Suvorexant and Alcohol
This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.
Conditions:
🦠 Alcohol Use Disorder
πŸ—“οΈ Study Start (Actual) 7 June 2024
πŸ—“οΈ Primary Completion (Estimated) 15 March 2027
βœ… Study Completion (Estimated) 15 March 2027
πŸ‘₯ Enrollment (Estimated) 30
πŸ”¬ Study Type INTERVENTIONAL
πŸ“Š Phase EARLY_PHASE1
Locations:
πŸ“ Lexington, Kentucky, United States

πŸ“‹ Eligibility Criteria

Description

Exclusion Criteria:

  • 1. Able to speak and read English.
  • 2. Not seeking treatment at the time of the study.
  • 3. Between the ages of 21 and 55 years.
  • 4. Engaging in at least one binge drinking episode, per the NIAAA definition, in the last 30 days.
  • 5. Fulfillment of moderate or severe DSM-5 diagnostic criteria for AUD based on computerized SCID results reviewed by a psychiatrist or psychologist.
  • 6. ECG, read by cardiologist, within normal limits.
  • 7. Body mass index of 19 - 35.
  • 8. Birthing individuals using an effective form of birth control and not pregnant or breast feeding.
  • 9. Judged by the medical staff to be psychiatrically and physically healthy (i.e., no current severe SUD or psychiatric diagnoses other than AUD or Tobacco Use DisorderΝΎ no current physical diagnoses that would interfere with study participation according to study physician judgment).
  • 10. Not currently physiologically dependent on any substances.
  • 11. Able to abstain from alcohol during admission (i.e., not physically dependent on alcohol and scores less than 8 on Clinical Institute Withdrawal Assessment for Alcohol \[CIWA-Ar\] at screening).
  • 12. Not currently taking any prescribed medications for a chronic condition (other than birth control).
  • 13. No indication of sleep apnea on the STOP-Bang questionnaire (score of 5 or greater).
  • 14. No contraindications/allergies to suvorexant.
Ages Eligible for Study: 21 Years to 55 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 March 2024
  • First Submitted that Met QC Criteria 15 March 2024
  • First Posted 22 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 June 2024
  • Last Update Posted 10 June 2024
  • Last Verified June 2024