Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
ConditionSmoking Cessation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Male or female, aged 18 to 65 (inclusive)
Disqualifiers
Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
AXS-05 (dextromethorphan-bupropion)
DrugAXS-05 tablets, taken twice daily for 12 weeks.
Bupropion
DrugBupropion tablets, taken twice daily for 12 weeks.
Placebo
DrugPlacebo tablets, taken twice daily for 12 weeks.
Treatment groups
705 Participants
are divided into 3 treatment groupsGroup A: AXS-05Experimental treatment 1 intervention
Group B: BupropionExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
4-Week Continuous Smoking Abstinence Rate
Time frame
Weeks 9 to 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov