Abstract
BackgroundNicotine 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.MethodsThis study was a pragmatic double-blind randomised controlled trial with remote recruitment through leaflets distributed to over 300 UK-based community pharmacies. The study recruited adult daily smokers (≥10 cigarettes per day) who bought NRT, wanted to quit smoking, downloaded NTR2Quit and completed the registration process within the app. Participants were automatically randomly assigned 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.ResultsThe study under-recruited. Only 41 participants (3.5% of the target sample) were randomly assigned to NRT2Quit (n = 16) or the control (n = 25) app versions between March 2015 and September 2016. The follow-up rate was 51.2%. The intervention participants had numerically higher biochemically verified quit rates (25.0% versus 8.0%, P = 0.19, odds ratio = 3.83, 0.61–24.02). The calculated Bayes factor, 1.92, showed that 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 versus 0, P = 0.01) and were more likely to use NRT at follow-up (100.0% versus 28.6%, P = 0.03) and recommend NRT2Quit to others (100.0% versus 28.6%, P = 0.01).ConclusionsDespite very low recruitment, there was preliminary but inconclusive evidence that NRT2Quit may improve short-term abstinence and adherence among smokers using NRT. Well-powered studies on NRT2Quit are needed, but different recruitment methods will be required to engage smokers through community pharmacies or other channels.Trial registrationISRCTN ISRCTN33423896, prospectively registered on 22 March 2015.
Highlights
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
High-quality evidence from randomised trials shows that nicotine replacement therapy (NRT) is effective when provided with at least some professional support [56]
Large-scale surveys and prospective studies have found that smokers who buy NRT over the counter (OTC NRT) and do not receive any processional support have quit rates that are similar to, or lower than, those of smokers who quit unaided, even when a range of potential confounding variables are adjusted for [33,34,35]
Summary
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. One explanation for the discrepancy in effectiveness between NRT in trials and NRT bought OTC is low adherence [3, 5, 15, 19, 31, 48, 55]. Smartphone applications (apps) could improve NRT adherence and success rates in smokers, especially among those using OTC NRT [36, 47, 49]. Apps have been developed to promote smoking cessation, but many of these have been shown to offer only limited support with quitting, and as yet none has been developed to promote NRT adherence [1, 2, 29, 59]
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