Clinical trial NCT06765291: Behavioral Intervention for Youth to Promote Vaping Cessation
Official title: Behavioral Intervention for Youth to Promote Vaping Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaping
Vaping Teens
Nicotine Dependence
Keywords: Vaping
Nicotine Depedence
Vaping Cessation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous 4-week nicotine vaping abstinence at end of treatment
timeFrame: From week 9 to week 12
Secondary outcomes:
measure: Continuous continine-verified nicotine vaping abstinence at the end of follow up (Weeks 9-36)
timeFrame: From week 9 to week 36
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: A. Eden Evins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Randi M. Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References: