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The purpose of this study is to find out whether smokers should be switched to a different study drug (Chantix alone or Chantix paired with Zyban) based on their initial response to nicotine patches. This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.
This study consists of one physical screen and seven study sessions over a 13-week period. You may also be asked to come in for a follow-up session six months after your quit day. The physical exam will take approximately 2-2 ½ hours and includes a drug screen. If you test positive for illegal drugs, you will not be eligible to participate. The first study session will last approximately 1-1½ hours, and all other sessions will last approximately 45 minutes to 1 hour. All of the seven study sessions will take place between 12PM-4PM Monday through Friday. If you complete all sessions and study requirements you will be compensated up to $280. You will receive a check in the mail after you complete study participation. Please allow four to six weeks for your payment to be processed. Subjects who qualify and come back in for a follow up session six months after their quit day, will receive an additional $50 check in the mail.
If the physical screen confirms you are a good match for this study, we will ask you to come in for your first study session about one week later. At this time you will be asked to set your quit smoking date, which will occur 2 weeks later. During the early part of the study some participants will be randomly assigned to receive Chantix alone, or Chantix paired with Zyban, based on their initial responses to the patches. After the quit smoking date participants still receiving nicotine patches may be randomly assigned to receive the a Nicotrol Inhaler to use in addition to the nicotine patches. Both of these assignments will be made randomly, like flipping a coin.
During all study sessions we will be measuring the carbon monoxide in your breath, collecting a saliva sample and taking your heart rate, blood pressure and weight. You will also be asked to fill out questionnaires. Enough study medication will be given to you to last until your next session.
(IRB#27351)
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