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Medication Development in Alcoholism: Suvorexant Versus Placebo | Clinical Trials | Clareo Health

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Medication Development in Alcoholism: Suvorexant Versus Placebo

Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo

NCT04229095•The Scripps Research Institute

Summary

The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality Index total score of \> 5 versus \<5. Subjects were also stratified by sex.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female volunteers, 18-65 years of age.
•Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).
•In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
•Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
•Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.
•Negative blood alcohol content (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of \< 9 at time of randomization and lab session to eliminate acute alcohol or withdrawal effects on dependent measures.
•In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.
•Subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current DSM-5 criteria for depression or anxiety.
•Females with childbearing potential must have a negative pregnancy test on the screening and randomization visits and agree to use effective birth control for the duration required by a given study.
•Able to provide informed consent and understand questionnaires and study procedures in English.
+1 more criteria

Exclusion Criteria

•Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine, or, mild cannabis use disorder
•Has a urine drug screen (UDS) positive for substances of abuse other than alcohol or marijuana
•Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician.
•Liver function tests more than 3 times the upper limit of normal or elevated bilirubin.
•Subjects taking digoxin or CYP3A inhibitors or inducers, metabolism by CYP3A is the major elimination pathway for suvorexant.
•Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram \[Antabuse\], naltrexone \[ReVia\], acamprosate \[Campral\], or anticonvulsants).
•Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.
•Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration of the study.
•No fixed domicile and/or no availability by home or mobile telephone.
•History of hypersensitivity to the study drug or the ingredients.
+1 more criteria

Locations (1)

Scripps Research

La Jolla, California, United States

Key Dates

Start Date

November 17, 2021

Primary Completion Date

November 8, 2022

Completion Date

November 8, 2022

Last Updated

April 26, 2023

Enrollment

ACTUAL participants

Conditions

Alcohol Use Disorder (AUD)

Interventions

Suvorexant 20 mg

DRUG

Placebo oral tablet

DRUG

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

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Alcohol Use Disorder (AUD)Cocaine Use Disorder (CUD)+1 more

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RECRUITINGNA

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Alcohol Use Disorder (AUD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Medication Development in Alcoholism: Suvorexant Versus Placebo

Inclusion Criteria

Exclusion Criteria

Web-based Alcohol- or Cocaine-specific Inhibition Training in Adolescents and Young Adults With Substance Use Disorder

Combining a Smartphone App With Medications to Manage Heavy Drinking

iTBS for Alcohol Use Disorder

Attentional Control Training for Treating Alcohol Use Disorder

Assessing Habitual, Goal-Directed, and Pavlovian Influences in Alcohol Use Disorder

Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer