Exercise + Psychotherapy for Opioid Use Disorder and Pain

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byNora L Nock, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Case Western Reserve University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-65 with opioid use disorder and pain, who are currently in a residential drug treatment program. Participants must have approval to exercise from medical staff and be diagnosed with OUD or poly-substance use that includes opioids.

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

+1 more

Participant Groups

The EXPO pilot trial is testing the integration of 'assisted' rate cycling, voluntary rate cycling, and specialized psychotherapy (I-STOP) into drug treatment programs to see if they help manage pain, cravings, depression, anxiety, weight issues, and sleep problems in people with opioid addiction.

6Treatment groups

Experimental Treatment

Active Control

Group I: Voluntary Exercise and No I-STOP (TAU)Experimental Treatment1 Intervention

Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Group II: Voluntary Exercise and I-STOPExperimental Treatment2 Interventions

Participant will receive Voluntary Rate Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week.

Group III: No Exercise (TAU) and I-STOPExperimental Treatment1 Intervention

Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.

Group IV: Assisted Exercise and No I-STOP (TAU)Experimental Treatment1 Intervention

Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Group V: Assisted Exercise and I-STOPExperimental Treatment2 Interventions

Participant will receive Assisted Exercise (stationary cycling) and psychotherapy for pain (I-STOP). Exercise (supervised) will be offered 3 days/week. I-STOP will be offered 1 day/week.

Group VI: No Exercise (TAU) and No I-STOP (TAU)Active Control1 Intervention

Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.