Daridorexant for Alcohol Use Disorder

NCT07532252 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00492313
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. The study will assess the role of the orexin system in modulating alcohol craving and use in a real-world treatment setting.

Conditions

Daridorexant; Placebo - Control

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  Enrollment to one month follow-up

• Daily alcohol use, assessed via Timeline Followback (TLFB)

  Outpatient phase (Day 1 post-residential treatment to one-month follow-up)

• Number of Adverse Events

  From enrollment to one month follow-up

Secondary Outcomes (4)

• Daily binge drinking, assessed via Timeline Followback (TLFB)

  Outpatient phase (Day 1 post-residential treatment to one-month follow-up)

• Number of Participants with Positive breathalyzer screen

  Outpatient phase (Day 1 post-residential treatment to one-month follow-up)

• Number of Alcohol use disorder symptoms

  Enrollment to one-month follow-up

• Self-Reported Insomnia Severity

  Enrollment to one-month follow-up

Study Arms (2)

Daridorexant

EXPERIMENTAL

Daridorexant 50mg (Oral)

Drug: Daridorexant 50 mg

Placebo

PLACEBO COMPARATOR

Placebo (Oral)

Other: Placebo

Interventions

Placebo OTHER

Placebo (Oral)

Placebo

Daridorexant 50 mg DRUG

Daridorexant 50 mg (Orally administered)

Daridorexant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Idorsia Pharmaceuticals Ltd.: collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Interventions

daridorexant

Study Officials

• Jennifer Ellis

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Ellis

CONTACT

410-550-6346; jellis36@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): February 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF