At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 8 enrolled
Drug / intervention
Lemborexant 10 mg +1 moredrug
Likely dose
Lemborexant 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep: A Randomized, Double-Blind, Placebo- Controlled Study
In Brief
A Phase 3 clinical trial evaluating Lemborexant 10 mg and Naltrexone for Alcohol Use Disorder. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedJul 2022
Enrollment StartFeb 2023
Primary CompletionJan 2024
TodayJul 2026
First PostedJul 14, 2022
Enrollment StartFeb 9, 2023
Primary CompletionJan 30, 2024
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 4.0 years ago
Interventions
Lemborexant 10 mgdrug
10 mg of Lemborexant
Naltrexonedrug
50 mg of Naltrexone