Phase 4
N=261
Varenicline for Nicotine Vaping Cessation in Adolescents
Vaping · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT05367492 ↗Enrolled (actual)
261
Serious AEs
1.9%
Results posted
Apr 2025
Primary outcome: Primary: Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12) — 45; 12; 5 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Double Blind Varenicline (Drug); Double Blind Placebo (Drug); QuitVaping (Behavioral); This Is Quitting (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous 4-week Nicotine Vaping Abstinence at End of Treatment (Weeks 9-12) |
45; 12; 5 | <0.001 sig |
| SECONDARY Seven-Day Point-Prevalence Nicotine Vaping Abstinence at End of Treatment (Week 12) |
60; 22; 13 | <0.001 sig |
| SECONDARY Continuous Nicotine Vaping Abstinence Over Study Weeks 9 to 24 |
25; 6; 3 | 0.001 sig |
| SECONDARY Minnesota Nicotine Withdrawal Scale (MNWS) Total Score (Weeks 1-12) |
8.7; 10.6; 10.4; 9.2; 10.6; 10.0 | 0.001 sig |
| SECONDARY Questionnaire of Vaping Craving (QVC) Total Scores (Weeks 1-12) |
34.1; 39; 37; 29; 37.3; 36.6 | <0.001 sig |
| SECONDARY Mood and Anxiety Symptoms Questionnaire (MASQ-D30) General Distress Subscore (Weeks 4, 8, and 12) |
15.8; 19; 17.9; 15.6; 16.9; 16.9 | 0.008 sig |
| SECONDARY Neuropsychiatric Adverse Event Inventory (NAEI) Elicited Adverse Events by Week 12 |
71; 61; 78 | 0.16 |
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.
Eligibility Criteria
Inclusion Criteria
- Ages 16-25, inclusive;
- Self-report of daily or near daily nicotine vaping for the prior ≥ 3 months and semi-quantitative saliva screening for cotinine positive for recent nicotine use;
- Nicotine dependence as defined by a score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI), or report of persistent use despite negative consequences, or prior failed quit attempts;
- Self-report of no regular combusted tobacco use in the past 2 months at enrollment and exhaled CO <10 ppm;
- Total body weight at enrollment ≥35 kg (77 lbs);
- Report willingness to try varenicline to stop vaping;
- Able to understand study procedures and read and write in English;
- Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
- Competent and willing to provide written informed consent (if age 18+) or assent (if under 18);
- For participants who could become pregnant: negative urine pregnancy test at enrollment and agree to use effective contraception (e.g., abstinence, hormonal contraception, intra-uterine device, sterilization, or double barrier contraception) during the study.
Exclusion Criteria
- Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
- Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
- Unstable medical condition, epilepsy, severe renal impairment;
- Inpatient psychiatric hospitalization in the prior 6 months, serious suicidal ideation or suicide attempt within 6 months of enrollment, recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
- Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion;
- Prior adverse drug reaction to varenicline;
- Unwilling to provide urine samples;
- Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol;
- Ward of the state.
Data sourced from ClinicalTrials.gov (NCT05367492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.