Lemborexant for Cannabis Use Disorder

Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)

The goal of this clinical trial is to investigate the use of Lemborexant as a treatment for moderate to severe Cannabis Use Disorder (CUD). The main questions it aims to answer are:

1. Is Lemborexant safe, feasible, and tolerable to use in the CUD population?
2. Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition?

Researchers will compare 10mg Lemborexant to placebo.

Participants will:

• Take 10mg Lemborexant (or placebo) nightly for 21 nights (treatment phase).
• Wear an actigraphy watch continuously for the treatment phase.
• Complete a pre-screen survey, attend an in-person screening session, 4 in-person lab visits (weekly from days 0-21), and a virtual follow-up visit 2 weeks after the treatment phase.
• Complete a short daily survey for 35 days total.

Inclusion Criteria:

• Moderate to severe Cannabis Use Disorder.
• Ability to read/write in English.

Exclusion Criteria:

• Known allergies or hypersensitivities to Lemborexant.
• Use of any Orexin-Antagonist in the past 3 months.
• Current or recent (within the past 12 weeks) participation in a clinical trial involving medication administration.
• Narcolepsy, Complex sleep behaviors, sleep apnea, restless leg syndrome, and Periodic Limb Movement Disorder.
• Currently undergoing treatment for CUD.
• Any hospitalization or emergency department visit related to cannabis use.
• Moderate to severe hepatic impairment.
• Past or ongoing moderate to severe psychiatric disorders.
• Active suicidal ideation or serious attempt within the past 3 years.
• Epilepsy or history of seizures.
• Blood pressure over 160/95mmHg at the screening session.
• Current pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study.