Behavioral Intervention for Youth to Promote Vaping Cessation

Not Applicable

Not yet recruiting

• Conditions: Vaping; Vaping Teens; Nicotine Dependence

• Registration Number: NCT06765291
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-03
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Study Start: 2025-03
• Primary Completion: 2028-07
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Continuous 4-week nicotine vaping abstinence at end of treatment	From week 9 to week 12	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.

Secondary Outcome Measures

Name	Time	Method
Continuous continine-verified nicotine vaping abstinence at the end of follow up (Weeks 9-36)	From week 9 to week 36	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 9-36. The primary comparison of interest is between the QV + EUC arms.

Trial Locations

Locations (1)

Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114; 🇺🇸 Boston, Massachusetts, United States