At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
AXS-05 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind 4-Week Study to Evaluate the Impact of AXS-05 on Smoking Behavior
In Brief
A Phase 2 clinical trial evaluating AXS-05 and Bupropion SR for Smoking Cessation and 2 related conditions. Completed, enrolled 58 participants across 1 site.
Detailed Summary
This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation, Smoking, Cigarette, Nicotine Dependence
CountriesUnited States
CollaboratorsAxsome Therapeutics, Inc.
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartMar 2018
Primary CompletionMar 2019
TodayJul 2026
First PostedMar 21, 2018
Enrollment StartMar 25, 2018
Primary CompletionMar 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.3 years ago
Interventions
AXS-05drug
Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.
Bupropion SRdrug
Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.