Smoking Clinical Trial
Official title:
Health Communications and Risk Processing Among Smokers
The goal of this behavioral research study is to put together and study a treatment for nicotine dependence that looks at how participant's thoughts and feelings about smoking may be related to how successfully they quit smoking.
If patient agrees to participate, they will receive free treatment to help them quit smoking,
including written self-help materials, counseling, and a supply of the nicotine patch for 4
weeks. Participant will visit M. D. Anderson 5 times during this study; once for an
orientation/intake visit, and then for 4 more study visits.
At the first (orientation) visit, participant will be asked about their feelings and moods,
as well as their smoking status. Participant will fill out questionnaires on a computer and
complete a breath test. The questionnaires will be about mood, stress, and smoking-related
issues, and should take about 1 hour and 30 minutes to complete. To complete the breath test,
participant will blow into a tube that's attached to a machine about the size of a pocket
computer. The breath test is used to estimate the amount of tobacco smoke that participant
inhales. Participant will also complete two computer-based tasks. Women who are pregnant
should not take part in this study.
In addition, participant will receive a palmtop personal computer and be trained in how to
use it. Participant will carry this small computer with them from the time of their first
visit until their last study visit. Participant will use the computer to answer questions
about their mood, stress, and smoking-related issues. Participant will be asked to fill out
some questions on the computer each time they have an urge to smoke or they actually smoke.
Also, the computer will "beep" at random and set times and request that participant answers
some questions.
Participant will return for 4 visits after the orientation session. During these visits,
participant will receive brief individual counseling where they will discuss techniques to
help them quit smoking. Participant will also be asked to fill out questionnaires on a
computer about their moods and feelings, as well as their smoking status. The questionnaires
should take about 30 minutes to complete. The breath test will be given at every clinic
visit.
Participant may be contacted by mail, telephone, and/or e-mail throughout the study and
follow-up period, to provide reminders of clinic visits. Participant may also be asked for
information about their smoking status during the usual reminder calls and/or calls to
reschedule missed appointments.
A supply of the nicotine patch will be provided to participant at each counseling session.
The final supply of the patch is provided at the final counseling session.
This is an investigational study. The nicotine patch used in this study is approved by the
Food and Drug Administration (FDA). About 20 people will take part in a pilot phase of this
study; then, another 200 participants will take part in the main study. All will be enrolled
at M. D. Anderson.
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