Daridorexant for Insomnia and Alcoholism
(DIAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults who have both insomnia and alcohol use disorder. Participants should be willing to take medication, attend regular study visits, provide biological samples, and complete surveys about their sleep and drinking habits.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Daridorexant
Trial Overview
The study compares the effects of daridorexant (a sleep medication) versus a placebo on reducing alcohol use and improving sleep in people with insomnia and alcohol use disorder. All participants also receive brief counseling and support to help them stick to taking their medication.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sterling McPherson
Lead Sponsor
University of Kentucky
Collaborator
University of Mississippi Medical Center
Collaborator
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