Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Opioid Use Disorders ("EXPO" Pilot Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Opioid Use Disorder
- Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: In the pilot trial (R61 Phase), the investigators will use a multi-phase optimization trial (MOST) approach to help identify which components of the exercise and psychotherapy for pain treatment program are viable and worth retaining in the planned fully powered trial (R33 Phase). In the R61 Phase/Pilot Trial, the investigators will have two intervention components: 1) exercise with 3 levels ('assisted', voluntary, none/treatment as usual (TAU); and, 2) psychotherapy for pain (I-STOP) with 2 levels (Yes/I-STOP, No/TAU). All participants will receive also receive the treatment as usual at their residential drug treatment program and any medication assisted treatment (MAT). This corresponds to a 2^1 x 3 1 full factorial with six experimental conditions.Masking: Double (Care Provider, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04736550
- Collaborators
- University of Colorado, Denver
- National Center for Complementary and Integrative Health (NCCIH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- Investigators
- Principal Investigator: Nora L Nock, PhD Case Western Reserve University
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