Daridorexant for Alcohol Use Disorder

Johns Hopkins University

Status and phase: Begins enrollment in 7 months; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Other: Placebo; Drug: Daridorexant 50 mg

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07532252

IRB00492313

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Daridorexant

Experimental group

Description:

Daridorexant 50mg (Oral)

Treatment:

Drug: Daridorexant 50 mg

Placebo

Placebo Comparator group

Description:

Placebo (Oral)

Treatment:

Other: Placebo