Smoking CessationNCT02515500
Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial
A study testing Gradual Cessation and Gradual Cessation w/ Quitbit in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Gradual Cessation and Gradual Cessation w/ Quitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2018
- 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
- 18 years of age
- cigarette smoker
- wanting to quit in the next 30 days
- preference to quit gradually (vs. abruptly) or having no preference
- access to an iPhone (iOS only)
- completion of a run-in period
Who cannot join
- no major change in number of cigarettes per day in the past month (+/- 20%)
- no major health diagnoses that could impact study attrition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94122
About this study
The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.
- Conditions
- Smoking Cessation
- Being tested
- Gradual Cessation, Gradual Cessation w/ Quitbit
- Keywords
- cigarette reduction, digital health, mobile health, technology, Quitbit, mHealth, smoking cessation, quit smoking, self-regulation
- Medical subject headings
- Smoking Cessation, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gradual CessationBehavioural
Also called Cigarette Reduction
Gradual Cessation w/ QuitbitBehavioural
Also called Cigarette Reduction w/ Quitbit
| Study group | Role | What they receive |
|---|---|---|
| Gradual Cessation | Active comparator | Not described Receives: Behavioral: Gradual Cessation |
| Gradual Cessation w/ Quitbit | Experimental | Not described Receives: Behavioral: Gradual Cessation w/ Quitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva cotinine level
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Quitbit, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515500
- Sponsor's protocol ID
- 16-18722
- Status last verified
- Jan 2020
- First submitted
- 30 Jul 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02515500
- Acronym / sponsor ID
- 16-18722
- Conditions
- Smoking Cessation
- Keywords
- cigarette reduction, digital health, mobile health, technology, Quitbit, mHealth, smoking cessation, quit smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Quitbit, Inc.
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 Aug 2015 (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 study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gradual Cessation | Active comparator | Behavioral: Gradual Cessation |
| Gradual Cessation w/ Quitbit | Experimental | Behavioral: Gradual Cessation w/ Quitbit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age
- cigarette smoker
- wanting to quit in the next 30 days
- preference to quit gradually (vs. abruptly) or having no preference
- access to an iPhone (iOS only)
Key exclusion criteria (2 listed)
- no major change in number of cigarettes per day in the past month (+/- 20%)
- no major health diagnoses that could impact study attrition
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 |
|---|---|---|
| Gradual CessationAlso: Cigarette Reduction | Behavioural | Gradual Cessation |
| Gradual Cessation w/ QuitbitAlso: Cigarette Reduction w/ Quitbit | Behavioural | Gradual Cessation w/ Quitbit |
Primary outcome
Saliva cotinine level
Time frame: 6 Months
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 13 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gradual Cessation and Gradual Cessation w/ Quitbit in people with Smoking Cessation, 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 6 inclusion and 2 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 13 Jan 2020. 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?
Saliva cotinine level (time frame: 6 Months). 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 13 Jan 2020.