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Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 124 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 5 words
  3. 12 versions Re-verified since Sep 12, 2025, no change to tracked fieldsv111-v122
  4. Enrollment target: 150 to 180v110
  5. Eligibility criteria expanded, about 32 words
    • Study description revised
    v109
Show 34 earlier versionsHide 34 earlier versions
  1. 3 versions Re-verified since May 28, 2025, no change to tracked fieldsv106-v108
  2. Primary completion date: Dec 31, 2031 to Dec 31, 2028v105 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Dec 31, 2032 to Dec 31, 2029
    • Secondary endpoint revised
    • Site contact updated
    • Study arms: 4 to 3
  3. Eligibility criteria expanded, about 3 wordsv104
  4. Primary completion date: Dec 31, 2028 to Dec 31, 2031
    • Study completion date: Dec 31, 2029 to Dec 31, 2032
    • Study arms: 3 to 4
    v103
  5. Eligibility criteria shortened, about 3 wordsv102
  6. Study Status, Eligibilityv101
  7. 4 versions Re-verified since Nov 28, 2024, no change to tracked fieldsv97-v100
  8. Start date changed from estimate of Nov 28, 2024 to Nov 21, 2024v96
  9. Start date: Nov 26, 2024 to Nov 28, 2024v95
  10. Start date: Nov 25, 2024 to Nov 26, 2024v94
  11. Start date: Nov 24, 2024 to Nov 25, 2024v93
  12. Start date: Nov 21, 2024 to Nov 24, 2024v92
  13. Start date: Nov 20, 2024 to Nov 21, 2024v91
  14. Start date: Nov 19, 2024 to Nov 20, 2024v90
  15. Start date: Nov 18, 2024 to Nov 19, 2024v89
  16. Start date: Nov 17, 2024 to Nov 18, 2024v88
  17. Start date: Nov 14, 2024 to Nov 17, 2024v87
  18. Start date: Nov 13, 2024 to Nov 14, 2024v86
  19. Start date: Nov 12, 2024 to Nov 13, 2024v85
  20. Start date: Nov 11, 2024 to Nov 12, 2024v84
  21. Start date: Nov 10, 2024 to Nov 11, 2024v83
  22. Start date: Nov 7, 2024 to Nov 10, 2024v82
  23. Start date: Nov 5, 2024 to Nov 7, 2024v81
  24. Start date: Nov 4, 2024 to Nov 5, 2024v80
  25. Start date: Nov 3, 2024 to Nov 4, 2024v79
  26. Start date: Oct 31, 2024 to Nov 3, 2024v78
  27. Start date: Oct 30, 2024 to Oct 31, 2024v77
  28. Start date: Oct 29, 2024 to Oct 30, 2024v76
  29. Start date: Oct 28, 2024 to Oct 29, 2024v75
  • 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.
Background: Alcohol use disorder (AUD) is a leading cause of disease and death worldwide. New treatments for AUD are needed. Dopamine, a chemical that carries signals between brain cells, is thought to play a role in alcohol addiction. Researchers want to learn how Suvorexant, a drug used to treat sleep disorders, affects dopamine receptors in the brain. Objective: To see how Suvorexant affects dopamine receptors in people with AUD and in healthy people. Eligibility: People aged 18 to 75 years seeking treatment for AUD. Healthy volunteers are also needed. Design: Participants with AUD will stay in the clinic for at least 10-28 days for alcohol detoxification. They will receive normal treatment for AUD. Suvorexant is a medicine used to treat sleep problem that is taken taken by mouth, once a day. Some participants will take the study drug. Others will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking. Participants will wear a device that looks like a wristwatch to track their movements during their clinic stay. Participants will have blood tests and 3 brain imaging scans before starting on the study drug: 2 positron emission tomography (PET) and 1 magnetic resonance imaging (MRI) scan. They will be injected with a radioactive tracer during each PET scan. Participants will have tests to assess their thinking, memory, and attention. They will have sleep studies. Imaging scans and other tests will be repeated at the end of the study. Healthy volunteers will have 1 MRI and 2 PET scans. They will have tests to assess of their thinking, memory, and attention. They will wear a wristwatch like movement monitor for 1 week. ...
Trial Details
NCT Number NCT06484075
Lead Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Healthy Volunteers, Alcohol Use Disorder (AUD)
Related terms Alcoholism
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov