NCT04229095

Medication Development in Alcoholism: Suvorexant Versus Placebo

Medication Development for Protracted Abstinence in Alcoholism: Suvorexant Versus Placebo

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: The Scripps Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-17
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2020-01-14
• Last updated: 2023-04-26
• Results posted: 2023-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study