NCT06326684

Suvorexant and Alcohol

Influence of Orexin Antagonism on Motivation for Alcohol

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: William Stoops · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Interventions

Type	Name	Description
DRUG	Alcohol	The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.
DRUG	Placebo	The effects of placebo will be determined.
DRUG	Suvorexant	The effects of suvorexant dose 1 will be determined.
DRUG	Suvorexant	The effects of suvorexant dose 2 will be determined.

Timeline

• Start date: 2024-06-07
• Primary completion: 2027-03-15
• Completion: 2027-03-15
• First posted: 2024-03-22
• Last updated: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study