Clinical trial NCT05688410: Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)
Official title: Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Pain
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-01-18
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2\^1 x 3\^1 factorial randomized clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Drug cravings
timeFrame: Change from baseline to intervention program completion, an average of 8 weeks
Secondary outcomes:
measure: Depression
timeFrame: Change from baseline to intervention program completion, an average of 8 weeks
measure: Anxiety
timeFrame: Change from baseline to intervention program completion, an average of 8 weeks
measure: Sleep
timeFrame: Change from baseline to intervention program completion, an average of 8 weeks
measure: Drug Cravings using Questionnaire
timeFrame: Change from baseline to intervention program completion, an average of 8 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado at Denver
state: Colorado
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Nora L. Nock, PhD
role: PRINCIPAL_INVESTIGATOR
References: