Trial Information

Reducing Tobacco Related Health Disparities

Researchers want to learn if telephone counseling can help smokers change their smoking
patterns, when combined with other interventions.

Study Groups:

During the first (baseline) visit, you will be randomly assigned (as in a throw of the dice)
to 1 of 6 possible study groups. The first group will receive free self-help materials, and
a referral to the Quitline. The Quitline provides free quit smoking services to eligible
callers. The second group will receive free self-help materials, a referral to the Quitline,
and 300 pieces of nicotine gum at baseline. The third group will receive free self-help
materials, a referral to the Quitline, and 6 telephone counseling sessions over the next 2
years. The fourth group will receive free self-help materials, a referral to the Quitline, 6
telephone counseling sessions over the next 2 years, and 300 pieces of nicotine gum at
baseline. The fifth group will receive free self-help materials, a referral to the Quitline,
and 12 telephone counseling sessions over the next 2 years. Finally, the sixth group will
receive free self-help materials, a referral to the Quitline, 12 telephone counseling
sessions over the next 2 years, and 300 pieces of nicotine gum at baseline. All
participants, regardless of assigned group, will also receive up to 600 pieces of nicotine
gum upon request when they are ready to try to quit smoking. This is in addition to the 300
pieces of gum some participants will receive at the baseline visit.

Study Visits:

If you choose to take part in this study, you will visit M. D. Anderson up to 5 times. Your
first visit is the "baseline" visit when you enter the study. You will then be asked to
come back for 4 follow-up visits at 6, 12, 18, and 24 months after enrolling in the study.

Study Tests:

The following tests and procedures will be performed at the study visits:

- You will be asked to complete some questionnaires that will include questions about
your feelings, moods, and smoking status. These will take 60 to 90 minutes to
complete.

- You will have your height, weight, and waistline measured.

- You will complete a breath test to help estimate (guess) the amount of cigarette smoke
you inhale. The breath test uses a disposable cardboard tube that is attached to the
machine, and you blow a long, slow, steady breath into it.

- At the baseline visit and the 24-month visit only, you will have saliva samples
collected for cotinine tests. To collect the saliva, you will be asked to put a small
piece of cotton in your mouth for a few minutes. These samples will be used to measure
the amount of cotinine in your saliva. Cotinine is a chemical released in your body
when it breaks down nicotine.

All participants will be contacted by mail or telephone throughout the length of the study.
You may be contacted by mail, telephone, and/or e-mail during the study and follow-up, to be
given reminders of clinic visits. You will be asked to provide the names and contact
information for family and/or friends for the study staff to contact if the study staff has
trouble reaching you.

Genetic Testing:

As part of this study, you will be asked to provide a saliva sample that will be collected
at the first visit. To collect the saliva sample, you will be 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. The 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.

Telephone Counseling:

The telephone counseling sessions will be digitally recorded. The recordings, if not
destroyed, may be kept for use in future research studies. The recordings will be used to
help the researchers make sure that the counselors are following the correct procedures and
may be used in the future to help the investigators better understand or improve the
counseling treatment. No one but the study investigators and their staff will be allowed to
view or listen to the recordings, and the identity of the participants will be kept strictly
confidential. Your study identification number will be stated by the counselor at the
beginning of the taped session. The recordings are stored digitally, encrypted, and
password protected.

This is an investigational study. The nicotine gum used in this study is approved by the
FDA. Up to 1000 smokers will take part in this research study. All will be enrolled at M.
D. Anderson.