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

Testing AXS-05's impact on adult smoking cessation safety and effectiveness.

Recruiting
18-65 years
All
Phase 3

This study aims to find out how well a new treatment called AXS-05 helps adults stop smoking. It compares AXS-05 to a placebo (a pill that looks like the real medicine but has no active ingredients) and another medicine called bupropion, which is already used to help people quit smoking. The study is Phase 3, meaning it is in the later stages of testing, and it involves many participants across different locations. Participants will be randomly assigned to receive either AXS-05, bupropion, or placebo for 12 weeks, and will be followed for an additional 18 weeks after treatment. To join, you must be between the ages of 18 and 65 and able to follow the study rules. You cannot join if the study doctor thinks it's not safe for you.

  • The study lasts for about 30 weeks in total.
  • Participants will visit the study site for check-ups and monitoring.
  • There may be risks or side effects, similar to other medicines.
Study details
    Smoking Cessation

NCT07766655

Axsome Therapeutics, Inc.

11 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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