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Taking people in United StatesPhase 3

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

Key facts

Who runs it
Axsome Therapeutics, Inc.
Where
Austin, Brooklyn, Columbus, Dallas, DeLand, Duncansville, Evansville, Fort Worth, Huston, Jacksonville, Kansas City, Knoxville, Lemon Grove, Little Rock, Long Beach, Memphis, Mount Airy, Nashville, Newport News, North Charleston, Orlando, Phoenix, Pomona, Rochester, Skokie, Stockbridge, and Tampa, United StatesSee the 27 sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
705 people, planned
Started
27 Aug 2026
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • AXS-05 (dextromethorphan-bupropion)
  • Bupropion
  • Placebo
Record updated
6 November 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • Austin, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Brooklyn, New YorkHospital not named in the registryContact: Study DirectorTaking people
  • Columbus, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Dallas, TexasHospital not named in the registryContact: Study DirectorTaking people
  • DeLand, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Duncansville, PennsylvaniaHospital not named in the registryContact: Study DirectorTaking people
  • Evansville, IndianaHospital not named in the registryContact: Study DirectorTaking people
  • Fort Worth, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Huston, TexasHospital not named in the registryContact: Study DirectorTaking people
  • Jacksonville, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Kansas City, KansasHospital not named in the registryContact: Study DirectorTaking people
  • Knoxville, TennesseeHospital not named in the registryContact: Study DirectorTaking people
  • Lemon Grove, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Little Rock, ArkansasHospital not named in the registryContact: Study DirectorTaking people
  • Long Beach, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Memphis, TennesseeHospital not named in the registryContact: Study DirectorTaking people
  • Mount Airy, North CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Nashville, TennesseeHospital not named in the registryContact: Study DirectorTaking people
  • Newport News, VirginiaHospital not named in the registryContact: Study DirectorTaking people
  • North Charleston, South CarolinaHospital not named in the registryContact: Study DirectorTaking people
  • Orlando, FloridaHospital not named in the registryContact: Study DirectorTaking people
  • Phoenix, ArizonaHospital not named in the registryContact: Study DirectorTaking people
  • Pomona, CaliforniaHospital not named in the registryContact: Study DirectorTaking people
  • Rochester, New YorkHospital not named in the registryContact: Study DirectorTaking people
  • Skokie, IllinoisHospital not named in the registryContact: Study DirectorTaking people
  • Stockbridge, GeorgiaHospital not named in the registryContact: Study DirectorTaking people
  • Tampa, FloridaHospital not named in the registryContact: Study DirectorTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • AXS-05Treatment being tested

    Up to 12 weeks

    Treatment: AXS-05 (dextromethorphan-bupropion)

  • BupropionTreatment being tested

    Up to 12 weeks

  • PlaceboPlacebo, for comparison

    Up to 12 weeks

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Fit questions
Built from NCT07766655, who can take part
Record updated
6 November 2026