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Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 117 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 6 versions Re-verified since Apr 16, 2026, no change to tracked fieldsv112-v117
  2. Minor Study description expanded, about 32 wordsv111
  3. Minor Start date changed from estimate of Dec 18, 2025 to Dec 11, 2025v110
  4. Minor Start date: Dec 16, 2025 to Dec 18, 2025v109
  5. Minor Start date: Dec 15, 2025 to Dec 16, 2025v108
Show 40 earlier versionsHide 40 earlier versions
  1. Minor Start date: Dec 14, 2025 to Dec 15, 2025v107
  2. Minor Start date: Dec 11, 2025 to Dec 14, 2025v106
  3. Minor Start date: Dec 10, 2025 to Dec 11, 2025v105
  4. Minor Start date: Dec 9, 2025 to Dec 10, 2025v104
  5. Minor Start date: Dec 8, 2025 to Dec 9, 2025v103
  6. Minor Start date: Dec 7, 2025 to Dec 8, 2025v102
  7. Minor Start date: Dec 3, 2025 to Dec 7, 2025v101
  8. Minor Start date: Dec 2, 2025 to Dec 3, 2025v100
  9. Minor Start date: Dec 1, 2025 to Dec 2, 2025v99
  10. Minor Start date: Nov 30, 2025 to Dec 1, 2025v98
  11. Minor Start date: Nov 27, 2025 to Nov 30, 2025v97
  12. Minor Start date: Nov 26, 2025 to Nov 27, 2025v96
  13. Minor Start date: Nov 25, 2025 to Nov 26, 2025v95
  14. Minor Start date: Nov 24, 2025 to Nov 25, 2025v94
  15. Minor Start date: Nov 23, 2025 to Nov 24, 2025v93
  16. Minor Start date: Nov 20, 2025 to Nov 23, 2025v92
  17. Minor Start date: Nov 19, 2025 to Nov 20, 2025v91
  18. Minor Start date: Nov 18, 2025 to Nov 19, 2025v90
  19. Minor Start date: Nov 17, 2025 to Nov 18, 2025v89
  20. Minor Start date: Nov 13, 2025 to Nov 17, 2025v88
  21. Minor Start date: Nov 12, 2025 to Nov 13, 2025v87
  22. Minor Start date: Nov 11, 2025 to Nov 12, 2025v86
  23. Minor Start date: Nov 10, 2025 to Nov 11, 2025v85
  24. Minor Start date: Nov 9, 2025 to Nov 10, 2025v84
  25. Minor Start date: Nov 6, 2025 to Nov 9, 2025v83
  26. Minor Start date: Nov 5, 2025 to Nov 6, 2025v82
  27. Minor Start date: Nov 4, 2025 to Nov 5, 2025v81
  28. Minor Start date: Nov 3, 2025 to Nov 4, 2025v80
  29. Minor Start date: Nov 2, 2025 to Nov 3, 2025v79
  30. Minor Start date: Oct 30, 2025 to Nov 2, 2025v78
  31. Minor Start date: Oct 29, 2025 to Oct 30, 2025v77
  32. Minor Start date: Oct 28, 2025 to Oct 29, 2025v76
  33. Minor Start date: Oct 27, 2025 to Oct 28, 2025v75
  34. Minor Start date: Oct 26, 2025 to Oct 27, 2025v74
  35. Minor Start date: Oct 23, 2025 to Oct 26, 2025v73
  36. Minor Start date: Oct 22, 2025 to Oct 23, 2025v72
  37. Minor Start date: Oct 21, 2025 to Oct 22, 2025v71
  38. Minor Start date: Oct 20, 2025 to Oct 21, 2025v70
  39. Minor Start date: Oct 19, 2025 to Oct 20, 2025v69
  40. Minor Start date: Oct 15, 2025 to Oct 19, 2025v68
  • 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: Phosphodiesterase-4B (PDE4B) is a protein in the brain that may play a role in several mental health disorders. Researchers want to know if drinking alcohol increases the binding of a radioactive tracer to PDE4B in the brain because of increased activity and/or amount of the protein. This knowledge may help create new ways to treat people with alcohol use disorder (AUD). Objective: To learn if alcohol increases PDE4B activity in the brain. Eligibility: Healthy people aged 21 to 70 years who drink socially but do not have AUD. They must be enrolled in protocol 14-AA-0181"NIAAA Natural History Protocol". Design: Participants will have up to 4 clinic visits with up to 3 imaging scans of the brain; these will include 1 or 2 positron emission tomography (PET) scans and 1 magnetic resonance imaging (MRI) scan. The first PET scan will be a baseline. Participants will receive a radioactive tracer through a tube inserted into a vein. A second tube will be inserted so that blood can be drawn during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. This visit will take about 6 hours. For the next PET scan, participants will receive alcohol (ethanol) through a tube in a vein until they have a blood alcohol concentration that is equal to the legal driving limit. This is the same as 4 or 5 drinks for most people. After the scan, participants must remain at the clinic for a few hours until their blood alcohol drops. This visit will take 14 to 16 hours. The MRI scan of the brain will take up to 2 hours in a separate clinic visit.
Trial Details
NCT Number NCT07027839
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Alcohol Use Disorder
Related terms Alcoholism
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov