Your session is about to expire
← Back to Search
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
EXPO-R33 Trial 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.Check my eligibility
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.See study design
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.
EXPO-R33 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Drug cravings
Secondary outcome measures
Anxiety
Depression
Drug Cravings using Questionnaire
+1 moreEXPO-R33 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
299 Previous Clinical Trials
246,384 Total Patients Enrolled
University of Colorado, DenverOTHER
1,738 Previous Clinical Trials
2,149,328 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,775 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I am currently in a drug treatment program at a partner center.I experience chronic pain not related to cancer.You must be enrolled in a residential/inpatient drug rehabilitation program at an associated facility.You have been diagnosed with either an Opioid Use Disorder or Poly-substance Drug Use that includes opioids.You must receive authorization from the Medical Director, physician, clinical staff or PCP to participate in the study.I experience chronic pain not related to cancer.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Voluntary Exercise and No I-STOP
- Group 2: No Exercise and I-STOP
- Group 3: Assisted Exercise and I-STOP
- Group 4: Voluntary Exercise and I-STOP
- Group 5: Assisted Exercise and No I-STOP
- Group 6: No Exercise and No I-STOP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT05688410 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigational protocol account for individuals aged 75 and older?
"This trial requires applicants to fall between the ages of 18 and 65. On the other hand, there are 163 clinical trials that cater exclusively to those under 18 years old, as well as 639 studies suited for elderly patients over 65."
Answered by AI
Is this research project currently inviting participants?
"Affirmative. The information available on clinicaltrials.gov demonstrates that this medical trial is in the process of selecting participants, having first been advertised on January 23rd 2023 and revised most recently on January 17th of the same year. To fill their ranks, 198 individuals need to be recruited from two different centres."
Answered by AI
How many participants is this clinical trial enrolling?
"Affirmative. Per the clinicaltrials.gov repository, this medical trial is proactively recruiting participants for involvement in their research - which was first published on January 23rd 2023 and was recently updated on the 17th of that same month. There are 198 people required to take part at two separate sites."
Answered by AI
Could you elucidate the ideal candidate for this clinical trial?
"This trial seeks 198 participants aged 18 to 65 who are suffering from pain and satisfy the additional requirements. These include: enrolment in a residential/inpatient drug treatment facility, diagnosis of an Opioid Use Disorder or Poly-substance Drug Use with opioid component (per ICD-10), self reported chronic non-cancer related pains, and approval by medical staff at the participating center."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Colorado at Denver
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Ive tried PT and other pain medications but nothing gives last benefits. I have lower back pain that stemmed from a car accident I was involved with years ago. I was left with several herniated discs that cause discomfort/pain to this day.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger