VANISH (tobacco use)
Trial question
What is the role of a combination of varenicline and nicotine replacement therapy in hospitalized adult daily smokers?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 320
320 patients (137 female, 183 male).
Inclusion criteria: adult inpatients with a history of smoking ≥ 10 cigarettes/day who were interested in quitting.
Key exclusion criteria: no informed consent; smoked < 10 cigarettes/day; pregnancy/breastfeeding; terminal illness; unstable cardiovascular status; new diagnosis of major psychiatric illness.
Interventions
N=160 NRT plus varenicline (nicotine replacement therapy 2 mg plus varenicline regimen for 12 weeks).
N=160 placebo plus varenicline (matching placebo lozenges plus varenicline regimen for 12 weeks).
Primary outcome
Biochemically verified sustained abstinence at 6 months
11.4%
10.1%
11.4 %
8.6 %
5.7 %
2.9 %
0.0 %
NRT plus
varenicline
Placebo plus
varenicline
No significant
difference ↔
No significant difference in biochemically verified sustained abstinence at 6 months (11.4% vs. 10.1%; OR 1.14, 95% CI 0.56 to 2.33).
Secondary outcomes
Significant increase in self-reported prolonged abstinence at 3 months (44.3% vs. 32.7%; OR 1.64, 95% CI 1.04 to 2.59).
Significant increase in self-reported 7-day point prevalence abstinence at 6 months (34.2% vs. 23.4%; OR 1.71, 95% CI 1.04 to 2.8).
Significant increase in self-reported prolonged abstinence at 12 months (29.9% vs. 19.1%; OR 1.77, 95% CI 1.05 to 3).
Safety outcomes
No significant difference in drug-related adverse events.
Conclusion
In adult inpatients with a history of smoking ≥ 10 cigarettes/day who were interested in quitting, NRT plus varenicline was not superior to placebo plus varenicline with respect to biochemically verified sustained abstinence at 6 months.
Reference
Gregory R Weeks, Rukshar K Gobarani, Michael J Abramson et al. Varenicline and Nicotine Replacement Therapy for Smokers Admitted to Hospitals: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2418120.
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