Clinical Trial

Targeting Orexin to Treat Nicotine Dependence

Active, Not Recruiting Phase 1
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Record status
This record was last updated July 14, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Tobacco smoking continues to be the primary cause of preventable mortality in the United States. Despite the availability of smoking cessation aids, the majority of those trying to quit smoking end up relapsing. Thus, there is a strong need to evaluate alternative treatment targets such as orexin antagonists, which have shown promise in preclinical models at reducing the motivational aspects of drug use.The current work will evaluate the influence of orexin antagonism on several factors impacting the motivation to smoke.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-06-25; most recent amendment 2026-07-13.
Status change: Recruiting → Active, Not Recruiting 2026-07-13
Status change: Not Yet Recruiting → Recruiting 2020-02-19
Trial Details
NCT Number NCT03999099
Lead Sponsor Mclean Hospital
Conditions Nicotine Dependence
Enrollment 45 participants
Start Date 2019-09-26
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-14