Daridorexant for People With Insomnia and Alcohol Use Disorder Study
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder, Insomnia
In brief
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.
Key facts
- Study ID
- NCT07701928
- Run by
- Sterling McPherson
- People needed
- 205
- Starts
- 2026-09-01
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 consent
- Ability to provide written informed consent
- Non-lactating women of childbearing age using a reliable form of birth control with a negative serum pregnancy test at baseline
You may not qualify if…
- Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
- Receipt of any pharmacotherapy for sleep or AUD in the past 30 days
- Current DSM-5 diagnosis of sever substance use disorder that is not currently being treated, other than nicotine
- Suicide attempt in the last 2 years
- Moderate hepatic impairment indicating an inability to receive the full dose of 50mg/day
- History of narcolepsy or complex sleep behaviors with sedative-hypnotics
- Any other medical (discernible by initial blood test) or psychiatric condition that our medical team determines would compromise safe participation
Where it is running
- WSU Research Clinic — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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