Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)

NCT05688410 | Active Not Recruiting DMC

• 2 other identifiers: STUDY20201427 - R33 Phase5R33AT010806-03
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

Brief Summary

This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.

Conditions

Opioid Use Disorder; Pain

Outcome Measures

Primary Outcomes (1)

• Drug cravings

  Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings;

  Change from baseline to intervention program completion, an average of 8 weeks

Secondary Outcomes (4)

• Depression

  Change from baseline to intervention program completion, an average of 8 weeks

• Anxiety

  Change from baseline to intervention program completion, an average of 8 weeks

• Sleep

  Change from baseline to intervention program completion, an average of 8 weeks

• Drug Cravings using Questionnaire

  Change from baseline to intervention program completion, an average of 8 weeks

Study Arms (6)

Assisted Exercise and I-STOP

EXPERIMENTAL

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).

Other: Exercise; Behavioral: Psychotherapy Pain and Addiction (I-STOP)

Voluntary Exercise and I-STOP

EXPERIMENTAL

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).

Other: Exercise; Behavioral: Psychotherapy Pain and Addiction (I-STOP)

Assisted Exercise and No I-STOP

EXPERIMENTAL

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).

Other: Exercise

Voluntary Exercise and No I-STOP

EXPERIMENTAL

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).

Other: Exercise

No Exercise and I-STOP

EXPERIMENTAL

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).

Behavioral: Psychotherapy Pain and Addiction (I-STOP)

No Exercise and No I-STOP

NO 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).

Interventions

Exercise OTHER

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").

Assisted Exercise and I-STOP; Assisted Exercise and No I-STOP; Voluntary Exercise and I-STOP; Voluntary Exercise and No I-STOP

Psychotherapy Pain and Addiction (I-STOP) BEHAVIORAL

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".

Assisted Exercise and I-STOP; No Exercise and I-STOP; Voluntary Exercise and I-STOP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old
• Must be enrolled in a residential/inpatient 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)
• Must have 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
• Psychiatrically unstable
• Pregnant women
• Non-English speaking adults
• Adults unable to provide informed written consent

Sponsors & Collaborators

• Case Western Reserve University: lead
• University of Colorado, Denver: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

University of Colorado at Denver

Denver, Colorado, 80217, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nora L. Nock, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

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

Model Details: 2\^1 x 3\^1 factorial randomized clinical trial

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 18, 2023
• Study Start: February 10, 2023
• Primary Completion (Estimated): July 5, 2028
• Study Completion (Estimated): July 5, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (2)