Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use Disorder
Key facts
- Who runs it
- Ohio State University
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Early phase 1
- People taking part
- 81 people enrolled
- Started
- 29 Nov 2022
- Ended
- 1 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Suvorexant
- Placebo
- Record updated
- 30 October 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age 18-65
- Participant is able to give informed consent
- Generally medically and physically healthy as confirmed by medical history
- Meet DSM-5 diagnostic criteria for current moderate or severe AUD
- Engage in heavy alcohol use defined as drinking equal or greater than 14 standard drinks per week if male and equal or greater than 7 standard drinks per week if female
Who cannot take part
- Current use of antihistamines, strong or moderate inhibitors of CYP3A liver enzymes, strong CYP3A inducers, or digoxin
- Recent psychotropic medication use in the past 2 months
- Clinically significant medical or neurological condition (e.g., liver disease, narcolepsy, complex sleep behaviors, severe hepatic impairment, COPD, severe obstructive sleep apnea)
- Current cognitive dysfunction (traumatic brain injury, mental retardation, organic mental syndrome, pervasive developmental disorder, or dementia)
- Current or past DSM-5 diagnosis of mania, schizophrenia, psychosis, suicidality, major depressive disorder, or obsessive compulsive disorder
- Current substance use disorder other than alcohol or mild cannabis use disorder
- Treatment seeking for AUD
- Currently smokes 5 or more cigarettes (or electronic equivalent) per day
- BMI equal or greater than 35
- Engage in night-shift work
- Lack of fluency in English
- Presence of ferrous-containing metal in the body
- Inability to tolerate small, enclosed spaces
- Deafness in one or both ears
- Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial
Where in United States
- The Ohio State UniversityColumbus, United States
About the trial
What the trial wants to find out
The goal of this double-blind clinical trial is to further explore if, how, and for whom orexin antagonism modifies brain-behavior stress targets in moderate to severe alcohol use disorder (AUD). The main questions it aims to answer are:
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* Does an acute dose of suvorexant (SUV) and/or daily use of SUV modify brain-behavior targets of AUD dysfunction? * Does daily SUV use change alcohol behavior and if so, is this change in behavior linked to brain-behavior change?
Participants will be randomized to a treatment group (SUV or placebo) and protocol arm, electromyography (EMG) only or EMG+functional magnetic resonance imaging (fMRI). Participants will be asked to complete the following:
* Baseline lab visit(s) that include the psychophysiological stress paradigm (EMG only or EMG+fMRI, dependent upon randomization). * Acute drug challenge where the participant will return to the lab to repeat the stress paradigm following administration of a single dose of either 10mg SUV or placebo. * Medication trial where participants will be instructed to take 10mg capsules of SUV or placebo orally each night before bedtime for 4-weeks. * Daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 4-week medication trial. * Post-treatment lab visit(s) where participants will return to the lab at the end of the medication trial and complete the same stress paradigm from baseline (EMG only or EMG+fMRI, dependent upon randomization).
The 2 groups in the trial
- ControlPlacebo, for comparison
Individuals will take a placebo pill during the Acute Drug Challenge and daily for 28 days.
Treatment: Placebo
- Suvorexant TreatmentTreatment being tested
Individuals will take 10mg of suvorexant (Merck \& Co Inc.) during the Acute Drug Challenge and daily for 28 days.
Treatment: Suvorexant
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 October 2025