Investigating the effects of Suvorexant on alcohol use

Influence of Orexin Antagonism on Motivation for Alcohol

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
• Enrollment: 30 (estimated)
• Ages: 21 Years to 55 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT06326684 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While the role of orexin in addiction has strong preclinical support, this approach remains novel and untested in human subjects.

Eligibility 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 this trial is running

Lexington, Kentucky

• 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

Conditions Alcohol Use Disorder