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Exercise + Psychotherapy for Opioid Use Disorder and Pain

N/A
Waitlist Available
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 baseline/pre-intervention and immediately after the intervention
Awards & highlights

Summary

This trial will study if it is possible to help people with an opioid addiction and pain by combining exercise, cycling, and therapy specifically targeted at reducing pain.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include physical strain or injury from exercise activities. Psychological discomfort could arise during psychotherapy sessions aimed at managing pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/pre-intervention and immediately after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline/pre-intervention and immediately after the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence (% of sessions attended)
Secondary outcome measures
Change in Anxiety
Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)
Change in depression
+4 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER
1,758 Previous Clinical Trials
2,166,197 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
648,114 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
670,319 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04736550 — N/A
Opioid Use Disorder Research Study Groups: Voluntary Exercise and No I-STOP (TAU), Assisted Exercise and No I-STOP (TAU), No Exercise (TAU) and No I-STOP (TAU), No Exercise (TAU) and I-STOP, Assisted Exercise and I-STOP, Voluntary Exercise and I-STOP
Opioid Use Disorder Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04736550 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04736550 — N/A
~14 spots leftby Jul 2025