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A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients.

ABSTRACT: Background Tobacco use is a major risk factor for recurrent stroke. The provision of cost-free quit smoking medications has been shown to be efficacious in increasing smoking abstinence in the general population. Objective The objective of this pilot study was to assess the feasibility and obtain preliminary data on the effectiveness of providing cost-free quit smoking pharmacotherapy and counselling to smokers identified in a stroke prevention clinic. Trial design Cluster randomised controlled trial. Methods All patients seen at the Ottawa Hospital Stroke Prevention Clinic who smoked more five or more cigarettes per day, were ready to quit smoking in the next 30 days, and were willing to use pharmacotherapy were invited to participate in the study. All participants were advised to quit smoking and treated using a standardised protocol including counselling and pharmacotherapy. Participants were randomly assigned to either a prescription only usual care group or an experimental group who received a 4-week supply of cost-free quit smoking medications and a prescription for medication renewal. All patients received follow-up counselling. The primary outcome was biochemically validated quit rates at 26 weeks. The research coordinator conducting outcome assessment was blind to group allocation. Results Of 219 smokers screened, 73 were eligible, 28 consented and were randomised, and 25 completed the 26-week follow-up assessment. All 28 patients randomised were included in the analysis. The biochemically validated 7-day point prevalence abstinence rate in the experimental group compared to the usual care group was 26.6% vs 15.4% (adjusted OR 2.00, 95% CI 0.33 to 13.26; p=0.20). Conclusions It would be feasible to definitively evaluate this intervention in a large multi-site trial. Trial registration number http://ClinicalTrials.gov # UOHI2010-1.

SUBMITTER: Papadakis S

PROVIDER: S-EPMC3225588 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients.

Papadakis Sophia S Aitken Debbie D Gocan Sophia S Riley Dana D Laplante Mary Ann MA Bhatnagar-Bost Abha A Cousineau Donna D Simpson Danielle D Edjoc Rojiemiahd R Pipe Andrew L AL Sharma Mukul M Reid Robert D RD

BMJ open 20111128 2

Background Tobacco use is a major risk factor for recurrent stroke. The provision of cost-free quit smoking medications has been shown to be efficacious in increasing smoking abstinence in the general population. Objective The objective of this pilot study was to assess the feasibility and obtain preliminary data on the effectiveness of providing cost-free quit smoking pharmacotherapy and counselling to smokers identified in a stroke prevention clinic. Trial design Cluster randomised controlle ...[more]

PMID: 22123923

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Project description: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.

Project description:INTRODUCTION:Pharmacogenomic studies have used genetic variants to identify smokers likely to respond to pharmacological treatments for smoking cessation. METHODS:We performed a systematic review and meta-analysis of primary and secondary analyses of trials of smoking cessation pharmacotherapies. Eligible were trials with data on a priori selected single nucleotide polymorphisms, replicated non-single nucleotide polymorphisms, and/or the nicotine metabolite ratio. We estimated the genotype × treatment interaction as the ratio of risk ratios (RRR) for treatment effects across genotype groups. RESULTS:We identified 18 trials (N = 9017 participants), including 40 active (bupropion, nicotine replacement therapy [NRT], varenicline, or combination therapies) versus placebo comparisons and 16 active versus active comparisons. There was statistical evidence of heterogeneity across rs16969968 genotypes in CHRNA5 with regard to both 6-month abstinence and end-of-treatment abstinence in non-Hispanic black smokers and end-of-treatment abstinence in non-Hispanic white smokers. There was also heterogeneity across rs1051730 genotypes in CHRNA3 with regard to end-of-treatment abstinence in non-Hispanic white smokers. There was no clear statistical evidence for other genotype-by-treatment combinations. Compared with placebo, NRT was more effective among non-Hispanic black smokers with rs16969968-GG with regard to both 6-month abstinence (RRR for GG vs. GA or AA, 3.51; 95% confidence interval [CI] = 1.19 to 10.30) and end-of-treatment abstinence (RRR for GG vs. GA or AA, 5.84; 95% CI = 1.89 to 18.10). Among non-Hispanic white smokers, NRT effectiveness relative to placebo was comparable across rs1051730 and rs169969960 genotypes. CONCLUSIONS:We did not identify widespread differential effects of smoking cessation pharmacotherapies based on genotype. The quality of the evidence is generally moderate. IMPLICATIONS:Although we identified some evidence of genotype × treatment interactions, the vast majority of analyses did not provide evidence of differential treatment response by genotype. Where we find some evidence, these results should be considered preliminary and interpreted with caution because of the small number of contributing trials per genotype comparison, the wide confidence intervals, and the moderate quality of evidence. Prospective trials and individual-patient data meta-analyses accounting for heterogeneity of treatment effects through modeling are needed to assess the clinical utility of genetically informed biomarkers to guide pharmacotherapy choice for smoking cessation.

Project description:IntroductionConverging clinical and biological evidence suggest sex is an important factor when selecting a pharmacological intervention for smoking cessation. The current investigation used network meta-analyses to estimate sex differences in the comparative efficacy of transdermal nicotine (TN), varenicline, and sustained release (SR) bupropion for smoking cessation.MethodsSystematically searched previously published reviews and databases (Medline, PsycINFO, Embase) of randomized, double-blind, placebo-controlled trials of bupropion-SR, TN, and varenicline for cigarette smoking cessation in primary care/general community samples were included.ResultsThirty-two studies met all criteria and 28 (88%) were included in the final analyses, representing 14 389 smokers (51% female). Results of the full sample (women and men combined) mirrored those from a Cochrane Tobacco Addiction Group network meta-analysis of smoking cessation pharmacotherapy, showing VAR>TN=BUP. All medications improved quit rates over placebo for both women and men. Relative to placebo, varenicline efficacy was similar for women and men. Significant sex differences were evident when comparing varenicline versus TN and varenicline versus bupropion. For women, varenicline was more efficacious than TN (RR = 1.41; 95% CI = 1.12,1.76) and bupropion (RR = 1.38; 95% CI = 1.08,1.77). For men, outcomes for those treated with TN and bupropion were similar to those treated with varenicline. There were no differences in efficacy when comparing bupropion versus TN.ConclusionsThe advantage of varenicline over bupropion SR and TN is greater for women than men. Clinicians should strongly consider varenicline as the first option treatment for women. Among men, the advantage of varenicline over TN or bupropion is less clear.ImplicationsThis study provides information for the sex-informed treatment of nicotine addiction among cigarette smokers. Relative to placebo, women and men achieved similar outcomes when treated with varenicline; however the advantages of varenicline over transdermal patch and bupropion were greater for women compared to men.

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A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients.

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A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients.

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