Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
Public ClinicalTrials.gov record NCT04035200. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04035200
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 114 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 23, 2019 (Actual)
- Primary completion
- Nov 6, 2020 (Actual)
- Completion
- Nov 6, 2020 (Actual)
- Last update posted
- Sep 18, 2023
2019 – 2020
United States locations
- U.S. sites
- 17
- U.S. states
- 8
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91206 | — |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| CITrials | Santa Ana | California | 92705 | — |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Research Centers of America, LLC | Miami | Florida | 33157 | — |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | — |
| NeuroTrials Research Inc | Atlanta | Georgia | 30328 | — |
| Investigational Site | Chevy Chase | Maryland | 20815 | — |
| Sleep Disorders Centers of the Mid Atlantic | Glen Burnie | Maryland | 21061 | — |
| Wake Research - Clinical Research Center of Nevada, LLC | Las Vegas | Nevada | 89104 | — |
| SPRI Clinical Trials | Brooklyn | New York | 11235 | — |
| Clinilabs Drug Development Corporation | New York | New York | 10019 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | — |
| Advanced Medical Trials | Georgetown | Texas | 78628 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04035200, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04035200 live on ClinicalTrials.gov.