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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02823028
Other study ID # R01CA204356 [HS# 2014-1303]
Secondary ID R01CA204356
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2016
Est. completion date September 2022

Study information

Verified date May 2023
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 960
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 59 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
United States University of California, Irvine - Paul Merage School of Business Irvine California
United States Stanford University School of Medicine Stanford California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Irvine National Cancer Institute (NCI), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Primary 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 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
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