Daridorexant for Sleep and Smoking Cessation
This study is looking at how a medication called daridorexant (50 mg) affects sleep, daytime alertness, and smoking habits in people who smoke and have trouble sleeping. The goal is to see if improving sleep can help people reduce or stop smoking. You might be able to join if you are between 18 and 55 years old, smoke more than 10 cigarettes a day, and have been smoking for at least a year. You also need to be willing to try to cut back or stop using tobacco products during the study. Researchers will measure your sleep quality, how alert you are during the day, and your insomnia (trouble sleeping) severity to see if daridorexant is helpful. The study plans to include 44 participants, but its current status is unclear.
- Study design
- This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either daridorexant or a placebo (an inactive substance) without knowing which they are getting. It plans to enroll 44 participants.
- What's involved
- You will take daridorexant or a placebo daily for three weeks. Your sleep will be monitored with a device and diary, and your daytime alertness will be tested three times a week. You will also complete questionnaires about smoking, craving, withdrawal, sleepiness, and mood.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sleep quality will be assessed for 3 weeks, and daytime alertness will be assessed for 3 weeks. Insomnia severity will be assessed at the end of the 3-week study period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Sleep Quality2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration.
Sleep device to assess: latency to sleep, number of awakenings during the night, and sleep stages.
- Daytime alertnessAssessed 3 times per day (morning, midday, evening), 3 times per week for 3 weeks.
Assess daytime alertness using a 5 min psychomotor vigilance task. Higher score indicates lower alertness.
- Insomnia Severity IndexAssess at prescreening and on last day of the study (3 weeks and 2 days)
Assesses extent of insomnia. Range is 0-28. Higher score indicates high level of insomnia.
- Sleep Quality-sleep diaryAssessed 2 days prior to taking daridorexant and daily for 3 weeks during daily daridorexant administration.
Daily sleep diary to assess self-reported sleep
- Pittsburgh Sleep Quality Index2 days before beginning study medication.
Assesses sleep quality (duration, disturbance, latency) over last 1 month. Range is 0-21; higher score indicates worse sleep quality.
- PROMIS Sleep-Short Form 8a2 days before beginning study medication and last day of weeks 1, 2, 3.
Assesses sleep quality over last 7 days. Range is 8-40, higher score indicates worse sleep/low alertness.
- Karolinska Sleepiness ScaleGiven 3X/day on days 3, 5, 7 of weeks 1, 2, 3.
Assesses daytime alertness - single question. Range is 1-10. Higher score indicates lower alertness.