NMDA and Sigma-1 combination therapy for smoking cessation with AXS-05

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind study that compares AXS-05 to placebo and to bupropion over 12 weeks, followed by an 18-week observation period. Participants are assigned in a 1:1:1 ratio and will be monitored for safety and quitting outcomes. The trial aims to determine if the AXS-05 combination improves cessation rates and tolerability in adults who smoke. The study uses a parallel-group design with active and placebo controls to provide robust efficacy data. Locations include sites in Phoenix, Little Rock, and Lemon Grove.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 18 to 65 (inclusive)

Exclusion Criteria:

* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Where it's running

• Clinical Research Site
  Phoenix, Arizona, United States Recruiting
• Clinical Research Site
  Little Rock, Arkansas, United States Recruiting
• Clinical Research Site
  Lemon Grove, California, United States Recruiting
• Clinical Research Site
  Long Beach, California, United States Recruiting
• Clinical Research Site
  Pomona, California, United States Recruiting
• Clinical Research Site
  DeLand, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: AXS-05-SC-301@axsome.com
• Phone: 212-332-5061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.