Internet Stop Smoking Study - Phase VI - Full Text View

Purpose

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.

Condition	Intervention
Smoking	Behavioral: UCSF/SFGH Internet Stop Smoking Study site

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Internet Health Research Center: Smoking, Latinos, and the Web

Resource links provided by NLM:

MedlinePlus related topics: Smoking

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Smoking abstinence [ Time Frame: 1, 3, 6 and 12 month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression [ Time Frame: 1, 3, 6, and 12 month follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment:	110000
Study Start Date:	September 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: San Francisco Internet Stop Smoking 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	Behavioral: UCSF/SFGH Internet Stop Smoking Study site Internet stop smoking site in Spanish and English Other Names: The interventions being tested can be accessed online at: www.stopsmoking.ucsf.edu www.dejardefumar.ucsf.edu

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721786

Locations

United States, California
University of California, San Francisco SFGH Psychiatry
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Ricardo F. Muñoz, Ph.D.

University of California, San Francisco

More Information

Additional Information:

Internet Stop Smoking Study Web site This link exits the ClinicalTrials.gov site

Publications:

Muñoz RF, Barrera AZ, Delucchi K, Penilla C, Torres LD, Pérez-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. Epub 2009 Jul 29.

Muñoz RF, Lenert LL, Delucchi K, Stoddard J, Perez JE, Penilla C, Pérez-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.

Torres LD, Barrera AZ, Delucchi K, Penilla C, Pérez-Stable EJ, Muñoz RF. Quitting smoking does not increase the risk of major depressive episodes among users of Internet smoking cessation interventions. Psychol Med. 2009 Jul 23;:1-9 [Epub ahead of print]

Barrera AZ, Pérez-Stable EJ, Delucchi KL, Muñoz 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. Epub 2009 Feb 26.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Muñoz RF, Aguilera A, Schueller SM, Leykin Y, Pérez-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.

Leykin Y, Aguilera A, Torres LD, Pérez-Stable EJ, Muñoz 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.

Responsible Party:	Ricardo F. Muñoz, Ph.D., Professor of Psychology and Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00721786 History of Changes
Other Study ID Numbers:	IWHRC-RFM-SMK-PhVI, CHR H928-14936-14
Study First Received:	July 22, 2008
Last Updated:	July 25, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Smoking cessation
Cigarette smoking
Tobacco smoking
Internet interventions
Spanish-speaking

Additional relevant MeSH terms:

Smoking
Habits

ClinicalTrials.gov processed this record on May 22, 2013

Internet Stop Smoking Study - Phase VI (TC4)