Conditions: Insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of V117957 in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation, compared to placebo.

Detailed description:

Arms:
arm 1: V117957 tablets taken orally at bedtime arm 2: V117957 tablets taken orally at bedtime arm 3: Placebo to match V117957 tablets taken orally at bedtime

Interventions: intervention 1: V117957 tablets intervention 2: Placebo
Intervention descriptions: intervention 1: V117957 tablets taken orally at bedtime intervention 2: Tablets to match V117957

Protocol document:
Prot_SAP_000.pdf: 
Official Title:  A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-
Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of 
V117957 in Subjects with an Alcohol Use Disorder who are Experiencing Insomnia 
Associated with Alcohol Cessation
NCT #: NCT04035200
Date of Document: September 27, 2019