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College Students and Smoking Cessation - NCT00941395-77004(Clinical Trial 302453)



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City:  Houston
State:  
TX
Zip Code: 77004
Conditions: Smoking Cessation - Habits - Smoking
Purpose: Objectives: This study will help to establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression. In addition, we will demonstrate the feasibility of a smoking prevention website. Both cessation and prevention programs will be tailored to the needs of culturally diverse urban (University of Houston) and rural (Texas A&M) university campuses.
Study summary: Internet Survey: (Non Smokers) If you agree to take part in this study, you will be emailed an Internet survey. The survey will have questions about your attitudes about smoking and health. The survey should take about 20 minutes to complete. Email Messages: You will be emailed messages with information and links about the health risks of smoking, the environmental and financial impact of smoking, and the importance of healthy behaviors, such as stress and weight management. You will receive these messages every week for 3 months (12 messages). End-of-Study Visit: You will have an end-of-study visit at 6 months. You will have a saliva sample collected to check your smoking status. To collect a saliva sample, you will spit into a small plastic container. You will also fill out the same survey you completed at the beginning of the study. Length of Study: You will be on study for up to 9 months. This is an investigational study. The use of this program to help prevent smoking is investigational. Up to 200 people will take part in this multicenter study. Up to 100 participants will take part in the "nonsmokers" part of this multicenter study. Up to 50 will be enrolled at the University of Houston Central Campus and up to 50 will be enrolled at Texas A&M University. Study Visits: (Smokers) If you agree to take part in this study, you will have a baseline visit and study visits at 3 months and 6 months. At the baseline visit, the following tests and procedures will be performed: - You will have a lung function test to learn how well your lungs work. To perform a lung function test, you will take a deep breath and blow into a mouthpiece that is connected to a device that records how much air your lungs can hold and shows how much force you use when breathing out. - Your carbon monoxide levels will be checked. You will breathe gently into a different machine that records how much carbon monoxide is in your lungs. - The study staff will discuss the results of the lung function test and the carbon monoxide test with you. - You will have an interview about your tobacco use. You will be asked how much tobacco you use, about any time(s) you have tried to quit, how ready you are to quit, and how dependent you are on nicotine. You will also be asked about your overall mood and how often you use alcohol. - You will speak with a member of the study about how to quit smoking and your personal goals for quitting. - The study staff will give you instructions on how to receive nicotine lozenges from the on-campus pharmacy. The on-campus pharmacy will provide detailed instruction on how to use the lozenges. - The study staff will also tell you about a website designed for this study. The website will have helpful tips and information on quitting smoking. A blog will also be available where you can post comments and start discussions. The study staff will teach you how to access and use the study website and blog. Internet Surveys: You will be asked to complete 3 surveys on the Internet over the 3 months between the baseline visit and the 3-month visit. The surveys will have questions based on your goals for quitting smoking, your responses from the tobacco use interview, and your answers from previous surveys. The surveys should take about 20 minutes to complete. After you complete the first survey, you will receive a personalized newsletter on the study website based on the answers from your surveys, your lung tests, and the tobacco use interviews. You will be able to access and print the newsletter from the website. At the 3-month visit, the following tests and procedures will be performed: - Your carbon monoxide levels will be checked. - You will have an interview about your tobacco use. - You will discuss any progress you have made in quitting smoking and any problems you have had with the program. At the 6-month visit, the following tests and procedures will be performed: - You will have a saliva sample collected to check your smoking status. To collect a saliva sample, you will spit into a small plastic container. - You will have an interview about your tobacco use. All study visits should take about 1 hour. Follow-up Phone Calls: The study staff will call you 2 months and 4 months after the 6-month visit. You will be asked about your progress in quitting smoking and if you would like any help or counseling to help you quit. The phone calls should take about 30 minutes. Length of Study: You may be on study for up to 15 months. This is an investigational study. The use of this program to help quit smoking is investigational. Up to 200 people will take part in this multicenter study. Up to 100 participants will take part in the "smokers" part of this multicenter study. Up to 50 will be enrolled at the University of Houston Central Campus and up to 50 will be enrolled at Texas A&M University.
Criteria: Inclusion Criteria: 1. CESSATION ARM: Student at University of Houston Central Campus or Texas A&M University 2. CESSATION ARM: Smoke 1 or more cigarettes a day 3. CESSATION ARM: Speak and read English 4. CESSATION ARM: Signed Informed Consent and an acknowledgement of participation requirements 5. CESSATION ARM: 18-35 years of age 6. CESSATION ARM: Be enrolled in at least one class at respective campus at baseline 7. CESSATION ARM: Provide current contact information 8. CESSATION ARM: Have access to the Internet 9. PREVENTION ARM: Student at University of Houston Central Campus or Texas A&M University 10. PREVENTION ARM: Speak and read English 11. PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements 12. PREVENTION ARM: 18-35 years of age 13. PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline 14. PREVENTION ARM: Provide current contact information 15. PREVENTION ARM: Have access to the Internet 16. PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale) Exclusion Criteria: 1. CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9]) 2. CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT [Alcohol Use Disorders Identification Test] measure) 3. PREVENTION ARM: Current tobacco use 4. PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year 5. CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year 6. PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9]) 7. PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)
Study is available at: University of Houston Central Campus
Houston, TX 77004
United States

Primary Contact:
Alex Prokhorov, MD, PHD
Phone: 713-745-2382
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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