Trial Information

Determinants of Smoking Cessation Among Latinos

If you agree to take part in this study, you will receive treatment to help you quit
smoking, including written self-help materials, counseling, and a supply of the nicotine
patch for 4 weeks. Over the next 6 months, you will visit M. D. Anderson 5 times during
this study. You will also be called 3 times for smoking cessation counseling during this
study.

Study Visits:

First (Orientation) Visit You will be asked about your feelings and moods, as well as how
many cigarettes you smoke. You will fill out questionnaires on a computer. The
questionnaires will be about your mood, stress level, and smoking-related issues. They
should take about 1 hour and 30 minutes to complete.

You will complete a breath test. For the breath test, you will blow into a tube that's
attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.

You will give two saliva samples at this visit. To collect the first saliva sample, you will
place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check the
amount of cotinine in the body. Cotinine is a chemical that is produced in your saliva when
your body breaks down nicotine.

The second saliva sample will be collected by spitting into a container. Researchers will
perform genetic tests with these samples to look for genes that control the production and
use of neurotransmitters, naturally occurring chemical messengers in the brain. People with
certain genes may have a more difficult time quitting smoking, because of the way nicotine
affects these chemicals. Your second saliva sample will be stored in a biorepository at M.
D. Anderson for use in future research related to nicotine addiction, smoking, and/or
cancer. Your saliva sample will be placed in a bank of biological samples and data that is
available to researchers conducting research related to cancer or nicotine dependence.

Before your saliva sample can be used for research, the people doing the research must get
specific approval from the Institutional Review Board (IRB) of M. D. Anderson. The IRB is a
committee made up of doctors, researchers, and members of the community. The IRB is
responsible for protecting the participants involved in research studies and making sure all
research is done in a safe and ethical manner. All research done at M. D. Anderson,
including research involving your saliva sample from this bank, must first be approved by
the IRB.

Your samples will be given a code number. No identifying information will be directly linked
to your samples. Only the researcher in charge of the bank will have access to the code
numbers and be able to link the samples to you. Other researchers using your samples will
not be able to link this data to you.

Genetic information obtained will not be provided to you.

Second (Baseline) Visit:

Your second visit (Baseline) will occur 1 week before your Quit date visit. You will fill
out questionnaires on a computer. The questionnaires will be about your, stress level,
social support and smoking-related issues. They should take about 1 hour and 30 minutes to
complete.

You will complete a breath test. For the breath test, you will blow into a tube that's
attached to a machine that is used to estimate the amount of tobacco smoke that you inhale.

Your Height, Weight and Waist circumference measures will be taken.

You will also receive individual counseling. During counseling, you will discuss techniques
to help you quit smoking.

In addition, you will receive a small, hand-held personal computer and be trained in how to
use it. You will carry this computer with you for 4 weeks. You will use the computer to
answer questions about your mood, stress, and smoking-related issues. You will be asked to
fill out some questions on the computer each time you have an urge to smoke or you actually
smoke. Also, the computer will "beep" at random and set times and request that you answer
some questions. This computer will not wake you during the night and you will be able to
wait to answer questions for a few minutes if it goes off when you are busy. Answering the
questions should take about 5 to 10 minutes.

Third (Quit Day) and Fourth (Week 3) Study Visits:

Your Third visit (Quit Day) will occur 1 week after your Second (Baseline) visit. Your
Fourth visit will occur 3 weeks after your Quit Day. During these visits, you will be asked
to fill out questionnaires on a computer about your moods and feelings, as well as how many
cigarettes you smoke. The questionnaires should take about 30 minutes to complete.

You will also receive individual counseling. During counseling, you will discuss techniques
to help you quit smoking.

On your Third visit, you will complete the breath test and your Weight and Waist
circumference measures will also be taken.

At your Third visit you will be given a supply of nicotine patches to last until your Fourth
visit.

At your Fourth visit you will be given a one week supply of nicotine patches. You will be on
nicotine patches for a total of 4 weeks. At the Fourth Visit, you will also complete the
breath test, will give a saliva sample and your Weight and Waist circumference measures will
be taken.

Last (Week 26) Visit:

This visit will occur 26 weeks (or 6 months) after your Quit Day. During these visits, you
will be asked to fill out questionnaires on a computer about your moods and feelings, as
well as how many cigarettes you smoke.

The questionnaires should take about 1 1/2 hours to complete.

You will complete the breath test, your Weight and Waist circumference measures will be
taken and you will also give a saliva sample at the last (Week 26) visit.

Telephone Calls:

Between your first (Orientation) visit and your Fourth (Week 3) visit, you will receive 3
calls from a smoking cessation counselor. You will receive your first call a few days
before your quit day. You will receive a second call 1 week after your Quit Day and another
call 2 weeks after your Quit Day. During these calls, you will discuss techniques to help
you quit smoking. These calls will last 10 to 15 minutes and will be scheduled in advance.

Additional Information:

You may be contacted by mail, telephone, and/or e-mail throughout the study to remind you
about clinic visits. You may also be asked for information about your smoking status during
the usual reminder calls and/or calls to reschedule missed appointments.

Length of Study:

You will be considered off study when you complete the Week 26 (or Last) visit.

This is an investigational study. The nicotine patch is FDA approved and commercially
available. Up to 200 participants will take part in this study. All will be enrolled at M.
D. Anderson.