NCT07766655 Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
| NCT ID | NCT07766655 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Axsome Therapeutics, Inc. |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 705 participants |
| Start Date | 2026-08-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 705 participants in total. It began in 2026-08-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07766655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07766655 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 705 participants.
Is NCT07766655 currently recruiting?
Yes, NCT07766655 is actively recruiting participants. Contact the research team at AXS-05-SC-301@axsome.com for enrollment information.
Where is the NCT07766655 trial being conducted?
This trial is being conducted at Little Rock, United States, Lemon Grove, United States, Pomona, United States, DeLand, United States and 11 additional locations.
Who is sponsoring the NCT07766655 clinical trial?
NCT07766655 is sponsored by Axsome Therapeutics, Inc.. The trial plans to enroll 705 participants.