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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to intervention program completion, an average of 8 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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