Clinical trial NCT04229095: Medication Development in Alcoholism: Suvorexant Versus Placebo
Official title: Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder (AUD)
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-01-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.
* 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS) of Craving Severity: 2 Arms
timeFrame: 1 hour during cue reactivity session
measure: Visual Analog Scale (VAS) Strength of Craving: Combined Arms Conditional Model
timeFrame: 1 hour during cue reactivity session
Secondary outcomes:
measure: Number of Standard Drinks Per Day: 2 Arms
timeFrame: Up to one week following single dose administration
measure: Number of Standard Drinks Per Day: Combined Arms Conditional Model
timeFrame: Up to one week following single dose administration
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Research
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: