A Novel Smartphone Application for Helping Teens Stop Vaping, QuitQuest Vaping R01

NCT07739706 | Not Yet Recruiting DMC

• 3 other identifiers: RG1126381NCI-2026-04135FHIRB0021244
• Study Type: interventional
• Target: 1,072
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial compares a novel smartphone application (app) called QuitQuest to the National Cancer Institute's (NCI's) SmokefreeTeenQuitVaping (SFTQV) app in helping teens stop vaping. Despite recent declines, data shows that 8.5% of middle school (grades 6-8) and 18.1% of high school (grades 9-12) students in the United States (US) used electronic nicotine delivery systems (ENDS; variously known as vaping, electronic \[e\]-cigarettes, e-cigs, mods, and tank systems that contain nicotine). Use of any tobacco product during adolescence increases risk for lifelong nicotine addiction. ENDS use, in particular, leads to severe asthma attacks, e-cigarette or vaping product use-associated lung injury (EVALI), exposure to multiple lung irritants, including volatile organic compounds, and lasting harm to adolescent brain development. Despite evidence of potential long-term harms from ENDS, to date there have been limited evidence-based therapeutic options for ENDS cessation for adolescents and young adults. Traditional methods for delivering adolescent ENDS cessation interventions (e.g., quitlines and clinics) have limited reach. QuitQuest utilizes Acceptance and Commitment Therapy (ACT), a psychological intervention that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies, to increase psychological flexibility, reduce distress, and promote behavior change through mechanisms that include cultivating acceptance of internal experience and aligning behavior with personal values. The SFTQV program is based on the US Clinical Practice Guidelines, offering practical advice and support via an app delivery format. The QuitQuest app may work better than the SFTQV app in increasing vape quit rates among teens.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• Self-reported 30-day point prevalence abstinence (PPA) from electronic nicotine delivery systems (ENDS) use

  Biochemical verification will be used to validate self-reported abstinence among participants who opt in at baseline and complete testing. In the primary intent-to-treat analysis, participants with missing 6-month self-reported outcome data will be classified as vaping. The primary missing=vaping outcome is based on self-reported 30-day ENDS use status, not on completion of biochemical verification. Participants who self-report abstinence but do not complete biochemical testing will not be automatically classified as vaping solely because biochemical verification is missing. The primary logistic regression model will adjust for the stratification factors used in randomization to appropriately account for study design, thereby improving the estimation of standard errors and increasing the validity of significance tests for the main treatment effect.

  At 6 months post-randomization

Secondary Outcomes (5)

• Self-reported 30-day PPA from ENDS use

  At 3 and 12 months post-randomization

• Self-reported 24-hour PPA from ENDS use

  At 3, 6, and 12 months post-randomization

• Self-reported 7-day PPA from ENDS use

  At 3, 6, and 12 months post-randomization

• Self-reported 30-day PPA from ENDS use

  At 3, 6, and 12 months post-randomization

• Biochemical verification of self-reported abstinence among participants who opt in at baseline and complete testing

  Up to 12 months post-randomization

Study Arms (2)

Arm I (QuitQuest app)

EXPERIMENTAL

Participants download and install the QuitQuest app for 12 months on study.

Behavioral: Smartphone Application-based Intervention; Other: Survey Administration; Other: Interview

Arm II (SFTQV app)

ACTIVE COMPARATOR

Participants utilize the NCI's SFTQV app for 12 months on study.

Behavioral: Smartphone Application-based Intervention; Other: Survey Administration; Other: Interview

Interventions

Survey Administration OTHER

Ancillary studies

Arm I (QuitQuest app); Arm II (SFTQV app)

Interview OTHER

Ancillary studies

Arm I (QuitQuest app); Arm II (SFTQV app)

Smartphone Application-based Intervention BEHAVIORAL

Use QuitQuest app

Also known as: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention

Arm I (QuitQuest app)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 13 to 17
• Used ENDS at least weekly in the past 30 days
• Wants to quit ENDS within the next 30 days
• If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days
• Interest in learning skills to quit ENDS
• Willing to be randomly assigned to either condition
• Resides in the United States (US) for the next 12 months
• Has daily access to their own smartphone
• Ability to download a smartphone app
• Able to read in English
• Not using other ENDS cessation interventions
• Have not participated in our prior studies
• No household or family member participating
• Willingness to complete survey and biochemical assessments at 3, 6, and 12 months
• Providing phone number(s), email, and mailing address

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jonathan Bricker, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Bricker, PhD

CONTACT

206-667-5074; jbricker@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The trial results data will be published in ClinicalTrials.gov at the time of study completion. The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
• Access Criteria: The de-identified scientific data will be available as public use data to the research community in openICPSR. Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads. No PII or PHI data will be shared or available for secondary use.

Locations

US (1)