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Orexin Receptor Antagonist
Suvorexant for Alcoholism
Phase < 1
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post-treatment, up to 1.5-2 months.
Summary
This trial will explore if the drug suvorexant modifies brain and behavior targets of alcohol use disorder. Participants will complete tests and take the drug for 4 weeks before repeating the tests.
Who is the study for?
This trial is for adults aged 18-65 with moderate to severe alcohol use disorder (AUD), who drink heavily but are generally healthy. They must not be seeking AUD treatment, smoke little or no cigarettes, and agree to birth control if applicable. Exclusions include obesity, certain medication use, metal implants, claustrophobia, pregnancy, significant health conditions like liver disease or sleep apnea, and other mental health disorders.
What is being tested?
The study tests whether Suvorexant (SUV), an orexin receptor antagonist that affects brain-behavior stress responses in AUD patients can change their drinking behavior. Participants will randomly receive SUV or a placebo and undergo stress tests with EMG and possibly fMRI before and after taking the drug daily for four weeks.
What are the potential side effects?
Possible side effects of Suvorexant may include drowsiness, headaches, dizziness; it might also affect mood or sleep patterns. Side effects will be monitored through daily smartphone reports during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to post-treatment, up to 1.5-2 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-treatment, up to 1.5-2 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol behavior and daily use of suvorexant.
Startle reactivity to stress with an acute dose of suvorexant.
Startle reactivity to stress with daily use of suvorexant.
Secondary study objectives
Brain change and daily use of suvorexant.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Suvorexant TreatmentExperimental Treatment1 Intervention
Individuals will take 10mg of suvorexant (Merck \& Co Inc.) during the Acute Drug Challenge and daily for 28 days.
Group II: ControlPlacebo Group1 Intervention
Individuals will take a placebo pill during the Acute Drug Challenge and daily for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suvorexant
2016
Completed Phase 4
~2200
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,668 Total Patients Enrolled
3 Trials studying Alcoholism
418 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am deaf in one or both ears.I have been diagnosed with a serious mental health condition like schizophrenia or major depression.I am between 18 and 65 years old.I drink 14 or more drinks weekly if male, or 7 or more if female.I do not have severe liver disease, narcolepsy, severe sleep apnea, or similar serious conditions.I am currently taking antihistamines, certain liver enzyme inhibitors, or digoxin.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Suvorexant Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.