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

Study acronym: SUMMIT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 9 → 16 locations Start date changed from estimate of Aug 2026 to Aug 27, 2026 · Study title shortened, about 6 wordsv2 Show 2 more changesShow less
    • Start date changed from estimate of Aug 2026 to Aug 27, 2026
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07766655
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Smoking Cessation
Enrollment 705 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov