Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework
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.
Description
Double-blind placebo controlled study focusing on the ability of an already FDA approved medication for sleep disorders on AUD that will rigorously measure alcohol use, medication adherence, and sleep outcomes. Participants will come in for a baseline appointment that consists of informed consent and baseline data collection including blood, saliva, breath, and urine samples, as well as a brief medical history to determine safety in this study. Once approved for treatment, participants will be randomized into one of two arms, placebo + standard treatment or DTX + standard treatment. Both arm…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * DSM-5 diagnosis of an insomnia disorder (i.e., difficulty initiating/maintaining sleep, early morning awakening equal or greater than 3 nights a week for equal or greater than 3 months, daytime impairment, and exclusion of other causes) * Insomnia Severity Index (ISI) score equal or greater to 15 indicating the presence of moderate or severe insomnia * 4 or more standard drinks on 4 or more occasions in the past 30 days * Seeking insomnia and AUD treatment * Aged 18+ years * DSM-5 diagnosis of AUD * Ability to read and speak English * Breath Alcohol of 0.00 for informed…
Interventions
- DrugDaridorexant
Daridorexant 50mg (2 25mg tablets) taken once daily at night for the 12 week treatment phase.
- DrugPlacebo
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
- BehavioralBrief 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.
- DeviceMEMS 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.
Location
- WSU Research ClinicSpokane, Washington