NCT04251273

Brief Summary

This research study, conducted by Truth Initiative, will help us learn how text messaging can help young adults between 18 and 24 years of age quit vaping.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,588

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 19, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

February 14, 2023

Completed
Last Updated

July 10, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

January 23, 2020

Results QC Date

June 25, 2021

Last Update Submit

June 27, 2024

Conditions

Keywords

E-cigarette CessationVaping CessationMobile InterventionDigital Intervention

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT)

    Number of participant who responded "No" to the question "In the past 30 days, did you vape at all, even a puff of someone else's?" Denominator is all randomized participants.

    7 months post enrollment

Secondary Outcomes (3)

  • Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only)

    7 month post enrollment

  • Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT)

    7 months post enrollment

  • Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only)

    7 months post enrollment

Study Arms (2)

This is Quitting

EXPERIMENTAL

Participants will be enrolled to receive messages from This is Quitting. Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support.

Other: This is Quitting

Assessment only Control

OTHER

After an initial enrollment message, participants will be contacted periodically to assess e-cigarette use. At the end of the intervention period, they will receive information on how to sign up for This is Quitting if they are interested in the program

Other: Assessment only Control

Interventions

Text message-based intervention for quit vaping support.

This is Quitting

Assessment only

Assessment only Control

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-24
  • Past 30-day use of e-cigarettes containing nicotine
  • Interest in quitting e-cigarette use in the next 30 days
  • US residence

You may not qualify if:

  • Failure to confirm mobile number after initial sign-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Truth Initiative

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (4)

  • Graham AL, Jacobs MA, Amato MS, Cha S, Bottcher MM, Papandonatos GD. Effectiveness of a Quit Vaping Text Message Program in Promoting Abstinence Among Young Adult E-Cigarette Users: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 May 1;9(5):e18327. doi: 10.2196/18327.

    PMID: 32356774BACKGROUND
  • Graham AL, Cha S, Papandonatos GD, Amato MS, Jacobs MA, Abroms LC, Berg CJ. E-cigarette and combusted tobacco abstinence among young adults: Secondary analyses from a U.S.-based randomized controlled trial of vaping cessation. Prev Med. 2022 Dec;165(Pt B):107119. doi: 10.1016/j.ypmed.2022.107119. Epub 2022 Jun 28.

    PMID: 35777699BACKGROUND
  • Graham AL, Amato MS, Cha S, Jacobs MA, Bottcher MM, Papandonatos GD. Effectiveness of a Vaping Cessation Text Message Program Among Young Adult e-Cigarette Users: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jul 1;181(7):923-930. doi: 10.1001/jamainternmed.2021.1793.

  • Graham AL, Cha S, Do EK, Jacobs MA, Edwards G, Papandonatos GD. Dual abstinence from nicotine vaping and cannabis use among young people: secondary analyses from two U.S.-based randomized controlled trials of vaping cessation. Subst Abuse Treat Prev Policy. 2025 Nov 3;20(1):48. doi: 10.1186/s13011-025-00679-1.

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Amanda L. Graham, PhD, Principal Investigator
Organization
Truth Initiative

Study Officials

  • Amanda L Graham, PhD

    Truth Initiative

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are not explicitly told they are in the control group, although they may deduce their assignment from presence or lack of regular text message intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Innovations

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 31, 2020

Study Start

December 19, 2019

Primary Completion

November 12, 2020

Study Completion

November 12, 2020

Last Updated

July 10, 2024

Results First Posted

February 14, 2023

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

IPD are not available to other researchers. For access to deidentified dataset, please contact study administrator for more information.

Locations