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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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))

Locations
United States
Colorado
University of Colorado at Denver
NOT_YET_RECRUITING
Denver
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Contact Information
Primary
Nora L. Nock, PhD
nln@case.edu
216-368-5653
Time Frame
Start Date: 2023-02-10
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 198
Treatments
Experimental: Assisted Exercise and 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).
Experimental: Voluntary Exercise and 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).
Experimental: Assisted Exercise and No 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 randomized to No I-STOP will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU).
Experimental: Voluntary Exercise and No I-STOP
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).
Experimental: No Exercise and 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).
No_intervention: No Exercise and No 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).
Related Therapeutic Areas
Opioid Use Disorder
Sponsors
Collaborators: National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Case Western Reserve University

This content was sourced from clinicaltrials.gov

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