Investigating the effects of Suvorexant on alcohol use
Official title: Influence of Orexin Antagonism on Motivation for Alcohol
Run by University of Kentucky · NCT06326684 · Data updated 2026-11-12
This study is testing if a medication called Suvorexant can help people with Alcohol Use Disorder feel less motivated to drink alcohol.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 55 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | June 7, 2024 |
| Main results expected | March 15, 2027 |
| Study ends | March 15, 2027 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT06326684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 to 55 who meet the DSM-5 criteria for moderate or severe Alcohol Use Disorder and have engaged in binge drinking recently.
✕Probably not a fit
Patients who are currently seeking treatment for alcohol use or have severe substance use disorders other than alcohol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research aims to provide initial clinical evidence that orexin antagonism can reduce motivation for alcohol and other maladaptive behaviors associated with Alcohol Use Disorder (AUD). The study will translate findings from preclinical research to humans, focusing on the orexinergic mechanisms that influence the pharmacodynamic effects of alcohol. Participants will receive either Suvorexant or a placebo while their responses to alcohol consumption will be monitored. The outcomes will enhance our understanding of the neurobiology underlying AUD and may inform future treatment strategies.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic approaches for individuals struggling with Alcohol Use Disorder.
How similar studies have gone: While the role of orexin in addiction has strong preclinical support, this approach remains novel and untested in human subjects.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion/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 Disorder; 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.
Where it's running
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Psychopharmacology of Addiction Laboratory
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: William W Stoops, PhD — University of Kentucky
- Study coordinator: William W Stoops, PhD
- Email: william.stoops@uky.edu
- Phone: 8592575388
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.