NCT05492825 IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment Programs
| NCT ID | NCT05492825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Einstein College of Medicine |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2026-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-02-27 with a primary completion date of 2026-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. age ≥18 years old 2. English or Spanish proficiency (i.e., be able to participate in study interventions and interviews in English or Spanish) 3. receiving methadone or buprenorphine treatment for OUD in the Montefiore OTP network for at least 12 weeks, with no dose change in 14 days 4. Chronic low or mid back pain, with at least moderate pain severity (score of ≥4 on the Pain, Enjoyment of Life and General Activity (PEG) Scale) 5. Willingness to participate in all study components 6. ability to provide informed consent, assessed using consent teach-back Exclusion Criteria: 1. severe disabling conditions that could make participation in yoga or PT hazardous (e.g., spinal canal stenosis; severe scoliosis; vertebral fracture, history of spine surgery, or joint surgery in the past six months; severe or progressive neurological deficits, or cardiovascular or neurological disease requiring hospitalization in the past six months; unable to stand for at least 60 seconds; regular use of a wheelchair or motorized scooter, or regular use of a walker and inability to walk at least 4 steps without it; 3 or more falls in the prior year with at least one being non-mechanical;; or other severe disabling conditions deemed by the study clinician or MPI to preclude safe or adequate participation in the study) 2. acute exacerbation of psychiatric conditions that preclude the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis) 3. cancer pain related to malignancy 4. yoga practice or PT in the prior 60 days
Contact & Investigator
Joanna Starrels, MD
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine
Frequently Asked Questions
Who can join the NCT05492825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Substance Use Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05492825 currently recruiting?
Yes, NCT05492825 is actively recruiting participants. Contact the research team at SNAHVI@montefiore.org for enrollment information.
Where is the NCT05492825 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05492825 clinical trial?
NCT05492825 is sponsored by Albert Einstein College of Medicine. The principal investigator is Joanna Starrels, MD at Albert Einstein College of Medicine. The trial plans to enroll 180 participants.