UCLA IRB #15-000950

Thank you for your interest in our Smoking Cessation Study. First, we would like to tell you some information about the research study and what your involvement would include. Then we will ask you some questions to determine if you are eligible for this study.

The purpose of this study is to see if smokers who drink alcohol regularly are able to quit smoking successfully when taking a combination of 2 medications, Varenicline (also known as Chantix) and Naltrexone. Varenicline is an FDA approved smoking cessation medication, and naltrexone is an FDA approved treatment for alcohol dependence. The study consists of an in-person screening and physical exam, a 14 week treatment period, brief smoking cessation counseling, and follow up visits.

During your first visit, you will sign a consent form, be asked to provide a urine sample, blow into a breathalyzer and carbon monoxide (CO) monitor to check for recent alcohol or drug use and verify that you are a smoker. (If you are unable to produce a 0.000 on the breathalyzer, show valid identification, if you test positive on the urine drug screen for any drugs other than marijuana, or if you test positive on the pregnancy test, we will NOT run your visit and you will NOT be compensated; however, you may have the opportunity to reschedule.) You will also complete a series of questionnaires and interviews. If you are eligible after the first visit, you will be scheduled for a physical exam with the study physician. The study physician will review your medical history and you will have blood drawn for laboratory tests, in addition to an EKG to see if you are healthy enough to take the study medication. Each of these visits will take 2 hours or less and you will be compensated $20 for your time.

If you are eligible, you will be scheduled for a physical exam visit with the study physician. The study physician will review your medical history and you will have blood drawn for laboratory tests, in addition to an EKG to look at your heart function. This visit will help determine if you are healthy enough to take the study medication. It will take 1.5-2 hours and you will be compensated $20 for your time.

If you are eligible to participate, you will be randomly assigned to one of two medication groups. You will be given the smoking cessation medication, varenicline (Chantix), plus either naltrexone or placebo (which is a sugar pill). You will be asked to attend a counseling session and then quit smoking 2 weeks after starting the study medication. You will be on the study medication for a total of 14 weeks and will be asked to complete 8 follow up visits over 6 months.  The follow up sessions will last 1 hour or less and will involve blowing into a breathalyzer and CO monitor, providing a urine sample, brief counseling sessions and questionnaires about your drinking and smoking. You will be compensated for each visit, adding up to a total of $370 if you complete the entire study. You will also be provided with parking validation or bus tokens to each study visit.
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