Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking

Part of paid clinical trials in Portland, Oregon.

Sponsor
Legacy Health System
Study ID
NCT07328594
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 50 mg — DRUG
    Active daridorexant vs placebo comparator in smokers with insomnia
  • Placebo — OTHER
    Placebo in Smokers

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment
  • Placebo Comparator: No treatment

Primary Outcome Measure

Sleep Quality [ Time Frame: 2 days + 3 weeks study: 2 days to assess sleep prior to taking daridorexant followed by 3 weeks of daily daridorexant administration. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Legacy Research InstitutePortlandOregon97232-

Find similar trials in Portland, OR

By condition
Substance use disorderInsomnia
By specialty
Behavioral healthAddiction medicineMental healthSleep medicine
By research site
Legacy Research Institute· Portland, OR

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