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IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Site details revised
    • Collaborators: 3 to 5
    v11
  2. Re-verified, no change to tracked fieldsv10
  3. Primary and study completion dates: Nov 2026 to Nov 2, 2026v9
  4. Enrollment target: 345 to 180v8 Show 5 more changesShow less
    • Primary endpoints: 3 to 2
    • Primary and study completion dates: Apr 2027 to Nov 2026
    • Eligibility criteria expanded, about 109 words
    • Secondary endpoints: 4 to 20
    • Collaborators: 1 to 3
  5. Primary and study completion dates: Feb 2027 to Apr 2027v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Nov 8, 2026 to Feb 2027
    • Study completion date: Feb 6, 2027 to Feb 2027
    v5
  3. Primary completion date: Mar 15, 2026 to Nov 8, 2026
    • Start date: Jan 25, 2023 to Feb 27, 2023
    • Study completion date: Mar 15, 2027 to Feb 6, 2027
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2023 to Jan 25, 2023
    • Site details revised
    v3
  5. Start date: Sep 1, 2022 to Jan 15, 2023
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 10 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.
Trial Details
NCT Number NCT05492825
Lead Sponsor Albert Einstein College of Medicine
Collaborators: National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, Wake Forest University, Tulane University, Southern California University of Health Sciences
Conditions
(from sponsor)		 Substance Use Disorders, Chronic Pain, Opioid Use Disorder, Back Pain Lower Back Chronic
Related terms Chronic Pain, Opioid-Related Disorders, Substance-Related Disorders
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov