Evicenter
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Cytisinicline

Smoking cessation

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86 sources

Clinical evidence

SMILE

10 evidence topics · 1 source

Objective
Smoking-cessation objective

“smoking cessation” (opens the source at this quote in a new tab)

Location and study date
Country

“Italy” (opens the source at this quote in a new tab)

Study design
Trial setting and design

“single-center, randomized, controlled trial” (opens the source at this quote in a new tab)

Eligibility criteria
Screening population

“current heavy tobacco users” (opens the source at this quote in a new tab)

Treatment
Concomitant intervention

“counseling” (opens the source at this quote in a new tab)

Study outcomes
Rationale for using continuous smoking abstinence as the primary endpoint
Primary outcome
CharacteristicQuoted value
Continuous-abstinence assessment“12 months”
Statistical analysis description
Number of participants (Planned and analyzed)
Randomized population
CharacteristicQuoted value
Total“869”
Cytisine plus counseling“470”
Counseling alone“399”
Description of analysis sets

No evidence found.

Results
Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results
Biochemically verified continuous abstinence
CharacteristicQuoted value
Cytisine plus counseling“32.1%”
Counseling alone“7.3%”
Adjusted odds ratio“7.2”
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results
Participants reporting adverse events
CharacteristicQuoted value
Cytisine group“196”
Control group“133”
Study limitations
Summary

This single-center trial enrolled current heavy smokers in lung-cancer screening. Its control was counseling alone rather than placebo tablets or an active cessation medication. Applicability to other smoking populations and comparative tolerability against active medication remain uncertain.