Lemborexant for Cannabis Use Disorder

(LemboCAN Trial)

This trial explores whether Lemborexant, a sleep aid medication, can assist individuals with moderate to severe Cannabis Use Disorder (CUD) by reducing cannabis use, improving sleep, easing withdrawal, and enhancing mental clarity. Participants will take either 10mg of Lemborexant or a placebo (a non-active pill) nightly for three weeks. This trial suits those who have struggled with heavy cannabis use and do not have certain sleep disorders or serious mental health issues. Participants will also wear a watch to monitor sleep patterns and complete short surveys. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage treatment development.

Research has shown that Lemborexant, a medication for sleep problems, is generally easy for people to take. In past studies, individuals who took up to 10 mg of Lemborexant at bedtime did not experience major issues with daily activities. It did not impair thinking or memory, nor did it cause muscle relaxation, which can be problematic with some other sleep medications.

Additionally, Lemborexant carries a low risk of addiction, reducing the likelihood of dependency. In a study examining long-term use, participants did not report any serious side effects. Most side effects were mild and temporary, such as headaches or drowsiness.

Most treatments for Cannabis Use Disorder focus on behavioral therapies and support groups, sometimes combined with medications like N-acetylcysteine or gabapentin. But Lemborexant works differently, targeting the brain's orexin system, which plays a role in regulating sleep-wake cycles and reward pathways. This unique mechanism may directly impact the cravings and withdrawal symptoms associated with cannabis use. Researchers are excited about Lemborexant because it offers a novel approach that could complement existing therapies, potentially leading to more effective and faster relief for those struggling with this disorder.

Studies have shown that Lemborexant can improve sleep, which may benefit people with Cannabis Use Disorder (CUD). Sleep problems are common in those with substance use issues, and better sleep might aid recovery. Research indicates that Lemborexant helps individuals fall asleep faster and stay asleep longer. By blocking certain brain signals that cause wakefulness, it can help manage withdrawal symptoms related to CUD. Additionally, other studies have found Lemborexant to be well-tolerated, with most side effects being mild. Its ability to promote better sleep could support its use in treating CUD. Participants in this trial will receive either Lemborexant or a placebo to evaluate its effectiveness specifically for CUD.¹⁶⁷⁸⁹