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

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.

Key facts

Study ID

NCT02044874

Run by

Arena Pharmaceuticals

People needed

603

Starts

2014-03-01

Expected to finish

2014-11-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pharmacology Research Institute — Encino, California, United States
• Synergy Escondido — Escondido, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Desert Valley Research — Rancho Mirage, California, United States
• Avail Clinical Research — DeLand, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Compass Research East — Leesburg, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Compass Research — Orlando, Florida, United States
• Compass Research East — Oviedo, Florida, United States
• Meridien Research — Tampa, Florida, United States
• iResearch Atlanta — Decatur, Georgia, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Quality Clinical Research Inc. — Omaha, Nebraska, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Integrative Clinical Trials — Brooklyn, New York, United States
• Duke University — Durham, North Carolina, United States
• PMG Research Inc. — Raleigh, North Carolina, United States
• PMG Research Inc. — Wilmington, North Carolina, United States
• PMG Research Inc. — Winston-Salem, North Carolina, United States
• Neurobehavioral Clinical Research — Canton, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Clinical Trial Center — Jenkintown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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