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Clinical trial

A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

NCT07766655 is registered in ClinicalTrials.gov with Axsome Therapeutics, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
Lead sponsor
Axsome Therapeutics, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
August 27, 2026
Completion date
December 31, 2027
Enrollment
705 (estimated)
Sites
26

Conditions

As the registry lists them; a condition with its own page is linked.

smoking cessation