CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Recruiting· 30 target
Drug / intervention
Alcohol +3 moredrug
Likely dose
Alcohol 0.4 gfrom record
Key inclusion· 12
  • Able to speak and read English
  • Between ages 21 and 55 years
  • At least one binge drinking episode per NIAAA definition in last 30 days
  • Moderate or severe DSM-5 AUD based on computerized SCID
Key exclusion· 2
  • Seeking treatment at time of study
  • Contraindications or allergies to suvorexant

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06326684
NCT06326684Early Ph 1RecruitingOn Track

Influence of Orexin Antagonism on Motivation for Alcohol

William Stoops·interventional·Posted Mar 22, 2024·Updated Jun 8, 2026

In Brief

A Early Phase 1 clinical trial evaluating Alcohol, Placebo, and 1 other intervention for Alcohol Use Disorder. Currently recruiting, targeting 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1Recruiting
202520262027
First PostedMar 22, 2024
Enrollment StartJun 7, 2024
Primary CompletionMar 15, 2027
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 2.3 years agoPrimary completion in 8 months

Arms & Interventions

Placeboplacebo_comparator

Subjects will be treated daily with an oral placebo.

Drug: AlcoholDrug: Placebo
Suvorexant Dose 1experimental

Subjects will be treated daily with oral suvorexant (10 mg).

Drug: AlcoholDrug: Suvorexant
Suvorexant Dose 2experimental

Subjects will be treated daily with oral suvorexant (20 mg).

Drug: AlcoholDrug: Suvorexant

Interventions

Alcoholdrug

The pharmacodynamic effects of alcohol (0.2 and 0.4 g/kg) will be determined.

Placebodrug

The effects of placebo will be determined.

Suvorexantdrug

The effects of suvorexant dose 1 will be determined.

Suvorexantdrug

The effects of suvorexant dose 2 will be determined.