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CompletedEarly phase 1

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