NCT05688410: EXPO-R33

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

Active, enrolled NA Last updated 24 March 2026

What this trial tests

NA trial testing Exercise in Opioid Use Disorder in 198 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 February 2023

Primary endpoint
5 July 2028

5 July 2028

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	198
Start date	10 February 2023
Primary completion	5 July 2028
Estimated completion	5 July 2028
Sites	2 locations across United States

Drugs / interventions tested

• Exercise
• Psychotherapy Pain and Addiction (I-STOP)

Conditions studied

• Opioid Use Disorder — all drugs for Opioid Use Disorder →
• Pain — all drugs for Pain →

Sponsor

Case Western Reserve University

Who can join

Adults 18 to 65, any sex, with Opioid Use Disorder or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.