The blind spot in the nicotine replacement therapy literature: Assessment of the double-blind in clinical trials

2004 ◽  
Vol 29 (4) ◽  
pp. 673-684 ◽  
Author(s):  
Marc Mooney ◽  
Thom White ◽  
Dorothy Hatsukami
Keyword(s):  
Clinical Trials ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Blind Spot ◽  
Double Blind ◽  
Nicotine Replacement

scholarly journals Evaluating level of adherence to nicotine replacement therapy and its impact on smoking cessation: a protocol for systematic review and meta-analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e039775 ◽  
Author(s):  
Amanual Getnet Mersha ◽  
Parivash Eftekhari ◽  
Michelle Bovill ◽  
Daniel Nigusse Tollosa ◽  
Gillian Sandra Gould
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Smoking Cessation ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Assessment Tool ◽  
Meta Analysis ◽  
Population Based ◽  
Reverse Causality ◽  
Nicotine Replacement

IntroductionNicotine replacement therapy (NRT) has proven effective for smoking cessation in clinical trials, however it was found less effective in population-based studies, potentially due to inconsistent or incorrect use of NRT. The aim of this paper is to describe a systematic review protocol to evaluate level of adherence to NRT; the discrepancy of adherence to NRT in clinical and population-based studies and degree of association between level of adherence and success of smoking cessation.Methods and analysisLiterature search will use five databases (Medline, Scopus, Embase, CINAHL and PsycINFO). Studies will be appraised for methodological quality using National Institutes of Health Quality Assessment Tool. To reduce heterogeneity, we will analyse clinical trials and population-based studies separately; pooled analyses will be done among studies that used similar measurements. Heterogeneity of studies will be assessed by Higgins’ I2 statistical test. When studies are adequately homogeneous, results will be pooled using random-effects model with proportion and ORs with 95% CIs and p values for each outcome. We will explain sources of heterogeneity by subgroup analysis or sensitivity analysis. Funnel plots and Egger’s regression asymmetry test with p<0.05 will be used as a cut-off point to affirm presence of statistically significant publication bias. Statistical analyses will be carried out using Stata V.16 software. Only studies reporting a valid strategy to control for reverse causality will be included.DiscussionThis review will provide evidence to support the importance of adherence on rate of smoking cessation and level of adherence to NRT. The findings will be used to inform smoking cessation interventions, researchers and policymakers.Ethics and disseminationAs a systematic literature review, this protocol does not require ethics approval. Research outcomes will be presented at relevant conferences and findings will be published in a relevant peer-reviewed journal.PROSPERO registration numberCRD42020176749.

Randomized, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy

2001 ◽  
Vol 62 (4) ◽  
pp. 274-278 ◽  
Author(s):  
Bhushan Kapur ◽  
Richard Hackman ◽  
Peter Selby ◽  
Julia Klein ◽  
Gideon Koren
Keyword(s):  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Controlled Trial ◽  
Double Blind ◽  
Nicotine Replacement ◽  
Double Blind Placebo ◽  
In Pregnancy

scholarly journals Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence - results of a prematurely terminated study

2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Jamie Brown ◽  
Lion Shahab ◽  
Robert West ◽  
Tobias Raupach
Keyword(s):  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Bayes Factor ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Smartphone App ◽  
Community Pharmacies ◽  
Double Blind ◽  
Nicotine Replacement

Abstract Background: Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2Quit smartphone app (for iOS) designed to improve quit attempts with OTC NRT by improving adherence to the medications. Methods: A pragmatic double-blind randomized controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cig/day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomized within the app to the intervention (full) version of NRT2Quit or to its control (minimal) versions. The primary outcome was biochemically-verified 4-week abstinence assessed at 8-week follow-up using Russell Standard criteria and intention-to-treat. Bayes factors were calculated for the cessation outcome. Secondary outcomes were self-reported abstinence, NRT use, app use and satisfaction with the app. Results: The study under-recruited with only 41 participants (3.5% of the target sample) randomly assigned to NRT2Quit (n=16) or the control (n=25) app versions between March 2015-September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically-verified quit rates (25.0% vs 8.0%, p=0.19, OR=3.83,0.61-24.02). The Bayes factor calculated was 1.92 showed the data were insensitive to test for the hypothesis that the intervention app version aided cessation. The intervention participants had higher median logins (2.5 vs. 0, p=0.01), were more likely to use NRT at follow-up (100.0% vs. 28.6%, p=0.03) and recommend NRT2Quit to others (100.0% vs. 28.6%, p=0.01). Conclusions: Despite very low recruitment there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using nicotine replacement therapy. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.

Effect of Nicotine Replacement Therapy on Agitation in Smokers With Schizophrenia: A Double-Blind, Randomized, Placebo-Controlled Study

2011 ◽  
Vol 168 (4) ◽  
pp. 395-399 ◽  
Author(s):  
Michael H. Allen ◽  
Martin Debanné ◽  
Coralie Lazignac ◽  
Eric Adam ◽  
L. Miriam Dickinson ◽  
...  
Keyword(s):  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Controlled Study ◽  
Double Blind ◽  
Nicotine Replacement
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