Varenicline for Nicotine Vaping Cessation in Adolescents

Summary

The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus 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 (V+BC), (2) identical appearing placebo plus behavioral and texting support (P+BC) and (3) enhanced usual care (EUC). The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.

Conditions

• Vaping
• Nicotine Dependence

Interventions

DRUG

Double Blind Varenicline

For participants 16-17 years old, ≤ 55 kg: * 0.5 mg once daily for 7 days, then * 0.5 mg twice daily for 11 weeks For participants 16-17 years old, \>55 kg: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks For participants 18+ years old: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks

DRUG

Double Blind Placebo

For participants 16-17 years old, ≤ 55 kg: * 0.5 mg once daily for 7 days, then * 0.5 mg twice daily for 11 weeks For participants 16-17 years old, \>55 kg: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks For participants 18+ years old, regardless of weight: * 0.5 mg once daily or 3 days, * 0.5 mg twice daily for 4 days * 1.0 mg twice daily for 11 weeks

BEHAVIORAL

QuitVaping

QuitVaping is a manualized intervention based on the American Lung Association smoking cessation program modified with adolescent appropriate content and language for vaping cessation from the vaping section of teen.smokefree.gov and the Truth Initiative. These behavioral support sessions will be delivered weekly during the 12-week treatment phase via videoconference or in- person.

BEHAVIORAL

This Is Quitting

A free, publicly available text message vaping cessation program from Truth Initiative, designed specifically to help adolescents who vape nicotine quit. Participants who set a quit date receive messages for a week preceding it and 30 days afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting and cutting down to quit.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Eden Evins, MD · Massachusetts General Hospital

• Randi Schuster, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-22

Primary Completion

2024-03-20

Completion

2024-05-28

FDA Drug

Yes

Countries

• United States

Study Locations