NCT02823028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
980

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

5.9 years

First QC Date

June 16, 2016

Results QC Date

August 24, 2024

Last Update Submit

November 14, 2024

Conditions

Keywords

SmokingSocial MediaTwitterBehavior ChangeSocial Support

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

NRT + Web Guide

ACTIVE COMPARATOR

NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges)

Drug: NRTBehavioral: Web Guide

NRT + Web Guide + Tweet2Quit-Coed

EXPERIMENTAL

NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group

Drug: NRTBehavioral: Web GuideBehavioral: Tweet2Quit

NRT + Web Guide + Tweet2Quit-Women

EXPERIMENTAL

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: NRTBehavioral: Web GuideBehavioral: Tweet2Quit

Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)

OTHER

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: NRTBehavioral: Web GuideBehavioral: Tweet2Quit

Interventions

NRTDRUG

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.

Also known as: Nicotine Replacement Therapy
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)NRT + Web GuideNRT + Web Guide + Tweet2Quit-CoedNRT + Web Guide + Tweet2Quit-Women
Web GuideBEHAVIORAL

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.

Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)NRT + Web GuideNRT + Web Guide + Tweet2Quit-CoedNRT + Web Guide + Tweet2Quit-Women
Tweet2QuitBEHAVIORAL

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.

Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)NRT + Web Guide + Tweet2Quit-CoedNRT + Web Guide + Tweet2Quit-Women

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Irvine - Paul Merage School of Business

Irvine, California, 92697, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Professor Cornelia Pechmann
Organization
University of California Irvine

Study Officials

  • Connie (Cornelia) Pechmann, PhD, MBA, MS

    University of California, Irvine

    PRINCIPAL INVESTIGATOR
  • Judith J Prochaska, PhD, MPH

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 16, 2016

First Posted

July 6, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

November 21, 2024

Results First Posted

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations