Behavioral Intervention for Youth to Promote Vaping Cessation (VIA)

Mass General Brigham

Status: Not yet enrolling

Conditions: Nicotine Dependence; Vaping Teens; Vaping

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06765291

24-560

R01CA287721 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Up to 400 adolescents, ages 14-18, who vape, use electronic nicotine delivery systems at least weekly, and are willing to try to quit vaping will be enrolled; eligible participants will be randomly assigned in a 1:1 ratio to a double-blind intervention consisting of (1) QuitVaping intervention plus texting support or (2) EUC only. Participants assigned to the QuitVaping intervention will receive referral to TIQ texting app and 12 brief, weekly, study intervention visits with a 36-week follow up. Those who are assigned to EUC will be offered TIQ texting app referral to support vaping cessation. All participants will receive education about nicotine, vaping and addiction, advice to quit vaping, TIQ referral, and weekly blinded assessments with biochemical verification of abstinence. The person conducting the assessment will be blind to study condition such that the intervention will be double blind. Following completion of the 12-week intervention period, participants will have follow-up visits at weeks 16,20,24, 28, 32, and 36. Visits will be conducted remotely on a secure video conferencing platform or in-person. The enrollment visit will include a detailed description of the study, informed consent/assent, assessments to confirm eligibility, assessments of vaping and other drug use behavior, and medical and psychiatric diagnostic and symptom assessments. Eligible, consented participants will then be scheduled for weekly visits which will include assessments for all participants, and behavioral vaping cessation sessions for those assigned to QuitVaping. Saliva will be collected at assessment visits for cotinine measurement in participants who report nicotine abstinence as well as urine drug screening during study visits. Instructions for how to perform the tests will be sent to participants, and during virtual assessment visits, participants will hold the assays up to their device's camera so study staff can record the test results.

Enrollment: 400 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 14-18 inclusive
• Self-report of at least weekly nicotine vaping for the prior ≥3 months and semiquantitative saliva screening for cotinine positive for recent nicotine use
• Self-report of no regular combusted tobacco use (5 consecutive days of smoked tobacco use) in the 2 months prior to enrollment and exhaled CO <10 ppm
• Report willingness to try to quit 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 and willing to provide written informed consent (if under age 18)
• Competent and willing to provide written informed consent (if age 18) or assent (if under 18)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

QuitVaping (QV)

Experimental group

Description:

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

Treatment:

Behavioral: QuitVaping

Behavioral: This is Quitting (TIQ)

Enhanced Usual Care (EUC)

Active Comparator group

Description:

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

Treatment:

Behavioral: This is Quitting (TIQ)