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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02823028
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : March 29, 2021
Sponsor:
Collaborators:
Stanford University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cornelia Pechmann, University of California, Irvine

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
Smoking Cessation 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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Percentage of participants with a 3-month sustained abstinence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823028


Locations
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United States, California
University of California, Irvine - Paul Merage School of Business
Irvine, California, United States, 92697
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
University of California, Irvine
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Connie (Cornelia) Pechmann, PhD, MBA, MS University of California, Irvine
Principal Investigator: Judith J Prochaska, PhD, MPH Stanford University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cornelia Pechmann, Principle Investigator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02823028    
Other Study ID Numbers: R01CA204356 [HS# 2014-1303]
R01CA204356 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cornelia Pechmann, University of California, Irvine:
Smoking
Social Media
Twitter
Behavior Change
Social Support
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action