Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05367492 · ClinicalTrials.gov registry record · Phase 4
Varenicline for Nicotine Vaping Cessation in Adolescents
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 261
- Enrollment target
NCT05367492: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT05367492 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 261 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05367492, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 261 participants
- Enrollment target
Study 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.
Primary Outcome
Point-prevalence abstinence from e-cigarette use was defined as self-report of no e-cigarette use since the last visit, bioverified by saliva cotinine \<30 ng/ml. Continuous abstinence is defined as observed point-prevalence abstinence over specified study visits at weeks 9, 10, 11 and 12. Visits with self-reported abstinence missing bioverification were treated as missing, with missingness addressed via multiple imputation.
Interventions
- BEHAVIORAL QuitVaping
- DRUG Double Blind Placebo
- DRUG Double Blind Varenicline
- BEHAVIORAL This Is Quitting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 4 |
What the finished NCT05367492 record still lists
NCT05367492 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which QuitVaping is the first listed.
NCT05367492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05367492 about?
NCT05367492 is a clinical study titled "Varenicline for Nicotine Vaping Cessation in Adolescents". 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...
What is the current status of trial NCT05367492?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 261 participants. The study started on 2022-06-22. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT05367492?
The interventions under investigation include: QuitVaping (BEHAVIORAL), Double Blind Placebo (DRUG), Double Blind Varenicline (DRUG), This Is Quitting (BEHAVIORAL).
Who is sponsoring clinical trial NCT05367492?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05367492's enrollment target sits among peer trials
261 326th of 2000 higher than 1,675 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05124912 · 261 participants · NA
REMASTer: REcurrent Brain Metastases After SRS Trial
- NCT06559891 · 261 participants · NA
THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension
- NCT03713268 · 262 participants
Intraoperative OCT Guidance of Intraocular Surgery II
- NCT06074380 · 262 participants · Phase 4
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI