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NCT04229095 · ClinicalTrials.gov registry record · Phase 2
Medication Development in Alcoholism: Suvorexant Versus Placebo
A Phase 2 study, sponsored by The Scripps Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT04229095: Completed Phase 2 study, sponsored by The Scripps Research Institute.
NCT04229095 is a Phase 2 study that has completed, run by The Scripps Research Institute. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04229095, a Phase 2 study, has completed, sponsored by The Scripps Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
VAS to alcohol cues minus VAS to water cues on a 0-20 VAS scale. Higher scores indicate greater craving strength with a minimum score of 0 and a maximum score of 20.
Interventions
- DRUG Placebo oral tablet
- DRUG Suvorexant 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2022-11-08 |
| Phase | Phase 2 |
What the finished NCT04229095 record still lists
NCT04229095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04229095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04229095 about?
NCT04229095 is a clinical study titled "Medication Development in Alcoholism: Suvorexant Versus Placebo". 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 (Bels...
What is the current status of trial NCT04229095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2021-11-17. Estimated completion is 2022-11-08.
What interventions are being tested in trial NCT04229095?
The interventions under investigation include: Placebo oral tablet (DRUG), Suvorexant 20 mg (DRUG).
Who is sponsoring clinical trial NCT04229095?
This trial is sponsored by The Scripps Research Institute, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04229095's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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