Could a sleep medication curb alcohol cravings?
NCT ID NCT07532252
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether daridorexant, a drug used for insomnia, can reduce alcohol cravings and drinking while improving sleep in people with alcohol use disorder and sleep problems. About 150 adults will receive either daridorexant or a placebo for several weeks. The goal is to see if targeting the brain's orexin system can help manage alcohol use in a real-world setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- daridorexant
- What this could lead to
- If it works, this could point toward a new treatment option for alcohol use disorder that also helps with sleep problems.
- What could go wrong
- This is an early phase 2 trial with only 150 people, so results may not apply to everyone. The drug may not reduce drinking or craving as hoped, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2027
An estimate. Start dates often move.
- Expected to finish
-
Feb 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Current moderate or severe DSM-5 criteria for AUD at the time of the screening session * Evidence of clinically significant sleep disturbance, based on the Pittsburgh Sleep Quality Index (PSQI; i.e., score \>5) * Aged 18 years or older * Willingness to comply with all components of the study protocol * Use of birth control throughout the study, if a pre-menopausal female who is not sterile, and who is sexually active with a male partner or considering being sexually active with a male partner * Report ability to access a computer with an internet connection during the outpatient phase of the study to complete virtual outpatient visits * Report a desire to quit or reduce drinking (i.e., not enrolling in treatment solely to satisfy an external requirement) * Able to provide informed consent, and evidence an understanding of study procedures based on a quiz following informed consent * Fluent in English (in order to complete study assessments). Exclusion Criteria: * Current moderate or severe substance use disorder other than AUD, cannabis use disorder, nicotine use disorder, or caffeine use disorder * Pregnant or breastfeeding, or planning to become pregnant during the study * Known allergy to any DORA * Past 30-day use of any DORA * Current use of benzodiazepines or other schedule IV medications for insomnia * Use of any medications that are contraindicated for use with daridorexant * Current withdrawal symptoms, as assessed by a score \>8 on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and benzodiazepine administration in the past 24 hours * Past-year suicidal behavior * Current bipolar disorder or psychotic disorder * Abnormal liver enzyme levels (i.e., AST or ALT greater than five times above the upper limit of normal, or bilirubin greater than two times the upper limit of normal), as assessed during standard intake procedures at Ashley Addiction Treatment * AHI\>30, as assessed using a wireless EEG/apnea device, to rule out those with severe sleep apnea * Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements * Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Brain-Training games rewire the mind to fight alcohol addiction?
- Can a Stress-Hormone blocker take the edge off alcohol?
- Can MDMA plus therapy help veterans fight both PTSD and alcohol addiction?
- Brain scans probe opioid receptor imbalance in alcohol use disorder
- Spinal taps open a window on alcohol use disorder
- Can a common supplement boost female rugby performance?