Combining Varenicline and Bupropion for Smoking Cessation
brief summary
The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Researchers also want to learn if this drug combination can reduce cravings and other negative symptoms of nicotine withdrawal better than varenicline does alone. The safety of this drug combination will also be tested.
detailed description
The Study Drugs:
Bupropion and varenicline are designed to imitate the effects that nicotine has on the body. This may reduce cigarette cravings and help patients quit smoking.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 treatment groups.
* If you are in Group 1, you will receive varenicline and bupropion. * If you are in Group 2, you will receive varenicline and a placebo. A placebo is a substance that looks like the study drug (in this case, bupropion) but that has no active ingredients. * If you are in Group 3, you will receive a placebo that looks like varenicline and a placebo that looks like bupropion.
You will have a higher chance (5 out of 6) of receiving study drug than receiving just placebo. Equal numbers of patients will be in Groups 1 and 2. Neither you nor the study doctor will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out which study drug you are receiving.
Study Drug Administration:
You will begin taking the study drugs/placebo 1 to 10 days after the first study visit. A dose of the study drug/placebo combination will be made up of 1 tablet of varenicline or placebo and 1 tablet of bupropion or placebo. You should take each dose of study drugs/placebo with a cup (8 oz.) of water after eating a full meal.
On Days 1-3, you will take 1 dose of the study drug/placebo combination in the morning.
Beginning on Day 4, and then every day after that, you will take 1 dose in the morning and 1 dose in the evening (for a total of 2 doses of the study drug/placebo combination each day). You must return any study drug bottles as well as any unused study drug to a study staff member at each study visit.
You will be given a smoking diary to record how many cigarettes you smoke (if any) each day while you are on study. You must turn in this diary at each study visit.
Study Visits:
About 1 time each week while you are taking the study drugs/placebo, the following tests and procedures will be performed:
official title
Effectiveness of Varenicline vs. Varenicline Plus Bupropion or Placebo for Smoking Cessation