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Intranasal Insulin for Treatment of Alcohol Use Disorder

Study acronym: ITA
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Eligibility criteria expanded, about 18 words
    • Publications: details revised at 1 of 1 entry
  2. Start date: Feb 25, 2024 to Feb 25, 2025v6
  3. Primary completion date: Mar 25, 2025 to Dec 31, 2026
    • Study completion date: Mar 30, 2025 to Jan 31, 2027
    • Start date: Mar 25, 2024 to Feb 25, 2024
    • Site contact updated
    v5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jan 20, 2025 to Mar 25, 2025
    • Study completion date: Jan 30, 2025 to Mar 30, 2025
    • Start date changed from estimate of Apr 15, 2024 to Mar 25, 2024
  5. Start date: Jan 21, 2024 to Apr 15, 2024v3
  6. Start date: Sep 21, 2023 to Jan 21, 2024
    • Primary completion date: Sep 20, 2024 to Jan 20, 2025
    • Study completion date: Sep 30, 2024 to Jan 30, 2025
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.
Trial Details
NCT Number NCT05988632
Lead Sponsor Brown University
Conditions
(from sponsor)		 Alcohol Use Disorder
Related terms Alcoholism
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov