluntary Exercise and I-STOP Exercise Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). Voluntary Exercise and I-STOP Psychotherapy Pain and Addiction (I-STOP) Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). Voluntary Exercise and No I-STOP Exercise Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). No Exercise and I-STOP Psychotherapy Pain and Addiction (I-STOP) Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). Assisted Exercise and I-STOP Exercise Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). Assisted Exercise and No I-STOP Exercise Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).
- 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 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
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
Trial Locations
- Locations (2)
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Colorado at Denver
🇺🇸Denver, Colorado, United States