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Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 127 to confirmed 125
    • Primary and study completion dates: Apr 27, 2027 to Apr 29, 2027
    • Site details revised
    v18
  2. Enrollment target: 123 to 127
    • Collaborators: 1 to 6
    • Publications: 1 to 56
    v17
  3. Primary endpoints revised (2)v16 Show 6 more changesShow less
    • Enrollment target: 160 to 123
    • Primary and study completion dates: Apr 2027 to Apr 27, 2027
    • Eligibility criteria revised
    • Secondary endpoints: 19 to 22
    • Study description expanded, about 6 words
    • Site contact updated
  4. Primary and study completion dates: Oct 2027 to Apr 2027
    • Site contact updated
    v15
  5. Enrollment target: 280 to 160
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 18 to 19
    • Study arms: 4 to 3
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Jul 2027 to Oct 2027
    • Eligibility criteria revised
    • Study site revised
    • Collaborators expanded, about 6 words
    v13
  2. Primary completion date: Dec 15, 2025 to Jul 2027
    • Study completion date: Aug 31, 2026 to Oct 2027
    • Start date: Feb 1, 2023 to Feb 2, 2023
    v12
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2023 to Feb 1, 2023
    • Site details revised
    v11
  4. Start date: Nov 1, 2022 to Jan 1, 2023v10
  5. Start date: Aug 31, 2022 to Nov 1, 2022v9
  6. Start date: Aug 1, 2022 to Aug 31, 2022
    • Site contact updated
    v8
  7. Site contact updatedv7
  8. Start date: Apr 1, 2022 to Aug 1, 2022
    • Study sites: 0 to 1
    • Secondary endpoints: 19 to 18
    • Study title expanded, about 7 words
    v6
  9. Start date: Dec 1, 2021 to Apr 1, 2022v5
  10. Start date: Nov 1, 2021 to Dec 1, 2021v4
  11. Re-verified, no change to tracked fieldsv3
  12. Start date: Sep 1, 2021 to Nov 1, 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The proposed IMPOWR Research Center at Montefiore-Einstein (IMPOWR-ME) will create a multidisciplinary and synergistic program of research to test multimodal treatments that address both chronic pain and opioid use disorder. IMPOWR-ME will generate critical knowledge about the effectiveness, implementation, and cost effectiveness of providing Acceptance and Commitment Therapy and/or a care management smartphone app for individuals in primary care-based buprenorphine treatment. Patients with lived experience with chronic pain and/or opioid use disorder, patient and policy advocates, payors, and health system partners will be engaged in all stages of the research. IMPOWR-ME is well-positioned to become a long-lasting hub for stakeholder-engaged research with multidisciplinary senior and early stage investigators focused on reducing overdose through better treatments for OUD and CP.
Trial Details
NCT Number NCT05039554
Lead Sponsor Albert Einstein College of Medicine
Collaborators: National Institute on Drug Abuse (NIDA), Weill Medical College of Cornell University, Wake Forest University Health Sciences, University of Miami, Valera Health, Tulane University
Conditions
(from sponsor)		 Opioid-use Disorder, Chronic Pain
Related terms Chronic Pain, Opioid-Related Disorders
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov