Reward Sensitivity and Pharmacotherapy for Smoking Cessation
brief summary
The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.
detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to Group 1 or 2.
* If you are in Group 1, you will receive varenicline and a placebo patch. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. * If you are in Group 2, you will receive an active nicotine patch and a placebo tablet.
Neither you nor the study doctor will know which group you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving (called "unblinding").
Once the study has ended and the Data Safety Monitoring Board (DSMB) at MD Anderson has granted approval, you may be unblinded at your request.
Study Drug Administration:
You will start taking your assigned study drug(s) the day after Visit 1.
You should take varenicline/placebo tablets by mouth with a cup (8 ounces) of water after eating a full meal. On Days 1-3, you will take 1 dose of the study drug each morning. Starting 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 each day). You must return any study drug bottles as well as any unused study drug to the study staff at each study visit.
You should apply the nicotine/placebo patch to the upper arm. You should put it in a slightly different place each day to avoid skin irritation. You may take the patch off at night to avoid sleeping problems.
You will be given a study diary to record how many cigarettes you smoke (if any) each day while you are on study.
You must return your study diary and any unused study drugs, patches, and/or containers at each study visit.
Study Visits (Visits 1-7):
At every study visit:
official title
The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity