Twitter-enabled Mobile Messaging for Smoking Relapse Prevention (Tweet2Quit) (Tweet2Quit)

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: NRT; Behavioral: Web Guide; Behavioral: Tweet2Quit

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 Type: Interventional
• Enrollment (Actual): 980
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine - Paul Merage School of Business
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• Are a social media user
• Have an active email account
• Lives in the continental USA

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NRT + Web Guide; NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges)	Drug: NRT; 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.; Other Names: Nicotine Replacement Therapy; Behavioral: Web Guide; 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.
Experimental: NRT + Web Guide + Tweet2Quit-Coed; NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group	Drug: NRT; 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.; Other Names: Nicotine Replacement Therapy; Behavioral: Web Guide; 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.; Behavioral: Tweet2Quit; 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.
Experimental: NRT + Web Guide + Tweet2Quit-Women; 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	Drug: NRT; 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.; Other Names: Nicotine Replacement Therapy; Behavioral: Web Guide; 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.; Behavioral: Tweet2Quit; 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.
Other: Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed); 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.	Drug: NRT; 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.; Other Names: Nicotine Replacement Therapy; Behavioral: Web Guide; 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.; Behavioral: Tweet2Quit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with a 3-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 an e-cig' since the quit date (assessed at 1 and 3 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 months post quit date). Note: We will apply the Russell Standard for abstinence, allowing 5 or fewer instances of tobacco use over 3 months.	3 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with a 7-Day point prevalence 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 an e-cig' over the past 7 days (assessed at 1 month post quit date).	1 Month
Percentage of participants with a 7-Day point prevalence 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 did you use an e-cig' over the past 7 days (assessed at 3 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 months post quit date). A result level of 0 (0-10ng/ml) will be considered abstinent. Additionally if the participant reports living with a heavy smoker, then a result of 1 (10-30ng/ml) or lower will be considered abstinent.	3 Month
Percentage of participants with a 7-Day point prevalence 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 did you use an e-cig' over the past 7 days (assessed at 6 months post quit date) confirmed by salivary cotinine measurement (assessed at 6 months post quit date). If participants report abstinence on the 6-month survey they will be given a saliva test to bioconfirm their abstinence. A result level of 0 (0-10ng/ml) will be considered abstinent. Additionally if the participant reports living with a heavy smoker, then a result of 1 (10-30ng/ml) or lower will be considered abstinent.	6 Month

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Cancer Institute (NCI); Stanford University
• Investigators: Principal Investigator: Judith J Prochaska, PhD, MPH, Stanford University; Principal Investigator: Connie (Cornelia) Pechmann, PhD, MBA, MS, University of California, Irvine

Publications and helpful links

General 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.
• Pechmann 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.

Helpful Links

• Please visit the Tweet2Quit Website to apply!

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimated): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Smoking; Behavior Change; Social Support; Social Media; Twitter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20141303; R01CA204356 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No