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Medication Development in Alcoholism: Suvorexant Versus Placebo

NCT04229095 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-04-26

Study results available
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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)

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • The Scripps Research Institute

    lead OTHER

Principal Investigators

  • Barbara J. Mason, Ph.D. · The Scripps Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2022-11-08
Completion
2022-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229095 on ClinicalTrials.gov