Grand Rounds August 8, 2025: Youth Nicotine Vaping Cessation: RCT of Varenicline Added to Remote Young Adult Lay Counselor Delivered Behavioral Cessation Support Vs. Texting Support (A. Eden Evins, MD, MPH)

Speaker

A. Eden Evins, MD, MPH
Cox Family Professor of Psychiatry, Harvard Medical School
Founding Director, MGH Center for Addiction Medicine
Director for Faculty Development, Mass General Hospital Department of Psychiatry

Keywords

Vaping; Nicotine; Cessation; Behavioral Support; Texting

Key Points

  • Vaping, though technically a less harmful alternative to cigarette smoking, is the primary route to nicotine addiction in youth. Initially promoted to help with smoking cessation, vaping devices are increasingly marketed towards young people and have transformed teen nicotine and cannabis use.
  • Few treatments for vaping cessation have been tested. The research team hypothesized that the pharmacotherapy varenicline could help young adults abstain from nicotine vaping.
  • They conducted a randomized clinical trial with 2 aims: evaluate the efficacy of varenicline in addition to behavioral support for cessation of vaped nicotine and assess the safety and tolerability of varenicline. The target population was adolescents attempting vaping cessation.
  • According to the original design, participants would be randomized to 1 of 2 arms: varenicline + behavioral therapy and placebo + behavioral therapy. The possibility arose that the behavioral intervention would be particularly effective, they wouldn’t be able to differentiate between the arms, and the trial would fail. So they added a third arm: a referral to a widely-available messaging app supporting youth vaping cessation.
  • The research team made a few additional modifications to cut costs and enhance adherence. These included fully remote intervention and assessment; non-clinical personnel delivering the behavioral interventions; and video documentation of adherence, with compensation of $1 per video.
  • Over half of participants offered varenicline + counseling quit vaping and were abstinent for the last 4 weeks of treatment. The 4-week abstinence rate was 14% in the placebo + counseling group and 6% in the group that received texting support.
  • The study had a 97% completion rate using remote methods for intervention delivery and data collection. The research team received video evidence for 52% of varenicline doses and 42% of placebo doses. Behavioral counseling attendance was higher in the varenicline group (84%) than in the placebo group (66%).
  • Nausea, vivid dreams, and insomnia were more common in the group that received varenicline.

Discussion Themes

There’s interest in testing the effectiveness of varenicline without the addition of behavioral support. It’s an important question, Dr. Evins noted, given that behavioral support can be hard to come by.

Varenicline has been associated with exacerbation of psychiatric symptoms, including suicidal ideation. However, this has not been replicated in large clinical trials or epidemiologic trials. Explanations for the association include the effects of nicotine withdrawal symptom or the manifestation of comorbid psychiatric illnesses.