Alcohol Use DisorderPhase 2NCT07532252
Daridorexant for Alcohol Use Disorder
A Phase 2 study testing Daridorexant 50 mg in people with Alcohol Use Disorder, run by Johns Hopkins University.
Trial summary
This study will test whether the dual orexin receptor antagonist (DORA) daridorexant reduces alcohol craving and use and improves total sleep time among patients with co-occurring alcohol use disorder and sleep disturbance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Daridorexant 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Feb 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-Blind Randomized Controlled Trial of Daridorexant for Alcohol Use Disorder
This study will test whether the dual orexin receptor antagonist (DORA) daridorexant reduces alcohol craving and use and improves total sleep time among patients with co-occurring alcohol use disorder and sleep disturbance. The study will assess the role of the orexin system in modulating alcohol craving and use in a real-world treatment setting.
- Conditions
- Alcohol Use Disorder
- Being tested
- Daridorexant 50 mg, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 50 mgDrug
Daridorexant 50 mg (Orally administered)
PlaceboOther
Placebo (Oral)
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant | Experimental | Daridorexant 50mg (Oral) Receives: Drug: Daridorexant 50 mg |
| Placebo | Placebo comparator | Placebo (Oral) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (Minutes)
Total sleep time will be assessed through both wireless EEG and ambulatory monitoring. Wireless EEG will be assessed during the residential phase only. Ambulatory monitoring will occur during both the residential and outpatient phase.
Measured: Enrollment to one month follow-up
Alcohol Craving Visual Analogue Scale
Visual Analogue Scales assessing alcohol craving will be administered (Range 0-100, higher scores indicate greater craving).
Measured: Enrollment to one month follow-up
Daily alcohol use, assessed via Timeline Followback (TLFB)
Measured: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Adverse Events
Measured: From enrollment to one month follow-up
Secondary outcomes (4)
Daily binge drinking, assessed via Timeline Followback (TLFB)
Measured: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Participants with Positive breathalyzer screen
Measured: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Alcohol use disorder symptoms
Alcohol use disorder symptoms, assessed using the Alcohol Use Disorders module of the Mini-International Neuropsychiatric Interview. 9-items rated on a dichotomous Yes/No scale.
Measured: Enrollment to one-month follow-up
Self-Reported Insomnia Severity
Self-reported insomnia severity, assessed using the Insomnia Severity Index. Each item is scored 0 (no problem) - 4 (very big problem) likert scale with total score range between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Enrollment to one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Idorsia Pharmaceuticals Ltd., National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jennifer Ellis, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532252
- Sponsor's protocol ID
- IRB00492313
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared via the NIAAA Data Archive following publication. Access will be controlled and require submission of a Data Access Request. Supporting documentation will also be provided.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Controlled Trial of Daridorexant for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07532252
- Acronym / sponsor ID
- IRB00492313
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Idorsia Pharmaceuticals Ltd., National Institutes of Health (NIH)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether the dual orexin receptor antagonist (DORA) daridorexant reduces alcohol craving and use and improves total sleep time among patients with co-occurring alcohol use disorder and sleep disturbance. The study will assess the role of the orexin system in modulating alcohol craving and use in a real-world treatment setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daridorexant | Experimental | Drug: Daridorexant 50 mgDaridorexant 50mg (Oral) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (Oral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant 50 mgDaridorexant 50 mg (Orally administered) | Drug | Daridorexant |
| PlaceboPlacebo (Oral) | Other | Placebo |
Primary outcome
Total Sleep Time (Minutes)
Time frame: Enrollment to one month follow-up
Total sleep time will be assessed through both wireless EEG and ambulatory monitoring. Wireless EEG will be assessed during the residential phase only. Ambulatory monitoring will occur during both the residential and outpatient phase.
Alcohol Craving Visual Analogue Scale
Time frame: Enrollment to one month follow-up
Visual Analogue Scales assessing alcohol craving will be administered (Range 0-100, higher scores indicate greater craving).
Daily alcohol use, assessed via Timeline Followback (TLFB)
Time frame: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Adverse Events
Time frame: From enrollment to one month follow-up
4 secondary outcomes
Daily binge drinking, assessed via Timeline Followback (TLFB)
Time frame: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Participants with Positive breathalyzer screen
Time frame: Outpatient phase (Day 1 post-residential treatment to one-month follow-up)
Number of Alcohol use disorder symptoms
Time frame: Enrollment to one-month follow-up
Self-Reported Insomnia Severity
Time frame: Enrollment to one-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared via the NIAAA Data Archive following publication. Access will be controlled and require submission of a Data Access Request. Supporting documentation will also be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Ellis principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daridorexant 50 mg in people with Alcohol Use Disorder, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ellis (410-550-6346, jellis36@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (Minutes) (time frame: Enrollment to one month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.