A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:
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
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