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Orexin Antagonist
Suvorexant Dose 2 for Alcoholism
Phase < 1
Waitlist Available
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.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 times over approximately 2.5 week inpatient admission.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 times over approximately 2.5 week inpatient admission.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reinforcing Effects of Alcohol
Secondary outcome measures
Alcohol Response
Blood pressure
Breath Alcohol Level
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Suvorexant Dose 2Experimental Treatment2 Interventions
Subjects will be treated with oral suvorexant dose 2.
Group II: Suvorexant Dose 1Experimental Treatment2 Interventions
Subjects will be treated with oral suvorexant dose 1.
Group III: PlaceboPlacebo Group2 Interventions
Subjects will be treated with an oral placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
2016
Completed Phase 4
~2120
Alcohol
2008
Completed Phase 3
~2000
Find a Location
Who is running the clinical trial?
University of KentuckyLead Sponsor
187 Previous Clinical Trials
226,934 Total Patients Enrolled
2 Trials studying Alcoholism
242 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
805 Previous Clinical Trials
1,365,882 Total Patients Enrolled
425 Trials studying Alcoholism
986,136 Patients Enrolled for Alcoholism
William W Stoops, PhDPrincipal InvestigatorUniversity of Kentucky
3 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Alcoholism
14 Patients Enrolled for Alcoholism
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals older than 35 years eligible to participate in this research trial?
"Participation in this study requires individuals to be above 21 years old but below 55 years of age."
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