ACTIVE_NOT_RECRUITING

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

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Conditions

Opioid Use DisorderPain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-10
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05688410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 to 65 years old
  2. * Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center
  3. * 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)
  4. * Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
  5. * 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))
  1. * Any substantive contraindications to exercise
  2. * Psychiatrically unstable
  3. * Pregnant women
  4. * Non-English speaking adults
  5. * Adults unable to provide informed written consent

Contacts and Locations

Principal Investigator

Nora L. Nock, PhD
PRINCIPAL_INVESTIGATOR
Case Western Reserve University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Case Western Reserve University

  • Nora L. Nock, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2023-02-10
Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Pain