Clinical trial NCT00721786: Internet Stop Smoking Study - Phase VI
Official title: Internet Health Research Center: Smoking, Latinos, and the Web
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking cessation
Cigarette smoking
Tobacco smoking
Internet interventions
Spanish-speaking
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 18154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Smoking abstinence
timeFrame: 1, 3, 6 and 12 month follow-ups
Secondary outcomes:
measure: Depression
timeFrame: 1, 3, 6, and 12 month follow-ups
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco SFGH Psychiatry
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ricardo F. Muñoz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.