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RecruitingPhase 3

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

Axsome Therapeutics, Inc. · NCT07766655

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
705
US sites recruiting
26
Study start
August 27, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AXS-05 (dextromethorphan-bupropion); Bupropion; Placebo

Conditions: Smoking Cessation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Study Director · 212-332-5061 · AXS-05-SC-301@axsome.com
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Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) (NCT07766655) | Bored Studies