Daridorexant for Alcohol Use Disorder

Sponsor
Johns Hopkins University
Study ID
NCT07532252
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 50 mg — DRUG
    Daridorexant 50 mg (Orally administered)
  • Placebo — OTHER
    Placebo (Oral)

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Apr 2026
Primary completion
Aug 1, 2030
Completion
Feb 1, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daridorexant
    Daridorexant 50mg (Oral)
  • Placebo Comparator: Placebo
    Placebo (Oral)

Primary Outcome Measure

Total Sleep Time (Minutes) [ Time Frame: Enrollment to one month follow-up ]

Central Contacts

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