Status:
COMPLETED
AXS-05 Phase II Trial on Smoking Behavior
Lead Sponsor:
James Davis
Collaborating Sponsors:
Axsome Therapeutics, Inc.
Conditions:
Smoking Cessation
Smoking, Cigarette
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This study aims to investigate the potential efficacy of a combination of two FDA-approved agents, sustained release (SR) Bupropion (BUP) and immediate release (IR) Dextromethorphan (DXM), for the pur...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03471767
Start Date
March 25 2018
End Date
March 31 2019
Last Update
December 19 2022
Active Locations (1)
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1
Duke Center for Smoking Cessation
Durham, North Carolina, United States, 27705