ViVA (varenicline vs. placebo)
Trial question
What is the effect of varenicline in young adults who vape nicotine and do not regularly smoke tobacco?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 175
175 patients (93 female, 82 male).
Inclusion criteria: young adults, aged 16-25 years, who vape nicotine daily or near daily and do not regularly smoke tobacco.
Key exclusion criteria: smoking cessation pharmacotherapy use in the prior month; inpatient psychiatric hospitalization; suicide attempt; other unstable medical condition in the prior 6 months.
Interventions
N=88 varenicline (varenicline titrated to 1 mg BID over 7 days, behavioral counseling, and text messaging support over 12 weeks).
N=87 placebo (matching placebo, behavioral counseling, and text messaging support over 12 weeks).
Primary outcome
Rate of biochemically verified continuous vaping abstinence during weeks 9-12
51%
14%
51.0 %
38.3 %
25.5 %
12.8 %
0.0 %
Varenicline
Placebo
Significant
increase ▲
NNT = 2
Significant increase in the rate of biochemically verified continuous vaping abstinence during weeks 9-12 (51% vs. 14%; OR 6.5, 95% CI 3 to 14.1).
Secondary outcomes
Significant increase in the rate of continuous vaping abstinence during weeks 9-24 (28% vs. 7%; OR 6, 95% CI 2.1 to 16.9).
Significant increase in point prevalence abstinence at week 12 (68% vs. 25%; OR 6.1, 95% CI 3.1 to 12.2).
Safety outcomes
No significant differences in treatment-emergent adverse event, serious adverse event.
Conclusion
In young adults, aged 16-25 years, who vape nicotine daily or near daily and do not regularly smoke tobacco, varenicline was superior to placebo with respect to the rate of biochemically verified continuous vaping abstinence during weeks 9-12.
Reference
A Eden Evins, Corinne Cather, Harrison T Reeder et al. Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial. JAMA. 2025 Apr 23:e253810. Online ahead of print.
Open reference URL