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NCT05458609 · ClinicalTrials.gov registry record · Phase 3
Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
A Phase 3 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 8
- Enrollment target
NCT05458609 is a Phase 3 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 8 participants.
The verdict
NCT05458609, a Phase 3 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this study to evaluate the effects of naltrexone plus lemborexant augmentation compared to naltrexone plus placebo on cue-induced and non-cued alcohol cravings in people with alcohol use disorder and insomnia. Our secondary goals are to evaluate the effects of lemborexant plus naltrexone combination on sleep quality using self-report questionnaires and actigraph data, depression, anxiety, and suicidal ideation.
Interventions
- DRUG Naltrexone
- DRUG Lemborexant 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05458609
The ClinicalTrials.gov registry entry for NCT05458609 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Naltrexone is the first listed.
NCT05458609 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05458609 about?
NCT05458609 is a clinical study titled "Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep". The purpose of this study to evaluate the effects of naltrexone plus lemborexant augmentation compared to naltrexone plus placebo on cue-induced and non-cued alcohol cravings in people with alcohol use disorder and insomnia. Our secondary goals are to evaluate the effects of lemborexant plus naltrex...
What is the current status of trial NCT05458609?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8 participants. The study started on 2023-02-09. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT05458609?
The interventions under investigation include: Naltrexone (DRUG), Lemborexant 10 mg (DRUG).
Who is sponsoring clinical trial NCT05458609?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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