Smoking CessationPhase 2Tweet2QuitNCT02823028
Twitter-enabled Mobile Messaging for Smoking Relapse Prevention (Tweet2Quit)
A Phase 2 study testing NRT, Web Guide and Tweet2Quit in people with Smoking Cessation, run by University of California, Irvine at 2 sites in United States.
Trial summary
Tweet2Quit is an innovative smoking cessation intervention that combines real-time online peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only. Read more about this study
- Who is it for?
- Ages 21 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- NRT, Web Guide and Tweet2Quit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 980 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are 21-59 years of age
- Are smoking 5+ cigarettes/day and 100+ cigarettes in one's lifetime
- In the preparation stage of quitting smoking
- Are English speaking
- Have a mobile phone with an unlimited texting plan and internet access (via mobile phone)
- Text at least once a week
Show all 9Show fewer
- Are a social media user
- Have an active email account
- Lives in the continental USA
Who cannot join
- Have certain medical conditions that are contraindicated for nicotine replacement therapy: pregnant, breast feeding, a recent heart attack, an irregular heartbeat, high blood pressure not controlled with medication, skin allergies to adhesive tape or serious skin problems, taking a prescription medicine for depression, and/or any other medical conditions that would prevent you from completing this study.
- Are an illicit hard drug user or regular marijuana user
- Share a household with someone else or has an immediate family member who has already enrolled in the study currently or in the past or if the participant has already been enrolled or failed to pass the screening once already since October 2016
- Participated in Tweet2Quit between 2012-2013 in a Twitter group and was not an active tweeter (<1 week)
- Fails to provide valid forms of all the required personal contact information
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Irvine - Paul Merage School of Business
Irvine, California, 92697
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Social Media Technology for Treating Tobacco Addiction
Tweet2Quit is an innovative smoking cessation intervention that combines real-time online peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Read the detailed description
The proposed randomized controlled evaluation of the Tweet2Quit intervention will biochemically verify abstinence out to 6-months follow-up and will test the personalized benefit for women of a women-only versus co-ed Tweet2Quit group. In a 3-arm design, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Each Tweet2Quit group will include buddy pairs based on similarity in demographics. Also automated pattern detection will identify dips in tweeting and trigger automated alerts and engagement strategies.
The sample consists of 960 adult smokers plus 20 in an initial pilot group to check technology functionality (not included in outcome assessment).
The primary aims test Hypothesis 1: Relative to usual care (n=240), Tweet2Quit-coed groups (n=480) will achieve significantly greater bioconfirmed sustained abstinence out to 6-months follow-up for each gender, and Hypothesis 2: Women in Tweet2Quit will achieve significantly greater bioconfirmed 6-months abstinence in woman-only groups (n=240) vs. coed groups (n=240 women).
Our secondary aims are to test the same hypotheses based on 3-month (end of treatment) sustained abstinence and 7-day point prevalence at 1, 3, and 6 months with biochemical verification at 3 and 6 months. Exploratory aims will study the Tweet2Quit groups' social network structures with a focus on the identification of buddy pairs and social brokers and test if these relationships are stronger for women in women-only groups versus women in coed groups of Tweet2Quit.
*Prior to the start of the RCT, the investigators will run one coed pilot group (N=20). Total size of the study (including the pilot group) will be N=980.
- Conditions
- Smoking Cessation
- Being tested
- NRT, Web Guide, Tweet2Quit
- Keywords
- Smoking, Social Media, Twitter, Behavior Change, Social Support
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRTDrug
Also called Nicotine Replacement Therapy
8-weeks of study provided NRT patch, and 8-weeks of study provided NRT gum of varying strengths or 8-weeks of study provided NRT lozenges, depending on patient level of nicotine dependence.
Web GuideBehavioural
A website that will provide participants with access to an evidence-based set of "base" treatment materials in one central location. The site will include information on the proper use of nicotine patches, gum, lozenges, and it will have a direct link for participants to access the NCI's Smokefree.gov Quit Guide. The website will remind participants about quit dates and send alerts via email to participants to complete the appropriate NCI Quit Guide modules.
Tweet2QuitBehavioural
A fully automated, 90-day quit smoking intervention that provides an online, peer-to-peer support group for quitting and uses twice-daily automessages to encourage and direct the peer-to-peer exchanges. Each group will consist of 12 buddy pairs (matched on key demographics) that will be introduced via automated texts. The program will generate twice-daily programmed contacts (e.g., "what benefits do you hope to get from quitting smoking?"). Automated pattern detection software will identify and address any problematic low tweeting within a group.
| Study group | Role | What they receive |
|---|---|---|
| NRT + Web Guide | Active comparator | NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) Receives: Drug: NRT; Behavioral: Web Guide |
| NRT + Web Guide + Tweet2Quit-Coed | Experimental | NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group Receives: Drug: NRT; Behavioral: Web Guide; Behavioral: Tweet2Quit |
| NRT + Web Guide + Tweet2Quit-Women | Experimental | Experimental: NRT + Web Guide + Tweet2Quit-Women NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a women-only Tweet2Quit group Receives: Drug: NRT; Behavioral: Web Guide; Behavioral: Tweet2Quit |
| Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed) | Other | The initial pilot group was run to check technology functionality and user acceptance; it was not included in outcome assessments. These participants received NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group. Receives: Drug: NRT; Behavioral: Web Guide; Behavioral: Tweet2Quit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a 6-month Sustained Abstinence
Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times have you used e-cigs' since the quit date (assessed at 1, 3 and 6 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 and 6 months post quit date). Note: We will apply the Russell Standard for abstinence, allowing 5 or fewer instances of tobacco use over 6 months.
In our primary (most rigorous) analysis, we will consider a cotinine-positive test, regardless of source, to be non-abstinent. In additional analyses, we will code as abstinent those who assert tobacco abstinence but continue use of FDA-approved nicotine replacement therapy. In other analyses we will report results with ENDS-only users coded first as non-abstinent and then for comparison as abstinent.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Cornelia Pechmann, University of California, Irvine
- Investigators
- Connie (Cornelia) Pechmann, PhD, MBA, MS, Principal investigator, University of California, IrvineJudith J Prochaska, PhD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823028
- Sponsor's protocol ID
- 20141303
- Other IDs
- R01CA204356
- Acronym
- Tweet2Quit
- Status last verified
- Nov 2024
- First submitted
- 16 Jun 2016
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pechmann C, Phillips C, Calder D, Prochaska JJ. Facebook Recruitment Using Zip Codes to Improve Diversity in Health Research: Longitudinal Observational Study. J Med Internet Res. 2020 Jun 5;22(6):e17554. doi: 10.2196/17554.
PubMed 32501274Pechmann CA, Calder D, Phillips C, Delucchi K, Prochaska JJ. The Use of Web-Based Support Groups Versus Usual Quit-Smoking Care for Men and Women Aged 21-59 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jan 14;9(1):e16417. doi: 10.2196/16417.
PubMed 31934869
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media Technology for Treating Tobacco Addiction
- ClinicalTrials.gov ID
- NCT02823028
- Acronym / sponsor ID
- Tweet2Quit / 20141303
- Conditions
- Smoking Cessation
- Keywords
- Smoking, Social Media, Twitter, Behavior Change, Social Support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Stanford University, National Cancer Institute (NCI)
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tweet2Quit is an innovative smoking cessation intervention that combines real-time online peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Detailed description
The proposed randomized controlled evaluation of the Tweet2Quit intervention will biochemically verify abstinence out to 6-months follow-up and will test the personalized benefit for women of a women-only versus co-ed Tweet2Quit group. In a 3-arm design, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Each Tweet2Quit group will include buddy pairs based on similarity in demographics. Also automated pattern detection will identify dips in tweeting and trigger automated alerts and engagement strategies.
The sample consists of 960 adult smokers plus 20 in an initial pilot group to check technology functionality (not included in outcome assessment).
The primary aims test Hypothesis 1: Relative to usual care (n=240), Tweet2Quit-coed groups (n=480) will achieve significantly greater bioconfirmed sustained abstinence out to 6-months follow-up for each gender, and Hypothesis 2: Women in Tweet2Quit will achieve significantly greater bioconfirmed 6-months abstinence in woman-only groups (n=240) vs. coed groups (n=240 women).
Our secondary aims are to test the same hypotheses based on 3-month (end of treatment) sustained abstinence and 7-day point prevalence at 1, 3, and 6 months with biochemical verification at 3 and 6 months. Exploratory aims will study the Tweet2Quit groups' social network structures with a focus on the identification of buddy pairs and social brokers and test if these relationships are stronger for women in women-only groups versus women in coed groups of Tweet2Quit.
*Prior to the start of the RCT, the investigators will run one coed pilot group (N=20). Total size of the study (including the pilot group) will be N=980.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NRT + Web Guide | Active comparator | Drug: NRT, Behavioral: Web GuideNCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) |
| NRT + Web Guide + Tweet2Quit-Coed | Experimental | Drug: NRT, Behavioral: Web Guide, Behavioral: Tweet2QuitNCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group |
| NRT + Web Guide + Tweet2Quit-Women | Experimental | Drug: NRT, Behavioral: Web Guide, Behavioral: Tweet2QuitExperimental: NRT + Web Guide + Tweet2Quit-Women NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a women-only Tweet2Quit group |
| Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed) | Other | Drug: NRT, Behavioral: Web Guide, Behavioral: Tweet2QuitThe initial pilot group was run to check technology functionality and user acceptance; it was not included in outcome assessments. These participants received NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group. |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Are 21-59 years of age
- Are smoking 5+ cigarettes/day and 100+ cigarettes in one's lifetime
- In the preparation stage of quitting smoking
- Are English speaking
- Have a mobile phone with an unlimited texting plan and internet access (via mobile phone)
Key exclusion criteria (5 listed)
- Have certain medical conditions that are contraindicated for nicotine replacement therapy: pregnant, breast feeding, a recent heart attack, an irregular heartbeat, high blood pressure not controlled with medication, skin allergies to adhesive tape or serious skin problems, taking a prescription medicine for depression, and/or any other medical conditions that would prevent you from completing this study.
- Are an illicit hard drug user or regular marijuana user
- Share a household with someone else or has an immediate family member who has already enrolled in the study currently or in the past or if the participant has already been enrolled or failed to pass the screening once already since October 2016
- Participated in Tweet2Quit between 2012-2013 in a Twitter group and was not an active tweeter (<1 week)
- Fails to provide valid forms of all the required personal contact information
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 |
|---|---|---|
| NRTAlso: Nicotine Replacement Therapy8-weeks of study provided NRT patch, and 8-weeks of study provided NRT gum of varying strengths or 8-weeks of study provided NRT lozenges, depending on patient level of nicotine dependence. | Drug | Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed), NRT + Web Guide, NRT + Web Guide + Tweet2Quit-Coed, NRT + Web Guide + Tweet2Quit-Women |
| Web GuideA website that will provide participants with access to an evidence-based set of "base" treatment materials in one central location. The site will include information on the proper use of nicotine patches, gum, lozenges, and it will have a direct link for participants to access the NCI's Smokefree.gov Quit Guide. The website will remind participants about quit dates and send alerts via email to participants to complete the appropriate NCI Quit Guide modules. | Behavioural | Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed), NRT + Web Guide, NRT + Web Guide + Tweet2Quit-Coed, NRT + Web Guide + Tweet2Quit-Women |
| Tweet2QuitA fully automated, 90-day quit smoking intervention that provides an online, peer-to-peer support group for quitting and uses twice-daily automessages to encourage and direct the peer-to-peer exchanges. Each group will consist of 12 buddy pairs (matched on key demographics) that will be introduced via automated texts. The program will generate twice-daily programmed contacts (e.g., "what benefits do you hope to get from quitting smoking?"). Automated pattern detection software will identify and address any problematic low tweeting within a group. | Behavioural | Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed), NRT + Web Guide + Tweet2Quit-Coed, NRT + Web Guide + Tweet2Quit-Women |
Primary outcome
Percentage of Participants With a 6-month Sustained Abstinence
Time frame: 6 Month
Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times have you used e-cigs' since the quit date (assessed at 1, 3 and 6 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 and 6 months post quit date). Note: We will apply the Russell Standard for abstinence, allowing 5 or fewer instances of tobacco use over 6 months. In our primary (most rigorous) analysis, we will consider a cotinine-positive test, regardless of source, to be non-abstinent. In additional analyses, we will code as abstinent those who assert tobacco abstinence but continue use of FDA-approved nicotine replacement therapy. In other analyses we will report results with ENDS-only users coded first as non-abstinent and then for comparison as abstinent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32501274Pechmann C, Phillips C, Calder D, Prochaska JJ. Facebook Recruitment Using Zip Codes to Improve Diversity in Health Research: Longitudinal Observational Study. J Med Internet Res. 2020 Jun 5;22(6):e17554. doi: 10.2196/17554.
- Derived from this study: PubMed 31934869Pechmann CA, Calder D, Phillips C, Delucchi K, Prochaska JJ. The Use of Web-Based Support Groups Versus Usual Quit-Smoking Care for Men and Women Aged 21-59 Years: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jan 14;9(1):e16417. doi: 10.2196/16417.
- Please visit the Tweet2Quit Website to apply!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Connie (Cornelia) Pechmann, PhD, MBA, MS principal investigator
University of California, Irvine
Judith J Prochaska, PhD, MPH principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRT, Web Guide and Tweet2Quit in people with Smoking Cessation, run by University of California, Irvine at 2 sites 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 9 inclusion and 5 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With a 6-month Sustained Abstinence (time frame: 6 Month). 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 NCT02823028, which also lists 2 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 21 Nov 2024.