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

N/AActive Not RecruitingNCT05688410

Case Western Reserve University198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

198

Conditions

Opioid Use Disorder Pain

Interventions

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".

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado at Denver

Denver, Colorado, United States

Case Western Reserve University

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Drug cravings

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