- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721786
Internet Stop Smoking Study - Phase VI (TC4)
Internet Health Research Center: Smoking, Latinos, and the Web
The purpose of this study is to determine the percentage of English- and Spanish-speaking smokers worldwide who can stop smoking using an Internet stop smoking site.
Latinos and non-Latinos are welcome to participate.
We will stop recruitment on March 19, 2011. Participants will be able to use the site until May 19, 2011.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is Phase VI of a series of clinical trials comparing various Internet methods to help smokers quit via the Internet.
Our previous trials have involved randomized assignment. This trial is a participant preference trial, in which English- and Spanish-speaking smokers will be able to choose the elements of the site which they would like to use to stop smoking.
Smokers who find our link via search engines or listing on other Web sites may choose to enter the study.
Participants must be 18 years old to enter the study. Participants will be followed up at 1, 3, 6, and 12 months after entry into the study to determine whether they have stopped smoking. They will receive an email reminder with a link to our follow-up surveys. We will stop sending these email reminders on May 19, 2011, when the current Website will close.
Participation is totally voluntary. Participants are free not to provide data or to stop participating at any time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- University of California, San Francisco SFGH Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult (18 years old or above)
- must have email
- logging on to our stop smoking Internet site
- providing consent to enter stop smoking study
Exclusion Criteria:
- Younger than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: San Francisco Internet Stop Smoking Site
UCSF/SFGH Internet Stop Smoking Study site Internet Stop Smoking site (TC4) with several intervention elements from which the participants may choose as many as they wish The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu Spanish: www.dejardefumar.ucsf.edu |
Internet stop smoking site in Spanish and English
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking abstinence
Time Frame: 1, 3, 6 and 12 month follow-ups
|
Not smoking even one cigarette in the past 7 days.
|
1, 3, 6 and 12 month follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: 1, 3, 6, and 12 month follow-ups
|
Center for Epidemiological Studies Depression scale
|
1, 3, 6, and 12 month follow-ups
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ricardo F. Muñoz, Ph.D., University of California, San Francisco
Publications and helpful links
General Publications
- Munoz RF, Barrera AZ, Delucchi K, Penilla C, Torres LD, Perez-Stable EJ. International Spanish/English Internet smoking cessation trial yields 20% abstinence rates at 1 year. Nicotine Tob Res. 2009 Sep;11(9):1025-34. doi: 10.1093/ntr/ntp090. Epub 2009 Jul 29.
- Munoz RF, Lenert LL, Delucchi K, Stoddard J, Perez JE, Penilla C, Perez-Stable EJ. Toward evidence-based Internet interventions: A Spanish/English Web site for international smoking cessation trials. Nicotine Tob Res. 2006 Feb;8(1):77-87. doi: 10.1080/14622200500431940.
- Torres LD, Barrera AZ, Delucchi K, Penilla C, Perez-Stable EJ, Munoz RF. Quitting smoking does not increase the risk of major depressive episodes among users of Internet smoking cessation interventions. Psychol Med. 2010 Mar;40(3):441-9. doi: 10.1017/S0033291709990560. Epub 2009 Jul 23.
- Barrera AZ, Perez-Stable EJ, Delucchi KL, Munoz RF. Global reach of an Internet smoking cessation intervention among Spanish- and English-speaking smokers from 157 countries. Int J Environ Res Public Health. 2009 Mar;6(3):927-40. doi: 10.3390/ijerph6030927. Epub 2009 Feb 26.
- Munoz RF, Aguilera A, Schueller SM, Leykin Y, Perez-Stable EJ. From online randomized controlled trials to participant preference studies: morphing the San Francisco Stop Smoking site into a worldwide smoking cessation resource. J Med Internet Res. 2012 Jun 27;14(3):e64. doi: 10.2196/jmir.1852.
- Leykin Y, Aguilera A, Torres LD, Perez-Stable EJ, Munoz RF. Interpreting the outcomes of automated internet-based randomized trials: example of an International Smoking Cessation Study. J Med Internet Res. 2012 Feb 7;14(1):e5. doi: 10.2196/jmir.1829.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IWHRC-RFM-SMK-PhVI
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