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The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated November 7, 2023 (before its estimated August 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Aug 31, 2023 to Aug 31, 2024v7
  2. 2 versions Re-verified since Mar 29, 2022, no change to tracked fieldsv5-v6
  3. Eligibility criteria expanded, about 28 words
    • Study description expanded, about 141 words
    • Collaborators expanded, about 8 words
    v4
  4. Start date changed from estimate of Nov 2019 to Nov 8, 2019v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2019 to Nov 2019
    • Site details revised
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 project tests the efficacy of glutamate modulators in non-depressed individuals with alcohol use disorder (AUD); the primary hypothesis is that the glutamate modulator being tested reduces heavy drinking days compared to the active control. It also aims to investigate, using a 2 by 2 factorial (2x2) design, the hypothesis that the effects of the glutamate modulator are enhanced when combined with behavioral treatment.
Trial Details
NCT Number NCT04084860
Lead Sponsor New York State Psychiatric Institute
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Use Disorder
Related terms Alcoholism
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov