drugset / Trial / NCT07766655

Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)

NCT07766655 ↗

Phase 3 Recruiting 705 enrolled Axsome Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.

Timeline

Start
2026-08-27
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AXS-05 Unknown — —
Subject Bupropion Small molecule — —

Indications

No indication recorded.