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Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation - Durham NC (Clinical Trial 11565)

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City: Durham
State: NC
Zip Code: 27705
Study summary: The purpose of this study is to look at brain function and attempt to predict which study drug or combination (nicotine patches, Chantix alone, or Chantix paired with Zyban) will be successful in helping individual smokers quit smoking.

This study consists of one physical screen, one fMRI training session, two fMRI scanning sessions, 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 fMRI training session will last approximately one hour, and the two fMRI scanning sessions will take approximately 1½ hours each. Each of the seven study sessions will last approximately 30 minutes.

If the physical screen confirms you are a good match for this study, we will ask you to come in for your fMRI training session as soon as possible. During the training session you will be familiarized with all aspects of the fMRI sessions, including tasks and equipment. The baseline fMRI scanning session will occur as soon as possible after your fMRI training session, and the first study session will occur about one week after your baseline fMRI session. During the first study session, you will be randomly assigned (like drawing numbers from a hat) to one of four groups that will determine the study drugs you will use for two weeks before your quit day.
Participants may receive: If you complete all sessions and study requirements you will be compensated up to $460. 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 for, and come back in for, a follow-up session six months after their quit day, will receive an additional $50 check in the mail. Payment for the follow-up session will be sent in a separate check four to six weeks after the session.
Study is available at: Duke Universty
2424 Erwin Road, Suite 201
Durham, NC 27705
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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 or take the Participation Quiz to find out if you are a good candidate for clinical trial participation.


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