A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
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.
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
- Enrollment
- 705 participants
Conditions and interventions
Conditions
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
- Jul 31, 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
- Last update posted
- Aug 13, 2026
2026 – 2027
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Little Rock | Arkansas | 772211 | Recruiting |
| Clinical Research Site | Jacksonville | Florida | 32256 | Recruiting |
| Clinical Research Site | Orlando | Florida | 32801 | Recruiting |
| Clinical Research Site | Stockbridge | Georgia | 30281 | Recruiting |
| Clinical Research Site | Kansas City | Missouri | 64114 | Recruiting |
| Clinical Research Site | Brooklyn | New York | 11235 | Recruiting |
| Clinical Research Site | Knoxville | Tennessee | 37909 | Recruiting |
| Clinical Research Site | Memphis | Tennessee | 38119 | 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.
Recently updated Smoking Cessation trials
Other public records listing Smoking Cessation. Sorted by last update posted; newest first. Not a recommendation.
- NCT07789496: Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation Not yet recruiting
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- NCT07166120: Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients Recruiting
- NCT07602699: Multi-Site Trial of Tirzepatide for Smoking Cessation Recruiting
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 Aug 13, 2026 · Synced Aug 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07766655 live on ClinicalTrials.gov.