The purpose of the study is to test the effectiveness of an investigational drug for the prevention of relapse to smoking in men and women who have recently quit smoking. To do this, we are first conducting a 2-week phase where participants receive Nicotine Replacement Therapy and behavioral interventions. At the end of this phase, once they have quit for at least 18 hours, participants will be randomly assigned, by chance, like the flip of a coin, to receive the investigational drug (60mg/day) or placebo which looks like study drug, but contains no active medication. Participants will take the medication for a total of 6 weeks. Participants will then be asked to return for three more weekly visits after discontinuation of relapse prevention medication for follow-up.

Participants who are determined over the phone to be eligible for the study will be asked to come in to our clinic for a screening appointment. If the screen is passed, participants will return within one week for a baseline visit. Your week 1 visit will take place one week after the baseline visit. After that, participants will return within the next week for another visit where they should be smoke-free for at least 18 hours beforehand. Throughout the rest of the study, participants will come for weekly visits, which include behavioral interventions, receiving Nicotine Replacement Therapy and/or medication, and meeting with physician to monitor their progress. At each visit, participants will be asked to complete a series of questionnaires, and smoking status will be monitored. Most visits should take no more than 1 hour. At 2 of the visits, participants will be asked to use a Holter monitor, which is a device worn on the body that monitors the electrical activity of the heart 5 times during a 24 hour period.

Participants will be compensated up to $465 if all parts of the study are completed. All visits, labs, Nicotine Replacement Therapy and study medications are provided at no cost. Parking vouchers will also be provided for the MGH Fruit Street or Parkman Street garages.

Please call (617) 724-8472 or email for more information.


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