AXS-05 Phase II Trial on Smoking Behavior
Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring Smoking cessation, Nicotine dependence, Bupropion, DXM, Nicotine addiction, Cigarette smoking, Dextromethorphan
Eligibility Criteria
Key Inclusion Criteria:
- Age 18 years or above
- Daily smoker using 10 or more cigarettes per day
- Willing to be smoke-free for 7 days
- Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements.
- Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.
Key Exclusion Criteria:
- Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion)
- Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)
- Not pregnant or breastfeeding
- Contraindication to the use of bupropion.
- Additional criteria may apply.
Sites / Locations
- Duke Center for Smoking Cessation
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AXS-05
Bupropion SR
Participants will receive AXS-05 (Dextromethorphan Immediate Release + Bupropion Sustained Release) for 4 weeks and will be instructed to 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.
Participants will receive Bupropion SR (Bupropion Sustained Release) for 4 weeks and will be instructed to 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.