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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: Completed Phase 3 study, sponsored by Baylor College of Medicine.
NCT05458609 is a Phase 3 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 8 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Alcohol Urge Questionnaire (AUQ) total score (range 8-56; higher scores indicate greater craving) was assessed following alcohol-related virtual reality cue exposure at baseline and at multiple post-baseline time points during treatment. For this outcome, change from baseline to the last available post-baseline AUQ assessment was calculated and reported as a single summary value.
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 |
What the finished NCT05458609 record still lists
NCT05458609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Naltrexone is the first listed.
NCT05458609 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05458609's enrollment target sits among peer trials
8 1993rd of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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