Phase 3
Completed N=7
Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
Source: ClinicalTrials.gov NCT05458609 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Cue-induced Alcohol Cravings Using the Alcohol Urge Questionnaire — -22.67; -23.67 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cue-induced Alcohol Cravings Using the Alcohol Urge Questionnaire |
-22.67; -23.67 | — |
| PRIMARY Non-Cued Alcohol Cravings Using the Penn Alcohol Craving Scale |
-14.00; -12.33 | — |
| SECONDARY Actigraphy to Measure Total Sleep Time |
8.40; 8.75 | — |
| SECONDARY Actigraphy to Measure Total Awakenings After Sleep Onset During the Study Period |
237.67; 422.00 | — |
Eligibility Criteria
Inclusion Criteria
- Admission to The Menninger clinic
- Age 18-65 years
- diagnosis of alcohol use disorder using the DSM-5 criteria confirmed with SCID-5 and
- Diagnosis of insomnia using the DSM 5 criteria, confirmed with SCID-5
Exclusion Criteria
- unstable medical conditions (e.g. liver enzymes (ALT and AST) more than 3 times normal)
- acute alcohol withdrawal
- another drug use disorder other than nicotine and cannabis
- use of either of the study medications, naltrexone or lemborexant, within the last 30 days
- Use of any opioid medication within the past 10 days
- Use of scheduled benzodiazepines and hypnotics
- Breathalyzer positive for alcohol
- Known sensitivity to naltrexone or lemborexant
- Pregnant or breastfeeding
- Diagnosis of narcolepsy. The presence of other psychiatric illnesses, use of other psychotropic medications, and stable medical conditions will not be excluded.
Data sourced from ClinicalTrials.gov (NCT05458609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.