Daridorexant for Smoking
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether daridorexant, originally approved for treating insomnia, can aid smokers in quitting by improving sleep quality. Many smokers struggle to remain smoke-free because quitting often disrupts sleep, leading to relapse. Daridorexant may help by blocking orexin, a brain chemical linked to wakefulness, potentially reducing the urge to smoke by enhancing sleep. Participants should be smokers of at least 10 cigarettes a day for over a year and willing to try quitting while monitoring their sleep. As a Phase 4 trial, daridorexant is already FDA-approved and proven effective, and this research aims to understand how it can benefit more patients.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications if you want to participate in this trial. Specifically, you cannot be on any drugs for smoking cessation, insomnia, ADHD, anti-seizure medications, or certain other medications that interact with daridorexant. It's best to discuss your current medications with the study doctor to see if you qualify.
What is the safety track record for daridorexant?
Research has shown that daridorexant is generally safe and well-tolerated. In earlier studies, patients experienced improved sleep without serious side effects. Reported side effects were mild, with some individuals feeling drowsy, but this sensation quickly subsided. The FDA approved daridorexant for treating insomnia, indicating its safety for that purpose. It has not shown signs of being addictive or causing withdrawal symptoms, making dependency less likely. Although daridorexant hasn't been specifically tested in smokers, its safety in other groups appears promising.12345
Why are researchers enthusiastic about this study treatment?
Daridorexant is unique because it tackles smoking cessation through a new mechanism of action. While most smoking cessation aids, like nicotine patches or medications such as varenicline, focus on nicotine replacement or modulating dopamine pathways, daridorexant acts as an orexin receptor antagonist. This means it targets the brain's wakefulness and arousal systems, potentially reducing the urge to smoke and easing withdrawal symptoms. Researchers are excited about daridorexant because it opens up a novel pathway for treating nicotine addiction, potentially offering an alternative for those who haven't succeeded with existing options.
What is the effectiveness track record for daridorexant in treating insomnia in smokers?
Research shows that daridorexant, a drug for insomnia, might also help people quit smoking. In earlier studies, daridorexant improved sleep quality, which is crucial because poor sleep can lead to relapse. Many smokers struggle with sleep, especially when quitting, and better sleep can aid their success. This trial will give participants either daridorexant or no treatment to assess its effectiveness in aiding smoking cessation. Daridorexant helps people stay alert during the day without causing grogginess, unlike some other sleep aids. By improving sleep, daridorexant might reduce the urge to smoke, making it a promising option for those trying to quit.12345
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
Citations
Impact of Daridorexant on Sleep, Daytime Alertness, and ...
Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, ...
A Preliminary Report on the Effects of Daridorexant in Patients ...
All sleep outcomes significantly improved throughout treatment, which was generally safe and well tolerated, with mild and transient drowsiness ...
Daridorexant for Smoking · Info for Participants
Blockers of orexin have recently been proposed as a promising therapy for smoking cessation. Insomnia has been reported in up to 40% of smokers, ...
214985Orig1s000 - accessdata.fda.gov
Results of Efficacy Analyses, Trial ID-078A301 ... available data on daridorexant use in pregnant women. A postmarketing requirement ...
Daridorexant prescribing information sheet
Good sleep hygiene should be established. Other strategies that may aid sleep should also be encouraged, eg. mindfulness, smoking cessation, exercise, reducing ...
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