Nicotine-Replacement Therapy With Use of a Transdermal Nicotine Patch—a Randomized Double-Blind Placebo-Controlled Trial

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.

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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

10.21203/rs.2.440/v1 ◽

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, suggesting anecdotal level of support for the hypothesis that the intervention app version aided cessation, but showed the data were insensitive. 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.

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