Behavioral Intervention for Youth to Promote Vaping Cessation

NCT06765291 | Recruiting DMC

• 2 other identifiers: 24-560R01CA287721
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the hypothesis that the QuitVaping (QV) intervention and additional texting support will improve nicotine abstinence rates in adolescents as compared to Enhanced Usual Care (EUC: education about nicotine, vaping and addiction, advice to quit vaping, referral to TIQ texting support). Approximately 400 adolescents will be randomly assigned to one of two arms (1) QuitVaping intervention plus texting support to quit vaping and (2) EUC only.

Conditions

Vaping; Vaping Teens; Nicotine Dependence

Keywords

Vaping; Nicotine Depedence; Vaping Cessation

Outcome Measures

Primary Outcomes (1)

• Continuous 4-week nicotine vaping abstinence at end of treatment

  The percent of participants who self-report nicotine vaping abstinence since the last visit on the timeline followback interview and have cotinine \<10ng/mL, assessed at study weeks 9-12. The primary comparison of interest is between the QV + EUC arms.

  From week 9 to week 12

Secondary Outcomes (1)

• Continuous continine-verified nicotine vaping abstinence at the end of follow up (Weeks 9-36)

  From week 9 to week 36

Study Arms (2)

QuitVaping (QV)

EXPERIMENTAL

Participants will: * Attend QuitVaping behavioral support sessions, completed via videoconference or in-person, once per week for 12 weeks * Be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents

Behavioral: QuitVaping; Behavioral: This is Quitting (TIQ)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Participants will: * Be encouraged to sign up for This is Quitting (TIQ), a text message vaping cessation program for adolescents * Attend no behavioral support sessions

Behavioral: This is Quitting (TIQ)

Interventions

QuitVaping BEHAVIORAL

QuitVaping is a manualized intervention based on the American Lung Association smoking cessation program modified with adolescent appropriate content and language for vaping cessation from the vaping section of teen.smokefree.gov and the Truth Initiative. These behavioral support sessions will be delivered weekly during the 12-week treatment phase via videoconference or in- person.

QuitVaping (QV)

This is Quitting (TIQ) BEHAVIORAL

A free, publicly available text message vaping cessation program from Truth Initiative, designed specifically to help adolescents who vape nicotine quit. Participants who set a quit date receive messages for a week preceding it and 30 days 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.

Enhanced Usual Care (EUC); QuitVaping (QV)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14-18 inclusive
• Self-report of at least weekly nicotine vaping (or use of other non combusted nicotine products, "vaping") for the prior ≥3 months
• Self-report of no regular combusted tobacco use (i.e., 5 or more days of smoke smoked tobacco use per week) prior to enrollment and exhaled CO \<10 ppm for those with an in person baseline visit
• Report willingness to try to quit or reduce vaping in the next 30 days
• Able to understand study procedures and read and write in English or Spanish
• Have a parent or legal guardian who is able to participate in the opt out process
• Competent and willing to provide written informed consent (if age 18) or assent (if under 18)

You may not qualify if:

• Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion)
• Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study
• Unwilling to provide saliva or urine samples
• Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Vaping; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• A. Eden Evins, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Randi M. Schuster, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A. Eden Evins, MD, MPH

CONTACT

617-643-4679; aeevins@mgh.harvard.edu

Julia Jashinski, MSW

CONTACT

617-643-1984; jjashinski@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): March 29, 2028
• Study Completion (Estimated): September 27, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Scientific data will be available one year after the grant end date specified on the first Notice of Award. Scientific data included in published manuscripts will be made available at the time of publication. Scientific data and the code/software/tools used to development the published or submitted dataset will be shared at the time of data submission or publication and maintained for no shorter than five years.
• Access Criteria: Data access will be controlled. In order to access shared data, qualified researchers will be required to complete a data use certification and receive approval from NDA Data Access Committee.

Locations

US (1)