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

Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Psychotherapy for Pain (I-STOP)

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80217
      • University of Colorado at Denver
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assisted Exercise and 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.	Behavioral: Exercise; 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").; Behavioral: Psychotherapy for Pain (I-STOP); 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".
Experimental: Voluntary Exercise and 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.	Behavioral: Exercise; 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").; Behavioral: Psychotherapy for Pain (I-STOP); 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".
Experimental: No Exercise (TAU) and I-STOP; Participant will receive psychotherapy for pain (I-STOP). I-STOP will be offered 1 day/week.	Behavioral: Psychotherapy for Pain (I-STOP); 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".
Experimental: Assisted Exercise and No I-STOP (TAU); Participant will receive Assisted Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.	Behavioral: Exercise; 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").
Experimental: Voluntary Exercise and No I-STOP (TAU); Participant will receive Voluntary Rate Exercise (stationary cycling). Exercise (supervised) will be offered 3 days/week.	Behavioral: Exercise; 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").
No Intervention: No Exercise (TAU) and No I-STOP (TAU); Participant will receive their usual behavioral treatment offered at the residential drug treatment center and their medicated assisted treatment (MAT) as applicable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence (% of sessions attended)	Percentage of exercise and psychotherapy sessions attended	through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	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.	baseline/pre-intervention and immediately after the intervention
Change in weight	The investigators will evaluate potential changes in weight (lbs).	baseline/pre-intervention and immediately after the intervention
Change in depression	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.	baseline/pre-intervention and immediately after the intervention
The investigators will evaluate potential changes in drug cravings using self-report visual analog scale (VAS)	Higher scores indicate higher levels of cravings.	baseline/pre-intervention and immediately after the intervention
Change in cravings assessed by standardized questionnaire (Desires for Drug Questionnaire)	Higher scores indicate higher levels of cravings.	baseline/pre-intervention and immediately after the intervention
Change in sleep	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.	baseline/pre-intervention and immediately after the intervention
Change in Anxiety	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.	baseline/pre-intervention and immediately after the intervention

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: University of Colorado, Denver; National Institute of Neurological Disorders and Stroke (NINDS); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Nora L Nock, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; exercise; psychotherapy; OUD; residential drug treatment
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Opioid-Related Disorders; Chronic Pain; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavioral Disciplines and Activities; Exercise; Psychotherapy
• Other Study ID Numbers: STUDY20201427; 1R61AT010806 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No