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HA35 Acute Alcohol Study

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 1, 2026 → Oct 1, 2028
See other at-risk trials from The Cleveland Clinic

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 1, 2026 to Oct 1, 2028
    • Study completion pushed from Oct 1, 2027 to Oct 1, 2028
    • Eligibility criteria expanded, about 15 words
  2. Primary completion date: Oct 1, 2025 to Oct 1, 2026
    • Study completion date: Oct 1, 2026 to Oct 1, 2027
    v10
  3. 2 versions Re-verified since Oct 10, 2024, no change to tracked fieldsv8-v9
  4. Primary completion date: Oct 1, 2023 to Oct 1, 2025
    • Study completion date: Oct 1, 2024 to Oct 1, 2026
    v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 1, 2022 to Feb 1, 2022
    v5
  2. Start date: Dec 1, 2021 to Mar 1, 2022v4
  3. Start date: Oct 1, 2021 to Dec 1, 2021v3
  4. Primary endpoints revised (2)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Eligible subjects will be asked to take a placebo/treatment capsule for a total of 3 days and then participate in a study visit on the fourth day. This study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. Additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. The study will take approximately 3-4 hours and a designated driver will need to drive the participant home. On the fifth day, you will be asked to return to drop of the 24-hour urine collection.
Trial Details
NCT Number NCT05025865
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Healthy Controls
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov