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Exercise + Psychotherapy for Opioid Use Disorder (EXPO-R33 Trial)

N/A
Recruiting
Led By Nora L. Nock, PhD
Research Sponsored by Case Western Reserve University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to intervention program completion, an average of 8 weeks
Awards & highlights

Summary

This trial will explore if "assisted" rate cycling, voluntary rate cycling and psychotherapy can help adults with opioid use disorder with cravings, depression, anxiety and sleep.

Who is the study for?
Adults aged 18-65 with an Opioid Use Disorder or Poly-substance Drug Use including opioids, enrolled in a residential drug treatment program. Participants must have chronic non-cancer pain and be medically cleared to exercise by the treatment center's staff.
What is being tested?
The trial is testing how 'assisted' rate cycling, voluntary rate cycling, and psychotherapy for pain (I-STOP) affect cravings in opioid users. It also looks at their impact on depression, anxiety, and sleep as secondary outcomes.
What are the potential side effects?
While specific side effects are not listed for this study, exercise may cause muscle soreness or injury if not done correctly. Psychotherapy generally has no direct physical side effects but can sometimes bring up uncomfortable emotions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to intervention program completion, an average of 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to intervention program completion, an average of 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug cravings
Secondary study objectives
Anxiety
Depression
Drug Cravings using Questionnaire
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Voluntary Exercise and No I-STOPExperimental Treatment1 Intervention
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).
Group II: Voluntary Exercise and I-STOPExperimental Treatment2 Interventions
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).
Group III: No Exercise and I-STOPExperimental Treatment1 Intervention
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).
Group IV: Assisted Exercise and No I-STOPExperimental Treatment1 Intervention
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).
Group V: Assisted Exercise and I-STOPExperimental Treatment2 Interventions
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).
Group VI: No Exercise and No I-STOPActive Control1 Intervention
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).

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
304 Previous Clinical Trials
246,853 Total Patients Enrolled
University of Colorado, DenverOTHER
1,786 Previous Clinical Trials
2,787,410 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
846 Previous Clinical Trials
672,727 Total Patients Enrolled

Media Library

Voluntary Exercise and No I-STOP Clinical Trial Eligibility Overview. Trial Name: NCT05688410 — N/A
Opioid Use Disorder Research Study Groups: Voluntary Exercise and No I-STOP, No Exercise and I-STOP, Assisted Exercise and I-STOP, Voluntary Exercise and I-STOP, Assisted Exercise and No I-STOP, No Exercise and No I-STOP
Opioid Use Disorder Clinical Trial 2023: Voluntary Exercise and No I-STOP Highlights & Side Effects. Trial Name: NCT05688410 — N/A
Voluntary Exercise and No I-STOP 2023 Treatment Timeline for Medical Study. Trial Name: NCT05688410 — N/A
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05688410 — N/A
~102 spots leftby May 2026
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