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Deep Brain Stimulation Effects In Patients With Opioid Use Disorder

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 43 wordsv15
  2. Re-verified, no change to tracked fieldsv14
  3. Primary completion date: Dec 2025 to Jan 2029
    • Study completion date: Dec 2026 to Jan 2030
    • Eligibility criteria expanded, about 20 words
    v13
  4. Primary completion date: Feb 2025 to Dec 2025
    • Study completion date: Feb 2025 to Dec 2026
    • Site contact updated
    v12
  5. Eligibility criteria shortened, about 104 words
    • Site contact updated
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary and study completion dates: Feb 2023 to Feb 2025v10
  2. Trial status: Not Yet Recruiting to Recruitingv9 Show 4 more changesShow less
    • Primary completion date: Jan 2023 to Feb 2023
    • Start date changed from estimate of Mar 1, 2022 to Feb 7, 2022
    • Eligibility criteria expanded, about 6 words
    • Site details revised
  3. Start date: Oct 2021 to Mar 1, 2022v8
  4. Start date: May 2021 to Oct 2021
    • Study description shortened, about 14 words
    • Study site revised
    v7
  5. Start date: Jan 2021 to May 2021v6
  6. Start date: Nov 2020 to Jan 2021
    • Primary completion date: Nov 2022 to Jan 2023
    • Study completion date: Dec 2022 to Feb 2023
    v5
  7. Start date: Sep 2020 to Nov 2020
    • Primary completion date: Sep 2022 to Nov 2022
    • Study completion date: Oct 2022 to Dec 2022
    v4
  8. Start date: Jul 2020 to Sep 2020v3
  9. Primary completion date: Jul 2022 to Sep 2022
    • Study completion date: Jul 2022 to Oct 2022
    • Start date: Jun 2020 to Jul 2020
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot study to evaluate the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAc) as adjunctive treatment for treatment-refractory opioid use disorder. This study will include 3 individuals with opioid use disorder and relapsing opioid use despite active participation in a drug addiction treatment program.
Trial Details
NCT Number NCT04354077
Lead Sponsor Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborators: Abbott
Conditions
(from sponsor)		 Opioid-use Disorder
Related terms Behavior, Addictive, Opioid-Related Disorders
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov