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

Sponsor
University of California, Irvine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02823028
Collaborator
Stanford University (Other), National Cancer Institute (NCI) (NIH)
960
2
3
71
480
6.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NRT
  • Behavioral: Web Guide
  • Behavioral: Tweet2Quit
Phase 2

Detailed Description

The proposed randomized controlled evaluation (N=960) 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 primary aims tests 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

Study Type:
Interventional
Actual Enrollment :
960 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Social Media Technology for Treating Tobacco Addiction
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with a 6-month sustained abstinence [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.

    Secondary Outcome Measures

    1. Percentage of participants with a 3-month sustained abstinence [3 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 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.

    Other Outcome Measures

    1. Percentage of participants with a 7-Day point prevalence abstinence [1 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 an e-cig' over the past 7 days (assessed at 1 month post quit date).

    2. Percentage of participants with a 7-Day point prevalence abstinence [3 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 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. Percentage of participants with a 7-Day point prevalence abstinence [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 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 59 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Irvine - Paul Merage School of Business Irvine California United States 92697
    2 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • University of California, Irvine
    • Stanford University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Connie (Cornelia) Pechmann, PhD, MBA, MS, University of California, Irvine
    • Principal Investigator: Judith J Prochaska, PhD, MPH, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cornelia Pechmann, Principle Investigator, University of California, Irvine
    ClinicalTrials.gov Identifier:
    NCT02823028
    Other Study ID Numbers:
    • R01CA204356 [HS# 2014-1303]
    • R01CA204356
    First Posted:
    Jul 6, 2016
    Last Update Posted:
    May 18, 2022
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Cornelia Pechmann, Principle Investigator, University of California, Irvine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022