Medication Development in Alcoholism: Suvorexant Versus Placebo

Overview

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.

Full Title of Study: “Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2022

Interventions

  • Drug: Suvorexant 20 mg
    • Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit
  • Drug: Placebo oral tablet
    • Single-dose administration of placebo given on an inpatient clinical research unit

Arms, Groups and Cohorts

  • Active Comparator: Belsomra,(suvorexant)
    • 20 mg single-dose administration given on an inpatient clinical research unit
  • Placebo Comparator: Placebo
    • Placebo single-dose administration given on an inpatient clinical research unit

Clinical Trial Outcome Measures

Primary Measures

  • Craving to drink
    • Time Frame: 1 week
    • Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum core of 0 and a maximum score of 80.

Secondary Measures

  • Drinking
    • Time Frame: 2 weeks
    • Number of standard drinks per week using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per week with a minimum value of 0 and an undetermined maximum value.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female volunteers, 18-65 years of age.
  • Meets 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 BAC and a 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-V 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.
  • Willing to comply with the provisions of the protocol and take oral medication.

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.
  • Failure to take double-blind medication as prescribed.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Scripps Research Institute
  • Collaborator
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Barbara J. Mason, Ph.D., Principal Investigator, The Scripps Research Institute
  • Overall Contact(s)
    • Susan Quello, B.A., B.S., 858-784-7327, squello@scripps.edu

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