Overview

This trial is active, not recruiting.

Condition smoking
Treatments nicotine replacement therapy, questionnaire
Phase phase 1
Sponsor M.D. Anderson Cancer Center
Collaborator Centers for Disease Control and Prevention
Start date February 2006
End date December 2017
Trial size 220 participants
Trial identifier NCT00384696, 1 K01 CD000193-01, 2004-0806

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Treatment to help quit smoking, including written self-help materials, counseling, and 4 week supply of nicotine patch plus 5 MD Anderson Visits.
nicotine replacement therapy
4 Weeks of nicotine patch. Patch therapy for participants who smoke >10 cigarettes/day consists of 2 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 2 weeks of 14 mg patches and 2 weeks of 7 mg patches.
questionnaire
Survey taking 1 and 1/2 hours at each study visit.

Primary Outcomes

Measure
Risk Perceptions Over Time Among Smokers and Non Smokers
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Age 18 to 65 years. 2. Current smoker with a history of at least 5 cigarettes/day for the last year 3. Motivated to quit within the next week. 4. Home address and a functioning home telephone number. 5. Can speak, read, and write in English at a sixth-grade literacy level. Exclusion Criteria: 1. Contraindication for nicotine patch use. 2. Active substance abuse or dependence. 3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless). 4. Use of bupropion or nicotine products other than the nicotine patches supplied by the study. 5. Pregnancy or lactation. 6. Another household member enrolled in the study. 7. Participation in a smoking cessation program or study during the past 90 days.

Additional Information

Official title Health Communications and Risk Processing Among Smokers
Principal investigator Lorna H. McNeill, PHD, MPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.