← Back to Search

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline/pre-intervention and immediately after the intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverOTHER

1,732 Previous Clinical Trials

2,143,520 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,243 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

831 Previous Clinical Trials

668,870 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for prospective participants in this experiment?

"As per the information found on clinicaltrials.gov, this research project is actively looking for participants and has been since February 8th 2021. The trial was last modified on September 19th 2022."

Answered by AI

Is eligibility for this investigation open to those under 45 years of age?

"This clinical trial is available to individuals aged 18-65. There are 161 trials for minors and 644 studies dedicated to elderly patients."

Answered by AI

Am I qualified to be a participant in this medical experiment?

"To be admitted to the trial, prospective participants must suffer from pain and meet the age criteria of 18-65 years old. Currently, there is a need for 60 individuals to join this study."

Answered by AI

How many participants are taking part in the research project?

"Correct. Clinicaltrials.gov confirms that this clinical trial, which was first advertised in February 2021, is actively seeking participants. Sixty study volunteers must be recruited from two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders ("EXPO" Pilot Trial)

Nora Nock 2021. "Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders ("EXPO" Pilot Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04736550.

All > Opioid Dependence > Addiction