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Daridorexant for Alcohol Use Disorder

NCT07532252 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DRUG

Daridorexant 50 mg

Daridorexant 50 mg (Orally administered)

OTHER

Placebo

Placebo (Oral)

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Jennifer Ellis · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2030-08-01
Completion
2031-02-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07532252 on ClinicalTrials.gov