Project Grant R01AA031981

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) awarded The Johns Hopkins University a $616,371 Project Grant on June 10, 2026, under the Alcohol Research Programs (CFDA 93.273) to conduct a double-blind, randomized controlled clinical trial evaluating daridorexant as a treatment for alcohol use disorder (AUD) with co-occurring sleep disturbance. The primary deliverables include the execution of a rigorous clinical trial comparing daridorexant, a dual orexin receptor antagonist (DORA), against placebo in reducing alcohol craving and use while improving sleep quality among patients with AUD. The study integrates the trial into a real-world treatment setting, recruiting participants from a residential treatment facility following medically managed withdrawal and conducting comprehensive assessments of alcohol craving, total sleep time (via wireless electroencephalography and biometric data), and adverse events.

The research protocol extends through May 31, 2031, and includes post-discharge follow-up monitoring for two weeks with daily self-reported alcohol use and craving data, three-times-weekly breath alcohol level testing, and weekly check-in visits to assess safety and confirm adherence. A one-month follow-up assessment will evaluate long-term outcomes on alcohol use, AUD symptoms, and sleep quality. This study is designed to establish clinical evidence supporting daridorexant as a novel pharmacological intervention for the co-occurring conditions of AUD and sleep disturbance, contributing to the evidence base for improved treatment methods in alcohol-related disorders as mandated by NIAAA's research mission.