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Daridorexant for People With Insomnia and Alcohol Use Disorder Study
Sponsor: Sterling McPherson
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.
Official title: Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
205
Start Date
2026-09-01
Completion Date
2031-12
Last Updated
2026-07-14
Healthy Volunteers
No
Conditions
Interventions
Daridorexant
Daridorexant 50mg (2 25mg tablets) taken once daily at night for the 12 week treatment phase.
Placebo
Placebo medication used as comparator for active treatment (DTX). Will be distributed as 2 25mg tablets taken once daily at night similar to the active treatment medication
Brief Counseling
All participants, regardless of group assignment will receive an equivalent dose of brief, manualized counseling made available by NIAAA called Take Control at equivalent intervals during the treatment period. Counseling will require 15 minutes every other week (6 sessions total across the 12-week treatment plan) and will include reminders about the importance of medication adherence.
MEMS and Medication Accounting
All participants will receive the Medication Event Monitoring System (MEMS) bottle cap device at their first treatment period visit and receive a brief, 10-minute introduction on how to use the device. All participants will be instructed to take prescribed medication. At each subsequent visits, research staff will use a calendar to review the study medications taken since last visit using a timeline followback (TLFB) approach, verified electronically with the MEMS device providing medication adherence reports to research staff.
Contingency Management for Medication Adherence
During the treatment period, each participant will receive electronic gift cards in exchange for demonstrating 85% adherence to prescribed medication over the past 14 days of remote observation. Adherence data will be available through the MEMS device portal.
Locations (1)
WSU Research Clinic
Spokane, Washington, United States