Cost-free pharmacotherapy in smokers with TIA or stroke: QUIT-MED randomised controlled trial

Abstract

Objective To examine whether cost-free (CF) smoking cessation medication was more effective than a prescription for cessation medication in patients after transient ischaemic attack (TIA) or stroke.Design Two-site randomised trial.Setting Stroke prevention clinics (SPCs) in Ontario, Canada.Participants Smokers with TIA or stroke, willing to quit smoking.Intervention Smoking status was assessed in SPC attendees. Smokers were advised to quit smoking and received recommendations for cessation medication and counselling. Consenting participants were randomly assigned (1:1) to either a CF medication group or a prescription-only (Rx) group. CF participants immediately received a 12-week supply of cessation medication. Rx participants were given a prescription for 12 weeks of cessation medication. Follow-up counselling was provided for 26 weeks.Main outcome The primary outcome was 40-week continuous abstinence verified using a carbon monoxide breath test at 52-week follow-up. Secondary outcomes included abstinence at intermediate timepoints, medication adherence and serious adverse events.Results Hundred and ninety-four participants were randomised and 131 (67.5%) completed the trial. The 40-week continuous abstinence rate at 52-week follow-up was 15.5% in the CF group versus 14.0% in the Rx group (OR=1.13; 95% CI 0.51 to 2.53). The 14-week continuous abstinence rate at 26-week follow-up was 18.6% in the CF group versus 16.8% in the Rx group (OR=1.20; 95% CI 0.56 to 2.55). Seven-day point-prevalence abstinence at 12 weeks was 38.1% in the CF group versus 26.9% in the Rx group (OR=1.76; 95% CI 0.94 to 3.28). Medication adherence was higher in the CF group versus the Rx group (47.4%±41.2% vs 25.5±36.8%, p<0.001). Serious adverse events occurred in 11.1% of participants and were unrelated to treatment.Conclusions Our findings were inconclusive; we failed to meet our recruitment target and the effect size was smaller than anticipated. CF medication improved medication adherence.Trial registration number NCT00962988; ClinicalTrials.gov Identifier.