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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Centers for Disease Control and Prevention |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00384696 |
Primary Objectives:
Condition | Intervention | Phase |
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Smoking |
Behavioral: Nicotine Replacement Therapy Behavioral: Questionnaire |
Phase I |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Health Communications and Risk Processing Among Smokers |
Estimated Enrollment: | 220 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Treatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits.
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Behavioral: Nicotine Replacement Therapy
4 Weeks of nicotine patch.
Behavioral: Questionnaire
Survey taking 1 and 1/2 hours at each study visit.
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If you agree to participate, 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. You 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, you will be asked about your feelings and moods, as well as your smoking status. You 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, you 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 you inhale. You will also complete two computer-based tasks. Women who are pregnant should not take part in this study.
In addition, you will receive a palmtop personal computer and be trained in how to use it. You will carry this small computer with you from the time of your first visit until your last study visit. 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.
You will return for 4 visits after the orientation session. During these visits, you will receive brief individual counseling where you will discuss techniques to help you quit smoking. You will also be asked to fill out questionnaires on a computer about your moods and feelings, as well as your smoking status. The questionnaires should take about 30 minutes to complete. The breath test will be given at every clinic visit.
You may be contacted by mail, telephone, and/or e-mail throughout the study and follow-up period, to provide reminders of 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.
A supply of the nicotine patch will be provided to you 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Current smoker, age 18 to 65 years, with history of 5 cigarettes/day for last year wishing to quit.
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Jennifer Irvin Vidrine, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Jennifer Irvin Vidrine, PhD ) |
Study ID Numbers: | 2004-0806 |
Study First Received: | October 4, 2006 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00384696 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Risk Perception Smoking Cessation Nicotine Replacement Therapy Questionnaire Nicotine |
Nicotine polacrilex Smoking Neurotransmitter Agents Nicotine |
Nicotinic Agonists Peripheral Nervous System Agents Cholinergic Agents |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |
Smoking Habits Nicotine Autonomic Agents Ganglionic Stimulants Peripheral Nervous System Agents |