Medication Development in Alcoholism: Suvorexant Versus Placebo

NCT04229095 | Completed Phase 2 Results FDA Drug

• 1 other identifier: P60AA006420
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS) of Craving Severity: 2 Arms

  VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.

  1 hour during cue reactivity session

• Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model

  VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.

  1 hour during cue reactivity session

Secondary Outcomes (2)

• Number of Standard Drinks Per Day: 2 Arms

  Up to one week following single dose administration

• Number of Standard Drinks Per Day: Combined Arms Conditional Model

  Up to one week following single dose administration

Study Arms (2)

Belsomra,(suvorexant)

ACTIVE COMPARATOR

20 mg single-dose administration given on an inpatient clinical research unit

Drug: Suvorexant 20 mg

Placebo

PLACEBO COMPARATOR

Placebo single-dose administration given on an inpatient clinical research unit

Drug: Placebo oral tablet

Interventions

Suvorexant 20 mg DRUG

Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit

Also known as: Belsomra

Belsomra,(suvorexant)

Placebo oral tablet DRUG

Single-dose administration of placebo given on an inpatient clinical research unit

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to comply with the provisions of the protocol and take oral medication.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Scripps Research

La Jolla, California, 92037-4657, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

suvorexant; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

The actual enrollment was 26 subjects, relative to the planned enrollment of 50 subjects, due to chronic staffing problems for overnight studies at the Altman Clinical and Translational Research Institute (ACTRI) at the University of California-San Diego (UCSD) that resulted in multiple pre-randomization visit cancellations. Alternative inpatient beds were not available at general hospitals due to the prioritization of their facilities for COVID-19 patients.

Results Point of Contact

• Title: Dr. Barbara J. Mason, Ph.D. Professor
• Organization: The Scripps Research Institute

mason@scripps.edu

(858 784-7324

Study Officials

• Barbara J. Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Double-Blind, Randomized Stratified at randomization based on sex and Pittsburgh Sleep Quality Index Total Score (PSQI) greater than or equal to 5 versus less than 5.

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: November 17, 2021
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: April 26, 2023
• Results First Posted: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)