Expired Study
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Clinical Trial 9706

Winston Salem, NC 27103


Study Summary:

The purpose of this study is to find out how an anti-nicotine vaccine changes the way your body processes nicotine from cigarettes. The vaccine produces antibodies that absorb nicotine in your blood and reduce nicotine levels in your brain, which may help you quit smoking.

This study consists of one physical screen and 14 study sessions over a 25-26 week period. The physical exam will take approximately 2½-3 hours and includes a drug screen. If you test positive for illegal drugs you will not be eligible to participate. A blood sample will be taken to check your general health, to test for HIV and for DNA analysis. If you test positive for HIV you will not be eligible to participate. If you qualify to participate, the study sessions will involve the following types of visits: Smoking Evaluation Sessions, Positron Emission Tomography (PET) Sessions and Vaccine Sessions.

There will be 8 Smoking Evaluation Sessions; the first one lasting approximately 90 minutes, and 7 other sessions lasting approximately 45-60 minutes each. During these sessions, your blood pressure, heart rate and the CO in your exhaled breath will be measured. Blood samples will be taken to measure the amount of nicotine in your blood and check your health status. You will also be asked to fill out questionnaires.

There will also be 2 Positron Emission Tomography (PET) Sessions; each lasting approximately 6 to 8 hours. PET scans are used to show chemical and functional changes within your body. During these scans, you will be asked to lie on an imaging table and remain still while the images are being taken. Blood samples will be taken to measure the amount of nicotine in your blood and to test for antibodies resulting from the vaccination. Your blood pressure, heart rate and the CO in your exhaled breath will also be measured. These sessions will take place at the Research PET Center at the Wake Forest School of Medicine.

Finally there will be 4 Vaccination Sessions; the first one lasting approximately 2 hours, and 3 other sessions lasting approximately 1.5 hours each. During these sessions, you will be randomly assigned to receive either the anti-nicotine vaccination or a placebo vaccination. This assignment will be made by chance, like drawing numbers from a hat.


Qualified Participants May Receive:

For your participation, you will be compensated up to $1200. If you complete all study sessions and requirements, you will receive an additional $300. You will not be compensated for the physical screening.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.