Cigarette SmokingTC-PAU-1NCT02103829
"Quit Smoking on Your Own" Brief Online Study
A study testing Brief Intervention #1, Brief Intervention #2 and Brief Intervention #3 in people with Cigarette Smoking, run by i4Health at 1 site in United States.
Trial summary
Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on their own. The purpose of this study is to determine whether very brief suggestions provided online are comparatively more effective than others in increasing motivation to quit immediately after the suggestions are implemented… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Brief Intervention #1, Brief Intervention #2 and Brief Intervention #3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Sep 2016
- 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 of age or older)
- Smoker who wants to quit
- Access to the Internet
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto University i4Health
Palo Alto, California, 94304
About this study
Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on their own. The purpose of this study is to determine whether very brief suggestions provided online are comparatively more effective than others in increasing motivation to quit immediately after the suggestions are implemented and actual quit rates one month later.
There are no costs associated with participating in this study and participants will not be compensated for their participation.
To join the study paste the following link into your browser:
https://www.i4health-pau.org/quit-smoking-on-your-own
The entire study takes place online on an automated website.
Read the detailed description
Participants will be recruited online using search engine ads (e.g., Google), online association list serves, community websites designed to reach individuals interested in participating in research studies, and social media sites related to smoking cessation efforts.
The entire study will be administered online. Participants may complete it at a time and place of their convenience.
To join the study paste the following link into your browser:
https://www.i4health-pau.org/quit-smoking-on-your-own
The website will automatically obtain consent, ask 16 brief questions as a pre-test, randomize to 4 very brief interventions, ask 4 post-test questions, and at 1-month follow-up, send an email with a link to a 6-question survey. The initial online session is expected to take between 3 and 8 minutes and the 1-month follow-up survey less than 2 minutes.
- Conditions
- Cigarette Smoking
- Being tested
- Brief Intervention #1, Brief Intervention #2, Brief Intervention #3
- Keywords
- Cigarette smoking, Tobacco smoking, Smoking, Tobacco
- Medical subject headings
- Cigarette Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention #1Behavioural
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Brief Intervention #2Behavioural
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Brief Intervention #3Behavioural
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 7 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Condition #1 | Active comparator | Condition #1 will consist of Brief Intervention #1, a brief online suggestion that takes less than 1 minute to complete. Receives: Behavioral: Brief Intervention #1 |
| Condition #2 | Experimental | Condition #2 will consist of Brief Intervention #1 and Brief Intervention #2 that together take less than a minute to complete. Receives: Behavioral: Brief Intervention #1; Behavioral: Brief Intervention #2 |
| Condition #3 | Experimental | Condition #3 will consist of Brief Intervention #1 and Brief Intervention #3, which, together, will take less than 8 minutes to complete. Receives: Behavioral: Brief Intervention #1; Behavioral: Brief Intervention #3 |
| Condition #4 | Experimental | Condition #4 will consist of Brief Intervention #1, Brief Intervention #2, and Brief Intervention #3, which, together, will take less than 8 minutes to complete. Receives: Behavioral: Brief Intervention #1; Behavioral: Brief Intervention #2; Behavioral: Brief Intervention #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who report quitting smoking
Percentage of respondents who respond "no" to the question: "Have you smoked 1 or more cigarettes in the last 7 days?"
Measured: 1 month
Secondary outcomes (1)
Motivation to quit smoking
Pre-post measure of motivation before and after the brief suggestions being tested are administered online. Specifically, response on a 0 to 10 scale (from "not at all" to "extremely") to the question "How motivated are you to stop smoking in the next 4 weeks?"
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- i4Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo F. Muñoz, Ph.D., i4Health
- Investigators
- Ricardo F Muñoz, Ph.D., Principal investigator, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103829
- Sponsor's protocol ID
- TC-PAU-1
- Acronym
- TC-PAU-1
- Status last verified
- Sep 2016
- First submitted
- 1 Apr 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Quit Smoking on Your Own" Brief Online Study
- ClinicalTrials.gov ID
- NCT02103829
- Acronym / sponsor ID
- TC-PAU-1 / TC-PAU-1
- Conditions
- Cigarette Smoking
- Keywords
- Cigarette smoking, Tobacco smoking, Smoking, Tobacco
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 345 participants (actual)
- Lead sponsor
- i4HealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Apr 2014 (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.
Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on their own. The purpose of this study is to determine whether very brief suggestions provided online are comparatively more effective than others in increasing motivation to quit immediately after the suggestions are implemented and actual quit rates one month later.
There are no costs associated with participating in this study and participants will not be compensated for their participation.
To join the study paste the following link into your browser:
https://www.i4health-pau.org/quit-smoking-on-your-own
The entire study takes place online on an automated website.
Detailed description
Participants will be recruited online using search engine ads (e.g., Google), online association list serves, community websites designed to reach individuals interested in participating in research studies, and social media sites related to smoking cessation efforts.
The entire study will be administered online. Participants may complete it at a time and place of their convenience.
To join the study paste the following link into your browser:
https://www.i4health-pau.org/quit-smoking-on-your-own
The website will automatically obtain consent, ask 16 brief questions as a pre-test, randomize to 4 very brief interventions, ask 4 post-test questions, and at 1-month follow-up, send an email with a link to a 6-question survey. The initial online session is expected to take between 3 and 8 minutes and the 1-month follow-up survey less than 2 minutes.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Condition #1 | Active comparator | Behavioral: Brief Intervention #1Condition #1 will consist of Brief Intervention #1, a brief online suggestion that takes less than 1 minute to complete. |
| Condition #2 | Experimental | Behavioral: Brief Intervention #1, Behavioral: Brief Intervention #2Condition #2 will consist of Brief Intervention #1 and Brief Intervention #2 that together take less than a minute to complete. |
| Condition #3 | Experimental | Behavioral: Brief Intervention #1, Behavioral: Brief Intervention #3Condition #3 will consist of Brief Intervention #1 and Brief Intervention #3, which, together, will take less than 8 minutes to complete. |
| Condition #4 | Experimental | Behavioral: Brief Intervention #1, Behavioral: Brief Intervention #2, Behavioral: Brief Intervention #3Condition #4 will consist of Brief Intervention #1, Brief Intervention #2, and Brief Intervention #3, which, together, will take less than 8 minutes to complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years of age or older)
- Smoker who wants to quit
- Access to the Internet
Key exclusion criteria (1 listed)
- Less than 18 years of age
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 |
|---|---|---|
| Brief Intervention #1Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete. | Behavioural | Condition #1, Condition #2, Condition #3, Condition #4 |
| Brief Intervention #2Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete. | Behavioural | Condition #2, Condition #4 |
| Brief Intervention #3Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 7 minutes to complete. | Behavioural | Condition #3, Condition #4 |
Primary outcome
Percentage of participants who report quitting smoking
Time frame: 1 month
Percentage of respondents who respond "no" to the question: "Have you smoked 1 or more cigarettes in the last 7 days?"
1 secondary outcome
Motivation to quit smoking
Time frame: 10 minutes
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
Related trials for Cigarette Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
RecruitingEarly Phase 1
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Cigarette Smoking-Related Carcinoma
Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
Tobacco Products, Cigarettes
Active, not recruiting
A Novel Dialectical Behavior Therapy Brief Group Intervention for Cigarette Smoking by Patients With Cancer: An Open Clinical Trial
Smoking Behavior
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
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
Palo Alto University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention #1, Brief Intervention #2 and Brief Intervention #3 in people with Cigarette Smoking, run by i4Health 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 3 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: stopped early, as of the sponsor's last update on 29 Sep 2016. 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 was stopped early. Results are not available in the source record.
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?
Percentage of participants who report quitting smoking (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2016.