Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders ("EXPO" Pilot Trial)
2 other identifiers
interventional
63
1 country
2
Brief Summary
The purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. The investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (I-STOP) in participants with an opioid use disorder (OUD) and pain enrolled in residential drug treatment programs. The investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and I-STOP on pain, cravings, depression, anxiety, weight and sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2021
CompletedFirst Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedMarch 24, 2026
March 1, 2026
1.6 years
January 27, 2021
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence (% of sessions attended)
Percentage of exercise and psychotherapy sessions attended
through study completion, an average of 8 weeks
Study Arms (6)
Assisted Exercise and I-STOP
EXPERIMENTALParticipant 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.
Voluntary Exercise and I-STOP
EXPERIMENTALParticipant 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.
No Exercise (TAU) and I-STOP
EXPERIMENTALParticipant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.
Assisted Exercise and No I-STOP (TAU)
EXPERIMENTALParticipant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.
Voluntary Exercise and No I-STOP (TAU)
EXPERIMENTALParticipant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.
No Exercise (TAU) and No I-STOP (TAU)
NO INTERVENTIONParticipant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.
Interventions
Participants who are randomized to exercise will be perform exercise on stationary bikes. Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. 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). I-STOP uses empirically validated pain psychotherapy approaches targeted to patients with an OUD using psycho-physiological self-regulation components and biofeedback with "Bio-dots".
Eligibility Criteria
You may qualify if:
- to 65 years old
- Must be enrolled in a Residential Drug Treatment Program at a collaborating drug treatment center
- Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx) and self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
- Must be approved to exercise in the study by the drug treatment center Medical Director, physician or other relevant clinical staff or primary care physician (PCP)
You may not qualify if:
- Any substantive contraindications to exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Colorado at Denver
Denver, Colorado, 80217, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nora L Nock, PhD
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 3, 2021
Study Start
January 8, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share