This document describes a randomized controlled trial that compared the effectiveness of cytisine versus nicotine replacement therapy (NRT) for smoking cessation. The trial involved 1310 daily smokers who were randomly assigned to receive either a 25-day course of cytisine tablets or 8 weeks of NRT products like patches and gum. The primary outcome was continuous abstinence since the quit date, which was assessed at 1 week and 1, 2, and 6 months post-quit. Baseline characteristics were similar between the cytisine and NRT groups. The trial was designed to determine if cytisine was at least as effective as NRT for smoking cessation.

1. Is Cytisine at least as effective as NRT for smoking
cessation?

2. ● BACKGROUND
● Cytisine is a plant-based Alkaloid found in members of the Leguminosae
family,a partial agonist that binds the nicotinic acetylcholine receptors
(nAChRs)
● Cytisine is used for smoking cessation,it has been available both with and
without prescription for smoking cessation since 1960s largely in Eastern
Europe
● Cytisine is a generic agent currently manufactured by Sopharma as Tabex
and Aflofarm Pharma as Desmoxan

3. ● 4 Systematic reviews report Cytisine to be superior to
placebo for short-term and long-term abstinence and
almost doubles the chances of quiting at 6 months
● Given that no trials have compared Cytisine with
Nicotine Replacement Therapy(NRT),we designed a
non-inferiority trial to investigate wether Cytisine was at
least as effective as NRT

4. ● METHODS
● 1310 -(655 per group) adult smokers were randomly assigned in a1:1
ratio to receive Cytisine for 25 days or NRT for 8 weeks
● Participants-Inclusion criteria
● Smokers motivated to qiut(were recruited through the New Zealand Quitline
● To be at lesast 18 of age
● Dayli smokers
● Able to provide verbal consent
● Have access to telephone
● Participants-Exclusion criteria
● Pregnant/Breastfeeding
● Non-dayli smokers
● Current users of NRT products
● Currently enrolled in another smoking cessation study
● Heart attack,uncontrolled high blood pressure, schizophrenia

5. ● TREATMENT ALLOCATION
● INTERVENTION GROUP
25 days course of Cytisine(1.5
mg per tablet)
● Days 1-3 : 1 tablet/2 hrs
through the day
● Days 4-12 : 1 tablet/2.5 hrs;
DESIGNED QD is day5
● Days 13-16 : 1 tablet/3 hrs
● Days 17-20 : 1 tablet/4-5 hrs
● Days 21-25 : 1 tablet/6 hrs
● USUAL CARE GROUP
8 weeks NRT :
● Nicotine Patches :7,14 or 21 mg
and/or gum: 2 mg or 4 mg
or lozenge: 1 mg or 2 mg
● Type and strenght of NRT were
determinated by Quitline
advisors

6. ● TREATMENT REGIME
● CYTISINE/TABEX
Days 1-3 : 1.5 mg/2 hours
Days 4-12 :1.5 mg /2.5 hours
DESIGNED QIUT DAY- DAY 5
Days 13-16 : 1.5 mg/3 hours
Days 17-20 : 1.5 mg/4-5 hours
Days 21 -25 : 1.5 mg/6 hours
● VARENICLINE/CHAMPIX
Days 1-3 : 0.5 mg once daily
Days 4-7 : 0.5 mg twice daily
DESIGNED QUIT DAY- DAY 7-14
Day 8 to week 12 :n1n mg twice daily

7. ● BASELINE CHARACTERISTIC OF THE PARTICIPANTS
CHARACTERISTICS CYTISINE
N=655
NRT
N=655
FEMALE SEX-no(%) 372(57%) 372(57%)
AGE(yrs) 37.8 38.4
CIGARETTES SMOKED PER DAY 19.3 19.0
CIGARETTE DEPENDENCE 5.4 5.3
AGE STARTED SMOKING(yrs) 15.2 15.5

8. ● OUTCOMES
● Primary outcomes
● continuous abstinence since quit day
● Secondary outcomes - assessed at 1 week and 1,2, and 6 months(after
quit day)
● total number of Cytisine tablets taken or the type,strenght and amount of
NRT
● 7-Day piont preavalance for abstinence(no cigarettes,not a single puff in the
previous 7 days)