SmokingTC4NCT00721786
Internet Stop Smoking Study - Phase VI
A study testing UCSF/SFGH Internet Stop Smoking Study site in people with Smoking, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- UCSF/SFGH Internet Stop Smoking Study site
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,154 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years old or above)
- must have email
- logging on to our stop smoking Internet site
- providing consent to enter stop smoking study
Who cannot join
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco SFGH Psychiatry
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- UCSF/SFGH Internet Stop Smoking Study site
- Keywords
- Smoking cessation, Cigarette smoking, Tobacco smoking, Internet interventions, Spanish-speaking
- Medical subject headings
- Smoking, Smoking Cessation, Cigarette Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCSF/SFGH Internet Stop Smoking Study siteBehavioural
Also called The interventions being tested can be accessed online at:, www.stopsmoking.ucsf.edu, www.dejardefumar.ucsf.edu
Internet stop smoking site in Spanish and English
| Study group | Role | What they receive |
|---|---|---|
| San Francisco Internet Stop Smoking Site | Experimental | 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 Receives: Behavioral: UCSF/SFGH Internet Stop Smoking Study site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
Not smoking even one cigarette in the past 7 days.
Measured: 1, 3, 6 and 12 month follow-ups
Secondary outcomes (1)
Depression
Center for Epidemiological Studies Depression scale
Measured: 1, 3, 6, and 12 month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18,154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo F. Muñoz, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721786
- Sponsor's protocol ID
- IWHRC-RFM-SMK-PhVI
- Acronym
- TC4
- Status last verified
- Nov 2018
- First submitted
- 22 Jul 2008
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19640833Munoz 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.
PubMed 16497602Torres 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.
PubMed 19627638Barrera 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.
PubMed 19440423Munoz 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.
PubMed 22739225Leykin 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.
PubMed 22314016
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Health Research Center: Smoking, Latinos, and the Web
- ClinicalTrials.gov ID
- NCT00721786
- Acronym / sponsor ID
- TC4 / IWHRC-RFM-SMK-PhVI
- Conditions
- Smoking
- Keywords
- Smoking cessation, Cigarette smoking, Tobacco smoking, Internet interventions, Spanish-speaking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,154 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| San Francisco Internet Stop Smoking Site | Experimental | Behavioral: UCSF/SFGH Internet Stop Smoking Study siteUCSF/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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18 years old or above)
- must have email
- logging on to our stop smoking Internet site
- providing consent to enter stop smoking study
Key exclusion criteria (1 listed)
- Younger than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCSF/SFGH Internet Stop Smoking Study siteAlso: The interventions being tested can be accessed online at:, www.stopsmoking.ucsf.edu, www.dejardefumar.ucsf.eduInternet stop smoking site in Spanish and English | Behavioural | San Francisco Internet Stop Smoking Site |
Primary outcome
Smoking abstinence
Time frame: 1, 3, 6 and 12 month follow-ups
Not smoking even one cigarette in the past 7 days.
1 secondary outcome
Depression
Time frame: 1, 3, 6, and 12 month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Background: PubMed 19640833Munoz 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.
- Background: PubMed 16497602Munoz 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.
- Background: PubMed 19627638Torres 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.
- Background: PubMed 19440423Barrera 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.
- Derived from this study: PubMed 22739225Munoz 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.
- Derived from this study: PubMed 22314016Leykin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo F. Muñoz, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCSF/SFGH Internet Stop Smoking Study site in people with Smoking, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence (time frame: 1, 3, 6 and 12 month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00721786, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.