Daridorexant for Smoking
What You Need to Know Before You Apply
What is the purpose of this trial?
Tobacco use is the leading cause of preventable death in the U.S., with 480,000 deaths per year and 7.7 million deaths globally. A major clinical symptom associated with abstinence from both licit and illicit drugs is insomnia, which is a clinically verified, major risk factor for relapse. Roughly half of the 40 million smokers in the U.S. attempt to quit annually, with very low rates of success. One major hurdle is poor sleep quality during abstinence. Compounding the problem is that some pharmaceuticals to help reduce smoking can increase insomnia. Poor sleep is recognized as a major impediment to maintaining abstinence from several drugs of abuse, including nicotine. Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, and 80% report regular sleep disturbances, which can be amplified during abstinence. A new orexin blocker, daridorexant, was FDA approved within the past two years for the treatment of insomnia, and while it has been tested in healthy individuals with insomnia, it has not been tested in smokers, who suffer from insomnia, particularly during the withdrawal phase when trying to quit. Daridorexant has an improved profile of beneficial effects for those with insomnia, the most notable advantage being its shorter duration of action that promotes daytime alertness, which is problematic for both active smokers and smokers during withdrawal. Poor sleep leads to daytime sleepiness, which often leads to smoking to maintain alertness.
Are You a Good Fit for This Trial?
This trial is for adult cigarette smokers aged 18-55 who smoke more than 10 cigarettes a day and have been smoking for at least a year. Participants must be willing to monitor their sleep, keep a diary, try reducing or quitting smoking, and attend three study visits. They need an iPhone (iOS 17+), can't consume grapefruit products during the study, and agree to take mobile-based tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daridorexant or placebo for 3 weeks during smoking abstinence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daridorexant
Trial Overview
The trial is testing Daridorexant, an orexin blocker recently approved for insomnia treatment. It's being compared with a placebo to see if it improves sleep quality and daytime alertness in smokers trying to quit. The goal is to determine if better sleep helps reduce relapse rates in those attempting to stop smoking.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Legacy Health System
Lead Sponsor
Washington State University
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.