Actively Recruiting

Phase Not Applicable
Age: 14Years - 18Years
All Genders
ID06765291

Behavioral Intervention for Youth to Promote Vaping Cessation

Led by Massachusetts General Hospital · Updated on 2025-10-22

400

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether the QuitVaping (QV) behavioral support intervention combined with additional texting help improves nicotine abstinence rates among adolescents aged 14 to 18 who vape nicotine weekly or use other non-combusted nicotine products. This trial compares the QuitVaping intervention plus texting support to Enhanced Usual Care (EUC), which includes education, quitting advice, and referral to a texting support program. About 400 adolescents will be randomly assigned to one of the two groups to test this approach for vaping cessation. Participants in the QuitVaping group will attend 12 weekly behavioral support sessions delivered via videoconference or in person and will be encouraged to sign up for the This is Quitting (TIQ) texting program. Those in the EUC group will receive education and advice about vaping, plus referral to the TIQ texting program but will not attend behavioral support sessions. After the 12-week intervention phase, all participants will have monthly follow-up visits up to week 36. Assessments will be conducted remotely or in person. During the study, participants will complete weekly assessments including biochemical verification of nicotine abstinence through saliva cotinine tests and urine NNAL tests for those reporting sustained abstinence near week 12. The initial enrollment visit includes informed consent or assent, eligibility confirmation, and assessments of vaping behavior and medical history. The main outcome measured is continuous 4-week nicotine vaping abstinence at weeks 9 to 12. Safety and abstinence will be monitored throughout the study lasting up to 36 weeks.

CONDITIONS

Brief Title

Behavioral Intervention for Youth to Promote Vaping Cessation

Who Can Participate

Age: 14Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 to 18 years inclusive
  • Self-report of at least weekly nicotine vaping or use of other non-combusted nicotine products for at least 3 months
  • No regular use of smoked tobacco (less than 5 days per week) before enrollment and exhaled CO less than 10 ppm for in-person visits
  • Willingness to try to quit or reduce vaping within the next 30 days
  • Ability to understand study procedures and read and write in English or Spanish
  • Have a parent or legal guardian able to participate in the opt-out process
  • Competent and willing to provide written informed consent (if 18) or assent (if under 18)
Not Eligible

You will not qualify if you...

  • Use of smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, inhaler, varenicline, bupropion)
  • Unwillingness to abstain from other smoking cessation aids during the study except those provided by the study
  • Unwillingness to provide saliva or urine samples
  • Any condition or situation that would make safe and compliant participation unlikely according to the investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or remote)

Outpatient Treatment

Duration - 12 weeks

Participants receive behavioral support sessions if assigned to QuitVaping, along with weekly assessments and encouragement to use a text message vaping cessation program. Participants assigned to Enhanced Usual Care receive weekly assessments and encouragement to use the text message program without behavioral support sessions.

Weekly visits (remote or in-person)

Follow-up

Duration - Weeks 16 to 36

Participants have monthly follow-up visits to assess vaping abstinence and support continued cessation efforts, conducted remotely or in-person.

6 monthly visits (remote or in-person)

Trial Site Locations

Total: 1 location

1

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

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

A. Eden Evins, MD, MPH

J

Julia Jashinski, MSW

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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