A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation

Inclusion Criteria

• Males or females aged 18-65 years, inclusive
• ≥10 cigarettes per day with no period of abstinence longer than 3 months in the past year and who are motivated to quit smoking
• Able to give signed informed consent
• Eligible female patients will be:
• non-pregnant
• non-lactating
• agree to use an acceptable method of effective contraception during the study
• Eligible male patients agree to use contraception when sexually active with a female partner who is not using an acceptable method of birth control
• Body weight of ≥50 kg (110 pounds), inclusive
• Considered to be in stable health in the opinion of the investigator

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from the study.

• Prior or current use of lorcaserin HCl
• Prior participation in any study of a nicotine vaccination
• Use of other therapies for smoking cessation is not allowed within 3 months of screening through study exit
• Use of tobacco products other than cigarettes
• Prior use of fenfluramine or dexfenfluramine
• Serious or unstable medical condition or clinically significant new illness within the 6 months prior to screening
• Previous participation in any clinical study within 6 weeks prior to the screening visit
• History of severe allergies, severe drug or excipient allergy or hypersensitivity
• History of significant cardiovascular condition
• History of other significant medical conditions
• Significant risk of suicide
• Anticipated use of any agents that are associated with valvulopathy and/or pulmonary hypertension
• Positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• Recent history of alcohol or drug/solvent abuse
• Concurrent participation in the study by more than one member of the same household
• Not suitable to participate in the study in the opinion of the investigator