Cytisine Compared to Combination NRT in Relapsed Smokers
Status:
Not yet recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
Cigarette smoking causes cardiovascular disease (CVD) yet many smokers with CVD are unable to
quit despite strong desire to do so. Within 90 days of discharge, about 30% of smokers have
returned to daily smoking and almost 60% have relapsed by 1 year. Patients with CVD who
resume smoking are more likely to experience new events (e.g. heart attack or stroke) or die.
New approaches are required. A new type of cessation product is a plant-based medication
called Cytisine. Cytisine is taken orally over 25 days and reduces the pleasurable sensations
that smokers get from cigarettes and reduces withdrawal symptoms. The primary research
question is whether or not it is feasible to conduct a large-scale trial of the effectiveness
of this product compared to conventional nicotine replacement therapy in smokers who have
failed to quit using conventional methods. To determine feasibility, a pilot study will be
conducted of sixty smokers (30 men, 30 women) with CVD who have been treated for smoking
cessation but have relapsed within 90 days of discharge. Participants will complete a
baseline assessment and will be randomly assigned to either the combination nicotine
replacement therapy group (patch plus lozenge) or cytisine group. Participants will be
treated for 25 days and then will return to UOHI so adherence to treatment and smoking status
can be assessed. Feasibility of the larger trial will be based on: the recruitment rates;
adherence to assigned treatments; dropout rates; and differences in 25-day quit rates between
groups.