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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07701928). StuddyBuddy aggregates publicly available trial information.