drugset / Trial / NCT07701928

Daridorexant for People With Insomnia and Alcohol Use Disorder Study

NCT07701928

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to see if a sleep medication, daridorexant (DTX), can help decrease drinking in people who have alcohol use disorder (AUD) and insomnia. The main questions it aims to answer are: * Can DTX decrease alcohol use in individuals with insomnia better than placebo? * Can DTX increase sleep time and other sleep related outcomes better than placebo? Participants will: * Take prescribed medication (DTX or Placebo based on which group they are randomized to). * Provide urine, breath, saliva, and blood samples. * Come in for bi-weekly (once every 2 weeks) in-person visits. * Answer questionnaires and surveys related to sleep, substance use, and physical/mental health. * Use an EEG headband to track brain activity at night. * Come in for 3 follow up visits one month, six months, and one year after treatment.

Timeline

Start
2026-09-01
Primary completion
2030-12
Completion
2031-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Daridorexant Small molecule 50 mg