EFFECT (electronic cigarettes vs. placebo)
Trial question
What is the role of nicotine-containing electronic cigarettes as smoking cessation aid?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 305
305 patients (173 female, 132 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 placebo (electronic cigarettes without nicotine plus placebo tablets BID for a total of 12 weeks).
Primary outcome
Confirmed abstinence at week 26
40.4%
19.7%
40.4 %
30.3 %
20.2 %
10.1 %
0.0 %
Electronic
cigarettes
Placebo
Significant
increase ▲
NNT = 4
Significant increase in confirmed abstinence at week 26 (40.4% vs. 19.7%; RD 20.7, 95% CI 10.4 to 30.4).
Secondary outcomes
Significant increase in self-reported abstinence at week 26 (43% vs. 22.4%; RD 20.6, 95% CI 10.1 to 30.5).
No significant difference in self-reported abstinence at week 52 (29.3% vs. 20.5%; RD 8.8, 95% CI -1 to 18.4).
No significant difference in confirmed abstinence at week 52 (28% vs. 19.9%; RD 8.1, 95% CI -1.6 to 17.6).
Conclusion
In participants aged 25-75 years who smoked daily and had volunteered to quit smoking, electronic cigarettes were superior to placebo 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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