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NCT07701928
Daridorexant for People With Insomnia and Alcohol Use Disorder Study
Conditions: Alcohol Use Disorder, Insomnia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 205
Sponsor: Sterling McPherson
Location: WSU Research Clinic Spokane Washington
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.
Eligibility Criteria
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 team determines would compromise safe participation
Source: ClinicalTrials.gov (NCT07701928). StuddyBuddy aggregates publicly available trial information.