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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 is a Phase 2 study that has completed, run by The Scripps Research Institute. The registered enrollment target is 26 participants.

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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.

Interventions

  • DRUG Placebo oral tablet
  • DRUG Suvorexant 20 mg

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2021-11-17
Est. Completion 2022-11-08
Phase Phase 2

Sponsor

The Scripps Research Institute

16 total trials

What the Registry Record Tells You About NCT04229095

The ClinicalTrials.gov registry entry for NCT04229095 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Scripps Research Institute, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.

NCT04229095 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.