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Suvorexant for Alcohol Use Disorder and Stress-Related Drinking

This study is exploring whether suvorexant (SUV) can help treat alcohol use disorder (AUD) and reduce stress-related drinking. Researchers want to see if SUV is effective, if it lessens your body's reaction to stress, and if they can find a way to predict who will respond best to the treatment. You would take 10mg capsules of suvorexant or a placebo (a pill with no active drug) every night for 8 weeks. The study includes lab visits before, during, and after treatment to check your progress. To join, you need to be between 18 and 65 years old, have a moderate to severe AUD diagnosis, and drink heavily (at least 14 drinks/week for men, 7 drinks/week for women). The study aims to enroll 250 participants.

Study design
This is a double-blind study, meaning neither you nor your doctor will know if you are receiving suvorexant or a placebo. It plans to enroll 250 participants.
What's involved
You would take a capsule nightly for 8 weeks and attend lab visits before treatment, at 4 weeks, and at 8 weeks. These visits include a psychophysiological stress paradigm (electromyography; EMG).
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured during the 8-week treatment period and at the end of this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214207

Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Ohio State University
~250 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:Suvorexant 10 mgPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Heavy Drinking Days
Measured over 8-week treatment period
+2 more outcomes measured

Conditions

Alcohol Use Disorder

Explore related trials

Alcohol use disorder

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Stephanie Gorka
[email protected]
614-366-1027
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Generally medically and neurologically healthy;
Age 18 to 65 at the time of consent;
Willing and able to give informed consent;
Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
Self-reported treatment-seeking for alcohol use disorder

Exclusion

Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders;
Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined by the study physician;
Current use of strong or moderate inhibitors of CYP3A liver enzymes;
Current use of strong CYP3A inducers;
Current use of digoxin;
Liver function tests more than 3 times the upper limit of normal or elevated bilirubin;
Engages in night shift work;
Smoke 10 or more cigarettes (or electronic equivalent) per day and are thus susceptible to acute nicotine withdrawal during lab visits;
Obesity as defined by a body-mass index (BMI) equal or greater than 30, as calculated from weight and height self-report;
Clinically significant alcohol withdrawal symptoms the day of the lab sessions, defined as a score \>10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar);
Unwilling/unable to sign the informed consent document;
Under 18 years old or over 65 years old at the time of enrollment;
Have attempted suicide in the past 3 years and/or have current suicidal ideation determined as greater than moderate via the Columbia Suicide Severity Rating Scale (C-SSRS)

What this trial measures

  • Proportion of Heavy Drinking Days8-week treatment period

    Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days.

  • Startle eyeblink potentiationBaseline; 4-weeks; 8-weeks

    Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.

  • Alcohol Craving Via Ecological Momentary Assessment (EMA)8-week treatment period

    Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving).