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

Case Western Reserve University2 sites in 1 country198 target enrollmentFebruary 10, 2023

ConditionsOpioid Use Disorder Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Opioid Use Disorder
Sponsor: Case Western Reserve University
Enrollment: 198
Locations: 2
Primary Endpoint: Drug cravings
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 10, 2023

End Date

July 5, 2028

Last Updated

last month

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Case Western Reserve University

Responsible Party

Principal Investigator

Nora Nock

Associate Professor

Case Western Reserve University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Anxiety(Change from baseline to intervention program completion, an average of 8 weeks)
Depression(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)