QuitVaping for Nicotine Dependence

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Center for Addiction Medicine, Boston, MA
Nicotine Dependence+2 More
QuitVaping - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

The study will test the hypothesis that varenicline, when added to group behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus group behavioral and texting support for vaping cessation. Approximately 225 adolescents will be randomly assigned to one of three arms (1) varenicline up to 1 mg bid for 12 weeks plus behavioral and texting support for vaping cessation (2) identical appearing placebo plus behavioral and texting support and (3) monitoring only. The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.

Eligible Conditions

  • Nicotine Dependence
  • Vaping

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Nicotine Dependence

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Study weeks 9, 10, 11, 12, 16, 20, 24

Study week 12
Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment
Study week12
Continuous 4-week Nicotine Vaping Abstinence at end of treatment
Study weeks 1-12
Adverse Events
Change in General Distress
Change in Nicotine Withdrawal symptoms
Change in Vaping Craving (QVC)
Week 9
Continuous Nicotine Vaping Abstinence over Study Weeks 9 to 24

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Nicotine Dependence

Trial Design

3 Treatment Groups

Single Blind Monitoring only
1 of 3
Double Bline Varenicline
1 of 3
Double Blind Placebo
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

300 Total Participants · 3 Treatment Groups

Primary Treatment: QuitVaping · Has Placebo Group · Phase 4

Double Bline VareniclineExperimental Group · 3 Interventions: This Is Quitting, Double Blind Varenicline, QuitVaping · Intervention Types: Behavioral, Drug, Behavioral
Double Blind PlaceboPlaceboComparator Group · 3 Interventions: This Is Quitting, Double Blind Placebo, QuitVaping · Intervention Types: Behavioral, Drug, Behavioral
Single Blind Monitoring onlyNoIntervention Group · 1 Intervention: Single Blind Monitoring only · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: study weeks 9, 10, 11, 12, 16, 20, 24
Closest Location: Center for Addiction Medicine · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2022First Recorded Clinical Trial
2 TrialsResearching Nicotine Dependence
1 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,201 Previous Clinical Trials
5,609,854 Total Patients Enrolled
117 Trials studying Nicotine Dependence
18,414 Patients Enrolled for Nicotine Dependence
Massachusetts General HospitalLead Sponsor
2,660 Previous Clinical Trials
30,828,497 Total Patients Enrolled
8 Trials studying Nicotine Dependence
934 Patients Enrolled for Nicotine Dependence
Eden Evins, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Nicotine Dependence
4 Patients Enrolled for Nicotine Dependence
Randi Schuster, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Nicotine Dependence
4 Patients Enrolled for Nicotine Dependence

Eligibility Criteria

Age < 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Self-report of no regular combusted tobacco use in the past 2 months at enrollment and exhaled CO <10 ppm.
You are an eligible candidate for the study if you are ages 16-25, inclusive.
You are 35 kilograms (77 pounds) or less than 35 kilograms (77 pounds) in body mass index (BMI).
You are able to understand study procedures and read and write in English.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.