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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07766655

Public ClinicalTrials.gov record NCT07766655. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 16, 2026, 5:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07766655
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
705 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 27, 2026 (Actual)
Primary completion
Dec 2027 (Estimated)
Completion
Dec 2027 (Estimated)
Last update posted
Oct 13, 2026

2026 – 2027

United States locations

U.S. sites
26
U.S. states
13
U.S. cities
25
Facility City State ZIP Site status
Clinical Research Site Little Rock Arkansas 72211 Recruiting
Clinical Research Site Lemon Grove California 91945 Recruiting
Clinical Research Site Long Beach California 90806 Recruiting
Clinical Research Site Pomona California 91767 Recruiting
Clinical Research Site DeLand Florida 32720 Recruiting
Clinical Research Site Jacksonville Florida 32256 Recruiting
Clinical Research Site Orlando Florida 32801 Recruiting
Clinical Research Site Tampa Florida 33614 Recruiting
Clinical Research Site Columbus Georgia 31901 Recruiting
Clinical Research Site Stockbridge Georgia 30281 Recruiting
Clinical Research Site Skokie Illinois 60077 Recruiting
Clinical Research Site Evansville Indiana 47714 Recruiting
Clinical Research Site Kansas City Missouri 64114 Recruiting
Clinical Research Site Brooklyn New York 11229 Recruiting
Clinical Research Site Brooklyn New York 11235 Recruiting
Clinical Research Site Rochester New York 14609 Recruiting
Clinical Research Site Duncansville Pennsylvania 16635 Recruiting
Clinical Research Site North Charleston South Carolina 29405 Recruiting
Clinical Research Site Knoxville Tennessee 37909 Recruiting
Clinical Research Site Memphis Tennessee 38119 Recruiting
Clinical Research Site Nashville Tennessee 37203 Recruiting
Clinical Research Site Austin Texas 78705 Recruiting
Clinical Research Site Dallas Texas 75251 Recruiting
Clinical Research Site Fort Worth Texas 76135 Recruiting
Clinical Research Site Huston Texas 77061 Recruiting
Clinical Research Site Newport News Virginia 23606 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07766655, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2026 · Synced Oct 16, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07766655 live on ClinicalTrials.gov.

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