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J
Jelko Daskalov

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.

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Is Cytisine at least as effective as NRT for smoking cessation?
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
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
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
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
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
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
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)
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  • 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)