Dataset Information

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial.

ABSTRACT:

Background

The standard way to stop smoking is to stop abruptly on a quit day with no prior reduction in consumption of cigarettes. Many smokers feel that reduction is natural and if reduction programmes were offered, many more might take up treatment. Few trials of reduction versus abrupt cessation have been completed. Most are small, do not use pharmacotherapy, and do not meet the standards necessary to obtain a marketing authorization for a pharmacotherapy.

Design/methods

We will conduct a non-inferiority randomised trial of rapid reduction versus standard abrupt cessation among smokers who want to stop smoking. In the reduction arm, participants will be advised to reduce smoking consumption by half in the first week and to 25% of baseline in the second, leading up to a quit day at which participants will stop smoking completely. This will be assisted by nicotine patches and an acute form of nicotine replacement therapy. In the abrupt arm participants will use nicotine patches only, whilst smoking as normal, for two weeks prior to a quit day, at which they will also stop smoking completely. Smokers in either arm will have standard withdrawal orientated behavioural support programme with a combination of nicotine patches and acute nicotine replacement therapy post-cessation. OUTCOMES/FOLLOW-UP: The primary outcome of interest will be prolonged abstinence from smoking, with secondary trial outcomes of point prevalence, urges to smoke and withdrawal symptoms. Follow up will take place at 4 weeks, 8 weeks and 6 months post-quit day.

Trial registration

Current Controlled Trials ISRCTN22526020.

SUBMITTER: Lindson N

PROVIDER: S-EPMC2739194 | biostudies-literature | 2009 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial.

Lindson Nicola N Aveyard Paul P Ingram Jackie T JT Inglis Jennie J Beach Jane J West Robert R Michie Susan S

Trials 20090814

<h4>Background</h4>The standard way to stop smoking is to stop abruptly on a quit day with no prior reduction in consumption of cigarettes. Many smokers feel that reduction is natural and if reduction programmes were offered, many more might take up treatment. Few trials of reduction versus abrupt cessation have been completed. Most are small, do not use pharmacotherapy, and do not meet the standards necessary to obtain a marketing authorization for a pharmacotherapy.<h4>Design/methods</h4>We wi ...[more]

PMID: 19682359

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Project description:BackgroundPublic policy and clinical treatment in tobacco addiction in the UK has focused on cessation: an abrupt attempt to stop all cigarettes. However, recent evidence suggests that allowing more gradual withdrawal from tobacco or even permanent partial substitution by nicotine replacement therapy (NRT) could lead to net benefits to public health. No jurisdiction has introduced smoking reduction programmes in normal clinical care and the best methods for their implementation is uncertain. Community pharmacists offering smoking cessation services in the UK are ideally placed to implement reduction programmes.This pilot study aims therefore to examine the feasibility of implementing smoking reduction programme in pharmacies, and also to see if behavioural support and a longer treatment affect the success rate for cessation.Design and methodsThis is a 2 × 2 randomised factorial trial of behavioural support versus no support and short versus standard length reduction programme. The pharmacists will recruit 16 patients per pharmacy, 160 smokers altogether. Pharmacists will randomise each participant by sealed envelopes. In a standard supported programme, the pharmacist will give support for 34 weeks, inviting participants to set a treatment goal and providing advice on how to reduce cigarette use. Participants in the short programme will be given the same advice on how to reduce but will reduce smoking over four weeks. Participants in the no support arms will be given a leaflet that describes the reduction programmes in 4-week and 34-week format. All participants are encouraged to use of NRT to support the reduction. These processes will be measured by recording the number of recruited smokers; percentage of those who reduce and sustain their consumption to at least 50% of baseline value, and the proportion of people who attain 4 weeks abstinence and 6 months abstinence. Interviews will assess smokers' and pharmacists' views on the way the programme ran.DiscussionThis is a pilot study to assess the feasibility of offering smoking reduction programme within pharmacies that offer naturalistic setting to show population benefit from these programmes. Findings from this trial will inform the development of evidence-based treatment for smokers who want to reduce and best approaches to engage reluctant quitters onto the programme.Trial registrationCurrent Controlled Trials ISRCTN 2010-019259-24.

Project description:BackgroundFueled by rapid technological advances over the past decade, there is growing interest in the use of smartphones to aid in smoking cessation. Hundreds of applications have been developed for this purpose, but little is known about how these applications are accessed and used by smokers or what features smokers believe would be most useful.PurposeThe present study sought to understand the prevalence of smartphone ownership and patterns of use among smokers as well as the perceived utility of various smartphone application features for smoking cessation that are currently in development or already available.MethodsDaily cigarette smokers (n = 224) reported on smartphone ownership, their patterns of smartphone usage, and perceived utility of features. Features were ranked according to perceived utility and differences in both perceived utility and general smartphone use patterns were examined as a function of demographic and smoking-related variables.ResultsMost smokers (80.4%) own a smartphone, but experience with smoking cessation applications is extremely rare (6.1%). Ownership and patterns of usage differed as a function of demographic and smoking-related variables. Overall, gain-framed features were rated as most useful, while loss-framed and interpersonal features were rated as least useful.ConclusionsMobile health interventions have the potential to reach a large number of smokers but are currently underutilized. Additional effort is needed to ensure parity in treatment access. Gain-framed messages may be especially useful for engaging smokers, even if other features ultimately drive treatment effects.ImplicationsThis study describes patterns of smartphone usage among smokers and identifies the smartphone application features smokers believe would be most useful during a quit attempt. Findings indicate which subgroups of smokers are most likely to be reached with mobile health interventions and suggests that inclusion of specific features may be helpful for engaging smokers in the smoking cessation process.

Project description:BACKGROUND:Brief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown. METHODS:Primary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires. FINDINGS:58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19·9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ?8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary. INTERPRETATION:Prespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures. TRIAL REGISTRATION NUMBER:NCT01638338; Results.

Project description:IntroductionNon-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit.MethodsITS (smoking 4-27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects.ResultsNicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58-3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time.ConclusionsNicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence.ImplicationsNicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS' smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence.

Project description:INTRODUCTION The number of cessation clinics in China have been increasing ever since the Chinese government supported the establishment of smoking cessation clinics (SCCs) in each province in 2014. Many studies have examined smoking cessation behaviors among male smokers, but few of female smokers. This study aimed to understand female smokers’ quitting behaviors in SCCs and identify predictors of successful cessation. METHODS This study used data of the SCCs Platform in China from 2018 to 2020. The self-reported 7-day point prevalence of abstinence rate (PPAR) at 1 month and at 3 months follow-up and the continuous abstinence rate (CAR) at 3 months follow-up are reported based on smokers’ characteristics and intention to treat analysis. A multiple logistic regression model was used to identify predictors of continuous abstinence at 3 months follow-up. RESULTS The 7-day PPAR of female outpatients in SCCs was 29.20% at 1 month follow-up and 28.36% at 3 months follow-up. The CAR at 3 months follow-up was 19.88%. Female smokers who were prepared to quit within 7 days (AOR=2.86; 95% CI: 1.53–5.32), today (AOR=4.01; 95% CI: 2.35–6.85), had started to quit (AOR=7.11; 95% CI: 4.12–12.27), and used a combination of counseling and drugs (AOR=2.41; 95% CI: 1.73–3.35) were more likely to quit smoking. Associated with lower quitting rates were: living in the central region of China (AOR=0.47; 95% CI: 0.31–0.73) and the west region (AOR=0.48; 95% CI: 0.31–0.73); being aged 30–39 years (AOR=0.39; 95% CI: 0.23–0.64), and 40–49 years (AOR=0.41; 95% CI:0.24–0.69); being unemployed (AOR=0.64; 95% CI: 0.45–0.91); having a fair perceived health status at the first visit (AOR=0.65; 95% CI: 0.47–0.91) and a poor one (AOR=0.37; 95% CI: 0.21–0.64); having a moderate nicotine dependence (AOR=0.64; 95% CI: 0.44–0.92) and a severe one (AOR=0.50; 95% CI: 0.34–0.72). CONCLUSIONS In our study, the region of residence, age, employment, perceived health status, Fagerström test for nicotine dependence (FTND), readiness to quit, and intervention model were independent predictors of quitting for female smokers. Improving the motivation to quit, providing intensive psychological interventions and equipping SCCs with cessation medication would assist female smokers to quit.

Dataset Information

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial.

Background

Design/methods

Trial registration

Publications

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial.

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