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Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

ABSTRACT: The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: I Adherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype). II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype.An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:i. NRT oral dose tailored by DNA analysis (OPRM1 gene) (genotype), orii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II).This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. TRIAL DETAILS: Funder: Medical Research Council (MRC)Grant number: G0500274. ISRCTN: 14352545. Date trial stated: June 2007. Expected end date: December 2009. Expected reporting date: December 2010.

SUBMITTER: Marteau TM

PROVIDER: S-EPMC2996370 | biostudies-literature | 2010 Nov

REPOSITORIES: biostudies-literature

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Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

Marteau Theresa M TM Munafò Marcus R MR Aveyard Paul P Hill Chloe C Whitwell Sophia S Willis Thomas A TA Crockett Rachel A RA Hollands Gareth J GJ Johnstone Elaine C EC Wright Alison J AJ Prevost A Toby AT Armstrong David D Sutton Stephen S Kinmonth Ann Louise AL

BMC public health 20101109

<h4>Background</h4>The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: I Adherence to NRT is greater among smokers informed tha ...[more]

PMID: 21062464

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Project description:IntroductionSmoking during pregnancy remains common, and the English National Health Service (NHS) has recently been directed to prioritize providing cessation support for pregnant women. We investigated the impact on prescribing of stop smoking treatments to pregnant women of the 2013 transfer of public health budgets from the NHS to administrative authorities responsible for local social care and other nonhealth services (local authorities).MethodsWe used data from the Clinical Practice Research Datalink and Hospital Episode Statistics to determine annual proportions (2005-2017) of women who smoked during pregnancy and who were prescribed, at least once before childbirth, (1) any NRT and (2) long- and short-acting NRT together (dual NRT). Segmented regression was used to quantify the impact of the 2013 transfer of smoking cessation budgets to local authorities, assessing changes in the level and the trend of the proportions post-2013 compared with pre-2013.ResultsWe identified 84 539 pregnancies in which women were recorded as smoking; any NRT was prescribed in 7.9% (n = 6704) and dual NRT in 1.7% (n = 1466). Prescribing of any NRT was declining prior to 2013 at an absolute decrease of -0.25% per year, but the rate of decline significantly increased from 2013 onwards to -1.37% per year. Prescribing of dual NRT was increasing prior to 2013 but also decreased post-2013.ConclusionsThese findings suggest that transferring responsibility for English Smoking Cessation Services from the NHS to local authorities adversely affected provision of cessation support in pregnancy. Consequently, some women may have been denied access to effective cessation treatments.ImplicationsWomen who smoke during pregnancy may be being denied potentially effective means to help them quit, contrary to NICE guidance, at what can be a teachable moment with substantial immediate and longer-term health benefits for woman and their unborn child, and economic benefits for the NHS. When the organizations responsible for offering smoking cessation support are changed, health systems should consider potential adverse effects on the delivery of support and deploy strategies for mitigating these.

Project description:The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard 8 weeks. This decision was based in part on data showing increased efficacy for 24 weeks of treatment. Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit.To compare 8 (standard), 24 (extended), and 52 (maintenance) weeks of nicotine patch treatment for promoting tobacco abstinence.We recruited 525 treatment-seeking smokers for a randomized clinical trial conducted from June 22, 2009, through April 15, 2014, through 2 universities.Smokers received 12 smoking cessation behavioral counseling sessions and were randomized to 8, 24, or 52 weeks of nicotine patch treatment.The primary outcome was 7-day point prevalence abstinence, confirmed with breath levels of carbon monoxide at 6 and 12 months (intention to treat).At 24 weeks, 21.7% of participants in the standard treatment arm were abstinent, compared with 27.2% of participants in the extended and maintenance treatment arms (?(2)(1)?= 1.98; P =?.17). In a multivariate model controlled for covariates, participants in the extended and maintenance treatment arms reported significantly greater abstinence rates at 24 weeks compared with participants in the standard treatment arm (odds ratio [OR], 1.70 [95% CI, 1.03-2.81]; P =?.04), had a longer duration of abstinence until relapse (? = 21.30 [95% CI, 10.30-32.25]; P <?.001), reported smoking fewer cigarettes per day if not abstinent (mean [SD], 5.8 [5.3] vs 6.4 [5.1] cigarettes per day; ? = 0.43 [95% CI, 0.06-0.82]; P =?.02), and reported more abstinent days (mean [SD], 80.5 [38.1] vs 68.2 [43.7] days; OR, 1.55 [95% CI, 1.06-2.26]; P =?.02). At 52 weeks, participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms (20.3% vs 23.8%; OR, 1.17 [95% CI, 0.69-1.98]; P =?.57). Similarly, we found no difference in week 52 abstinence rates between participants in the extended and standard treatment arms (26.0% vs 21.7%; OR, 1.33 [95% CI, 0.72-2.45]; P =?.36). Treatment duration was not associated with any adverse effects or adherence to the counseling regimen, but participants in the maintenance treatment arm reported lower adherence to the nicotine patch regimen compared with those in the standard and extended treatment arms (mean [SD], 3.94 [2.5], 4.61 [2.0], and 4.7 [2.4] patches/wk, respectively; F2,522 = 6.03; P =?.003).The findings support the safety of long-term use of nicotine patch treatment, although they do not support efficacy beyond 24 weeks of treatment in a broad group of smokers.clinicaltrials.gov Identifier: NCT01047527.

Project description:BackgroundPregnant smokers may be offered nicotine replacement therapy (NRT) alongside behavioral support to assist with a quit attempt. Yet trials of NRT have found adherence to be low among pregnant women, and this has made it difficult to determine the efficacy of NRT. The aim of this study is to understand the experience of pregnant women who use NRT but discontinue this early or do not use the medication as recommended.MethodsSemi-structured telephone interviews were conducted with 14 pregnant smokers who had recently been prescribed NRT, but self-reported poor NRT adherence or discontinuing treatment prematurely. Data were transcribed and analyzed using inductive thematic analysisResultsThere were four main themes identified; expectations of NRT, experience of using NRT, safety concerns and experience of using e-cigarettes. Some women intentionally used NRT to substitute a proportion of their cigarette intake and smoked alongside. Most women smoked while using NRT. Women who underutilized NRT did so as they experienced side effects, or were concerned that using NRT instead of smoking could actually increase their nicotine exposure and potential for increased nicotine dependence or fetal harm. Most women spoke about the use of e-cigarettes as a smoking cessation method but only a few had actually experienced using them during pregnancy.ConclusionMany women underused NRT but simultaneously smoked. Challenging negative perceptions about NRT and educating women further about the risks of smoking may encourage them to use NRT products as recommended.ImplicationsThese findings add to the research surrounding the efficacy of NRT during pregnancy by providing insight into how pregnant women use NRT during a quit attempt and how this may influence adherence. It may assist health professionals to support pregnant smokers by increasing their understanding about the differing ways in which women use NRT and help them address concerns women may have about the safety of NRT.

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Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

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Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

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