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Optimization of NIBS for Treatment of Addiction

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site contacts updated at 1 of 3 sitesv9
  2. Eligibility criteria shortened, about 75 words
    • Site contacts updated at 1 of 3 sites
    v8
  3. Study sites: 2 to 3v7
  4. Primary and study completion dates: Oct 31, 2025 to Oct 31, 2027v6
  5. Enrollment target: 30 to 126
    • Start date: Jul 18, 2020 to Apr 4, 2021
    • Primary and study completion dates: Aug 2026 to Oct 31, 2025
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: Aug 2024 to Aug 2026v4
  2. Primary completion date: Aug 2022 to Aug 2024
    • Enrollment target: 26 to 30
    • Study completion date: Aug 2023 to Aug 2024
    • Site contacts updated at 1 of 2 sites
    v3
  3. Enrollment target: 58 to 26v2 Show 5 more changesShow less
    • Primary completion date: Jan 2022 to Aug 2022
    • Start date: Feb 18, 2020 to Jul 18, 2020
    • Study sites: 1 to 2
    • Study completion date: Jan 2022 to Aug 2023
    • Eligibility criteria shortened, about 34 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators hypothesize that there will be a decrease in drug use and improved psychosocial assessments with active stimulation, when compared to sham stimulation.
Trial Details
NCT Number NCT04379115
Lead Sponsor Case Western Reserve University
Collaborators: Highland Instruments, Inc.
Conditions
(from sponsor)		 Opioid-use Disorder, Chronic Pain
Related terms Chronic Pain, Opioid-Related Disorders
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov