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View Clinical Trial (Medical Research Study)
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College Students and Smoking Cessation - NCT00941395-77004 (Clinical Trial 302453)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy302453.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77004 |
| Conditions: |
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Smoking Cessation - Habits - Smoking |
| Purpose: |
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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,
researchers 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.
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| Study summary: |
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Non-Smokers (Smoking Prevention)
Internet Survey:
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 6 months.
This is an investigational study. The use of this program to help prevent smoking is
investigational.
Up to 160 people will take part in this multicenter study. Up to 80 participants will take
part in the "non-smokers" part of this multicenter study. Up to 40 will be enrolled at the
University of Houston Central Campus and up to 40 will be enrolled at Texas A&M University.
Smokers (Smoking Cessation)
Study Visits:
If you agree to take part in this study, you will have a baseline visit and study visits at
1 week, 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.
- 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.
- 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.
At the 1-week visit, the following tests and procedures will be performed:
- The study staff will discuss the results of the lung function test and the carbon
monoxide test with you.
- You will speak with a member of the study about how to quit smoking and your personal
goals for quitting.
- You will be asked about any nicotine lozenges you may have used.
Internet Surveys:
You will be asked to complete 3 surveys on the internet over the 3 months between the 1-week
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. |
| Criteria: |
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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
Exclusion Criteria:
1. CESSATION ARM: Evidence of major depressive disorder (as defined by SCID [Structured
Clinical Interview for Diagnostic and Statistical Manual Disorders] measure)
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 |
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| Study is available at: |
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University of Houston Central Campus
Houston, TX 77004
United States
Primary Contact:
Alex Prokhorov, MD, PHD
Phone: 713-745-2382 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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