Cytisine Use Vs Nicotine Replacement Therapy in Relapsed Smokers with Heart Disease: Feasibility Results from a Pilot Randomized Trial.

BACKGROUND

Cytisine use has proven efficacy for smoking cessation. We plan to investigate whether cytisine use is effective for relapse recovery and conducted a pilot randomized trial to assess the feasibility of a definitive trial.

METHODS

A 2-group, single-site pilot randomized controlled trial was conducted. Adults with heart disease, who were actively enrolled in a smoking-cessation program and had relapsed to smoking, were randomly assigned to receive cytisine or combination nicotine replacement therapy for 25 days. Primary outcomes were rates of participant recruitment and treatment adherence, compared to targets. Secondary outcomes included end-of-treatment abstinence and treatment effects on cigarettes smoked per day and tobacco-withdrawal symptoms.

RESULTS

Over the course of 18 months, we screened 62 relapsed smokers, identifying 32 (52%) who were eligible. We recruited 13 participants (41% of eligible), of whom 9 (69%) completed the study. A total of 5 of 13 participants (38.5%) used study medication on ≥ 80% of the days during the treatment period (50.0% in the cytisine group vs 28.6% in the nicotine replacement therapy group). At 25 days, 1 quitter was present in the cytisine group, and no quitters were present in the nicotine replacement therapy group (16.7% vs 0%). Cigarettes smoked per day decreased over the course of treatment.

CONCLUSIONS

Modifications to trial design, trial processes, and intervention delivery are required to make a definitive trial useful. To increase recruitment level, we will use a pragmatic design embedded within typical cessation-program practices, conduct a multisite study, and expand eligibility to include participants with other clinical conditions. To increase treatment adherence, we will use simplified dosing for cytisine. Sample size for the definitive trial will be based on the number needed to determine a clinically meaningful change in long-term abstinence.

CLINCIAL TRIAL REGISTRATION

NCT04286295.