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Targeting Orexin to Treat Nicotine Dependence

StatusCompleted
PhasePhase 1
Started2019-09-26
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Trial completed
Final enrollment: 4 participants — 9% of the 45 planned
Primary completion confirmed: July 2023 (last estimated July 2026)
2026-07-13
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-12-01→2026-07-31
Completion date2024-12-01→2026-12-31
Study sitesdetails revised at 1 of 1 site
2024-01-03
Study Status, Sponsor/Collaborators v4
Primary completion date2022-05-30→2024-12-01
Completion date2022-06-30→2024-12-01
2021-08-30
Study Status v3
Primary completion date2021-05-30→2022-05-30
Completion date2021-06-30→2022-06-30
2020-02-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-09-01→confirmed 2019-09-26
Study sites0→1
2019-08-14
Study Status v1
Start date2019-08-01→2019-09-01
2019-06-25
Original filing
Mclean Hospital
53 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT03999099
Lead Sponsor Mclean Hospital
Conditions Nicotine Dependence
Enrollment 4 participants
Start Date 2019-09-26
Primary Completion 2023-07-31 (estimated)
Study Completion 2023-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-21