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

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: NRT; Behavioral: Web Guide; Behavioral: Tweet2Quit

• Registration Number: NCT02823028
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-06
• Study Start: 2016-10
• Primary Completion: 2022-09
• Study Completion: 2022-09
• Results First Submitted: 2024-08-24
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 980

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NRT + Web Guide	NRT	NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges)
NRT + Web Guide	Web Guide	NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges)
NRT + Web Guide + Tweet2Quit-Coed	NRT	NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group
NRT + Web Guide + Tweet2Quit-Coed	Web Guide	NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group
NRT + Web Guide + Tweet2Quit-Coed	Tweet2Quit	NCI 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	NRT	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
NRT + Web Guide + Tweet2Quit-Women	Web Guide	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
NRT + Web Guide + Tweet2Quit-Women	Tweet2Quit	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
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)	NRT	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.
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)	Web Guide	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.
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)	Tweet2Quit	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

University of California, Irvine - Paul Merage School of Business; 🇺🇸 Irvine, California, United States