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Orexin Antagonist

Suvorexant for Alcoholism

Phase < 1
Recruiting
Led By William W Stoops, PhD
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 times over approximately 2.5 week inpatient admission.

Summary

"This trial aims to investigate how blocking orexin, a brain chemical, can reduce the desire for alcohol and related behaviors in people with Alcohol Use Disorder. The study will also provide insights into how orexin

Who is the study for?
This trial is for English-speaking adults aged 21-55 with Alcohol Use Disorder (AUD) who are not pregnant, breastfeeding, or have sleep apnea. Participants must be healthy overall, not dependent on alcohol or other substances, and not seeking treatment. They should have had at least one binge drinking episode recently but can't be taking chronic medication except birth control.
What is being tested?
The study is testing the effects of a drug called suvorexant on people with AUD to see if it reduces their desire for alcohol and related negative behaviors. It aims to understand how orexin (a brain chemical linked to addiction) affects alcohol's influence on humans.
What are the potential side effects?
While specific side effects aren't listed here, suvorexant generally may cause drowsiness, headaches, dizziness, dry mouth, and in some cases more serious reactions like sleepwalking or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 times over approximately 2.5 week inpatient admission.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 times over approximately 2.5 week inpatient admission. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reinforcing Effects of Alcohol
Secondary study objectives
Alcohol Response
Blood pressure
Breath Alcohol Level
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Suvorexant Dose 2Experimental Treatment2 Interventions
Subjects will be treated daily with oral suvorexant (20 mg).
Group II: Suvorexant Dose 1Experimental Treatment2 Interventions
Subjects will be treated daily with oral suvorexant (10 mg).
Group III: PlaceboPlacebo Group2 Interventions
Subjects will be treated daily with an oral placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alcohol
2008
Completed Phase 3
~1990
Suvorexant
2016
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor
192 Previous Clinical Trials
223,592 Total Patients Enrolled
3 Trials studying Alcoholism
297 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,740 Total Patients Enrolled
456 Trials studying Alcoholism
823,756 Patients Enrolled for Alcoholism
William W Stoops, PhDPrincipal InvestigatorUniversity of Kentucky
3 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Alcoholism
14 Patients Enrolled for Alcoholism
~20 spots leftby Mar 2027
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