Daridorexant for People With Insomnia and Alcohol Use Disorder Study
Key facts
- Who runs it
- Sterling McPherson
- Where
- Spokane, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 205 people, planned
- Started
- 1 Sept 2026
- Expected to end
- Dec 2031
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Daridorexant
- Placebo
- Brief Counseling
- MEMS and Medication Accounting
- Contingency Management for Medication Adherence
- Record updated
- 14 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Current DSM-5 diagnosis of sever substance use disorder that is not currently being treated, other than nicotine
- 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
- Receipt of any pharmacotherapy for sleep or AUD in the past 30 days
- Suicide attempt in the last 2 years
Where in United States
- WSU Research ClinicSpokane, United StatesContact: Research CoordinatorNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- PlaceboPlacebo, for comparison
Treatment: Placebo, Brief Counseling, MEMS and Medication Accounting, and Contingency Management for Medication Adherence
- DaridorexantTreatment being tested
Treatment: Daridorexant, Brief Counseling, MEMS and Medication Accounting, and Contingency Management for Medication Adherence
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Daridorexant for the Treatment of Sleep Amongst Those With Alcohol Use Disorder Using the Addiction Neuroclinical Assessment Framework
- Record updated
- 14 July 2026