Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

• Status: Not yet recruiting
• Trial end date: 2025-08-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Lemborexant; Naltrexone

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.