AXS-05 Phase II Trial on Smoking Behavior

• Status: Completed
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James Davis
• Collaborator: Axsome Therapeutics, Inc.
• Treatments: Bupropion; Dextromethorphan; Nicotine

Criteria

Key Inclusion Criteria:

1. Age 18 years or above

2. Daily smoker using 10 or more cigarettes per day

3. Willing to be smoke-free for 7 days

4. Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements.

5. 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:

1. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion)

2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)

3. Not pregnant or breastfeeding

4. Contraindication to the use of bupropion.

5. Additional criteria may apply.