Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep
Completed · Phase 3 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
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.
Key facts
- Study ID
- NCT05458609
- Run by
- Baylor College of Medicine
- People needed
- 8
- Starts
- 2023-02-09
- Expected to finish
- 2024-01-30
- Last updated by the study team
- 2026-03-24
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Menninger Clinic — Houston, Texas, United States
Full record on ClinicalTrials.gov
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