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NCT Number: NCT05688410

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado at Denver, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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))

Exclusion criteria

  • Any substantive contraindications to exercise
  • Psychiatrically unstable
  • Pregnant women
  • Non-English speaking adults
  • Adults unable to provide informed written consent

Treatment and study plan

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").

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".

Primary outcomes

  1. Drug cravings

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

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

Secondary outcomes

  1. Depression

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

    Change in depression: 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

  2. Anxiety

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

    Change in anxiety: 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 anxiety

  3. Sleep

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

    Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality

  4. Drug Cravings using Questionnaire

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

    standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Colorado, Denver

Registry information

Official study title

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

Acronym: EXPO-R33

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 18, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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