EFFECT (electronic cigarettes vs. varenicline)
Trial question
Are nicotine-containing electronic cigarettes superior to varenicline as smoking cessation aid?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 305
305 patients (167 female, 138 male).
Inclusion criteria: participants aged 25-75 years who smoked daily and had volunteered to quit smoking.
Key exclusion criteria: pregnancy; use of smoking cessation pharmacotherapy or electronic cigarettes during the past year; cancer; ischemic vascular or heart disease; recent MI in the past 3 months; hypertension.
Interventions
N=152 electronic cigarettes (nicotine-containing electronic cigarettes plus placebo tablets BID for a total of 12 weeks).
N=153 varenicline (electronic cigarettes without nicotine plus varenicline 0.5-1 mg tablets BID for a total of 12 weeks).
Primary outcome
Confirmed abstinence at week 26
40.4%
43.8%
43.8 %
32.8 %
21.9 %
10.9 %
0.0 %
Electronic
cigarettes
Varenicline
No significant
difference ↔
No significant difference in confirmed abstinence at week 26 (40.4% vs. 43.8%; RD -3.4, 95% CI -14.3 to 7.6).
Secondary outcomes
No significant difference in self-reported abstinence at week 26 (43% vs. 45.1%; RD -2.1, 95% CI -13.1 to 9).
Significant decrease in self-reported abstinence at week 52 (29.3% vs. 39.2%; RD -9.9, 95% CI -20.3 to 0.8).
Significant decrease in confirmed abstinence at week 52 (28% vs. 37.9%; RD -9.9, 95% CI -20.2 to 0.7).
Conclusion
In participants aged 25-75 years who smoked daily and had volunteered to quit smoking, electronic cigarettes were not superior to varenicline with respect to confirmed abstinence at week 26.
Reference
Anna Tuisku, Mikko Rahkola, Pentti Nieminen et al. Electronic Cigarettes vs Varenicline for Smoking Cessation in Adults: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jun 17:e241822.
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