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

Not Applicable

Active, not recruiting

• Conditions: Opioid-use Disorder; Pain
• Interventions: Behavioral: Exercise; Behavioral: Psychotherapy for Pain (I-STOP)

• Registration Number: NCT04736550
• Lead Sponsor: Case Western Reserve University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-03
• Primary Completion: 2022-08-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 18 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)

Exclusion Criteria

• Any substantive contraindications to exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Assisted Exercise and I-STOP	Psychotherapy for Pain (I-STOP)	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.
Voluntary Exercise and I-STOP	Exercise	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.
Assisted Exercise and I-STOP	Exercise	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.
Voluntary Exercise and No I-STOP (TAU)	Exercise	Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.
No Exercise (TAU) and I-STOP	Psychotherapy for Pain (I-STOP)	Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.
Voluntary Exercise and I-STOP	Psychotherapy for Pain (I-STOP)	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.
Assisted Exercise and No I-STOP (TAU)	Exercise	Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.

Primary Outcome Measures

Name	Time	Method
Adherence (% of sessions attended)	through study completion, an average of 8 weeks	Percentage of exercise and psychotherapy sessions attended

Secondary Outcome Measures

Name	Time	Method
Change in weight	baseline/pre-intervention and immediately after the intervention	The investigators will evaluate potential changes in weight (lbs).
The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)	baseline/pre-intervention and immediately after the intervention	Higher scores indicate higher levels of cravings.
Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)	baseline/pre-intervention and immediately after the intervention	Higher scores indicate higher levels of cravings.
Change in pain	baseline/pre-intervention and immediately after the intervention	The investigators will evaluate potential changes in pain using a cold pressor pain task. Pain sensitivity is the time spent in a cold water bath until the first report of pain and pain tolerance is the total time in the cold water bath.
Change in depression	baseline/pre-intervention and immediately after the intervention	The investigators will evaluate potential changes in depression using self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS). Total Score range: 0-21; Higher scores indicate higher levels of depression.
Change in sleep	baseline/pre-intervention and immediately after the intervention	The investigators will evaluate potential changes in sleep using self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI). Total Score range: 0-21; Higher scores indicate poorer sleep quality.
Change in Anxiety	baseline/pre-intervention and immediately after the intervention	The investigators will evaluate potential changes in depression using self-report, standardized questionnaire (Anxiety sub-scale in Hospital Anxiety and Depression Scale, HADS). Total Score range: 0-21; Higher scores indicate higher levels of anxiety.

Trial Locations

Locations (2)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

University of Colorado at Denver; 🇺🇸 Denver, Colorado, United States