Evidence map›Paper›PMID 37009114›Full record

ArticleFrontiers in psychiatry2023

A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol.

Randi M Schuster, Corinne Cather, Gladys N Pachas, Lindsay Nielsen, Vanessa Iroegbulem, Jason Dufour, Kevin Potter, Sharon Levy, Kevin M Gray, A Eden Evins

3 registry-linked trialsOpen access · goldFull text read
In one paragraph

Article in Frontiers in psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05367492 phase4completednot on this map

Randomized Controlled Trial of Varenicline for Cessation of Nicotine Vaping in Adolescent Non-smokers

TypeinterventionalSponsorMassachusetts General HospitalRan2022 to 2024Enrolled261ConditionsVaping, Nicotine DependenceArmsDouble Blind Varenicline, Double Blind Placebo, QuitVaping, This Is Quitting
NCT06115746 narecruitingnot on this map

A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students

TypeinterventionalSponsorMassachusetts General HospitalRan2023 to 2028Enrolled300ConditionsSubstance Use, Harm Reduction, Adolescent BehaviorArmsiDECIDE
NCT07223879 nanot yet recruitingnot on this mapstarted 2025, after this paper: background citation

Single Blind, Parallel Group Trial of Novel, On-Demand Virtual Reality to Amplify Practice Efficacy (NO VAPE) Added to Cognitive Behavioral Therapy for Nicotine Vaping Cessation

TypeinterventionalSponsorCharles River AnalyticsRan2025 to 2028Enrolled90ConditionsNO VAPE + 12 Weeks of Standard CBT, Sham NO VAPE + 12 Weeks Standard CBTArmsNO VAPE VR app with CBT-embedded content with a 12-session individual CBT treatment program, Sham VR app without CBT-embedded content with a 12-session individual CBT treatment program
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Interventions for quitting vaping.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Trial
  3. Novel Treatments for Adolescent Vaping Cessation: Are We There Yet?Journal of community hospital internal medicine perspectives · 2025
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Randi M SchusterDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Corinne CatherDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Gladys N PachasDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Lindsay NielsenDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Vanessa IroegbulemDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Jason DufourDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Kevin PotterDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Sharon LevyHarvard Medical School, Boston, MA, United States.
Kevin M GrayDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States.
A Eden EvinsDepartment of Psychiatry, Center of Addiction Medicine, Massachusetts General Hospital, Boston, MA, United States.
Massachusetts General Hospital · USHarvard University · USMedical University of South Carolina · US

Funding

Tulane NPRC SPF Sheltered Outdoor Enclosure ExpansionP51OD011104 · OD · TULANE UNIVERSITY OF LOUISIANA · PI L Lee HAMM · 2012 to 2026
$142.4M
Research Supplement to Promote Diversity in Health-Related Research: Randomized controlled trial of varenicline for cessation of nicotine vaping in adolescent non-smokersR01DA052583 · NIDA · MASSACHUSETTS GENERAL HOSPITAL · PI EVINS, A EDEN, SCHUSTER, RANDI MELISSA · 2021 to 2023
$2.2M
NIDA NIH HHS R01 DA052583NIH HHS P51 OD011104
6 · The paper itself

Abstract

Background: Approximately one-fifth of high-school seniors and college students currently vape nicotine. Adolescents express a desire to quit vaping, and case reports have shown promise for e-cigarette tapering with dual behavioral and pharmacologic therapies. However, there are no published clinical trials to date that test these intervention approaches for adolescent nicotine vaping cessation. In this three-arm randomized, placebo-controlled, parallel-group study, we aim to assess the efficacy of varenicline in combination with brief behavioral counseling and texting support on vaping cessation in adolescents dependent on vaped nicotine. Methods: The study will enroll 300 individuals between the ages of 16-25 with daily or near-daily nicotine vaping who reside in the Greater Boston area. Participants will be randomly assigned in a 1:1:1 ratio in blocks of six to one of the three arms: (1) a 12-week course of varenicline titrated to 1 mg bid, brief behavioral counseling delivered by a lay counselor, and an introduction to This is Quitting (TIQ) texting support created by the Truth Initiative; (2) a 12-week course of placebo, brief behavioral counseling, and TIQ; and (3) 12 weeks of enhanced usual care, consisting of advice to quit and an introduction to TIQ. The primary outcome will be biochemically verified continuous vaping abstinence at the end of the treatment (week 12). Secondary outcomes include continuous abstinence at follow-up (week 24), 7-day point prevalence abstinence at weeks 12 and 24, safety and tolerability of varenicline in an adolescent vaping population, as well as change in mood and nicotine withdrawal symptoms across the intervention period. Exploratory outcomes include change in comorbid substance use behaviors and nicotine dependence. Analysis will be intent-to-treat, with multiple imputation sensitivity analyses for participants with missing or incomplete outcome data. Discussion: This is the first study to evaluate varenicline in combination with a novel, brief, lay counselor delivered vaping cessation program for adolescents who vape nicotine. Results will inform clinicians on the effectiveness and acceptability of this promising, but not yet tested intervention.

Indexed as

adolescentscessationclinical triale-cigarettenicotinevapingvareniclineyoung adults

Identifiers

PMID37009114
PMCPMC10050714
OpenAlexW4324378500

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read34
identifiers read1
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.