Daridorexant for People With Insomnia and Alcohol Use Disorder Study (NCT07701928) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Daridorexant for People With Insomnia and Alcohol Use Disorder Study
United States205 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Exclusion Criteria:
* 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 tea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-Reported Drinks Per Day and Heavy Drinking Days
Timeframe: From enrollment to end of treatment at 12 weeks, and follow-up at 1-month, 6-months, and 1-year post treatment.
2
Biochemically Verified Alcohol Use and Heavy Drinking Days
Timeframe: From enrollment to end of treatment at 12 weeks, and follow-up at 1-month, 6-months, and 1-year post treatment.