Efficacy of over-the-counter nicotine patch

Abstract

This study aimed to assess the efficacy of the nicotine patch for smoking cessation, under simulated conditions of over-the-counter sale, absent any direct instruction or behavioral treatment. In a randomized, double-blind, placebo-controlled, multicenter study, 567 smokers were randomized to an active nicotine patch (n = 283) or placebo (n = 284). Treatment followed a three-step program of 21 mg/day for 6 weeks, 14 mg/day for 2 weeks and 7 mg/day for 2 weeks. Participants received brief written instructions, an audiotape and a written User's Guide. There was no other intervention and no contact with participants between enrollment and the primary outcome assessment at 6 weeks. Analyses were based on intent to treat, with lost subjects counted as failures, and claimed abstinence was verified by carbon monoxide measures. Use of active patch produced significantly higher abstinence rates. Continuous abstinence rates (subject to a 2-week grace period) for nicotine and placebo were 19.4% and 7.0% at 6 weeks (OR = 3.2; 95% CI 1.8-5.4) and 15.2% and 5.3% at 10 weeks (OR = 3.2; 95% CI 1.7-5.9), respectively. Seven-day point-prevalence rates for nicotine and placebo patches were 26.1% and 7.7% at 6 weeks (OR = 4.2; 95% CI 2.5-7.0) and 23.3% and 7.7% at 10 weeks (OR = 3.6; 95% CI 2.2-6.1), respectively. Reported adverse events were mild and consistent with prior observations of nicotine patch use. The nicotine patch was safe and effective for smoking cessation at least during 10 weeks of treatment under open-sale conditions, without face-to-face instruction or counseling.

Economic rewarding of smoking cessation-facilitating drugs – a comparison of over-the-counter and prescribed nicotine replacement therapy

“…Although the absolute number of quitters varies considerably and generally does not reach efficacy seen in cessation programmes including behavioural therapy, in controlled trials, smokers using OTC NRT consistently reach approximately twice the quit rate of those administered placebo [6,[11][12][13][14]24], which is similar that in trials studying prescribed NRT [5,9,10,27]. From this aspect, the effect of NRTs is not dependent on additional behavioural therapy [14,24,28]. In one trial, NRT patches showed higher quit rates with OTC NRT than prescribed NRTs, although with the use of nicotine gum, such differences have not been found [25].…”

“…The proportion of patients successfully quitting smoking depends, besides other factors, in particular, on their own motivation [12] and level of nicotine dependence, represented by the Fagerström score [5]. Although the absolute number of quitters varies considerably and generally does not reach efficacy seen in cessation programmes including behavioural therapy, in controlled trials, smokers using OTC NRT consistently reach approximately twice the quit rate of those administered placebo [6,[11][12][13][14]24], which is similar that in trials studying prescribed NRT [5,9,10,27]. From this aspect, the effect of NRTs is not dependent on additional behavioural therapy [14,24,28].…”

Ten years after the Rx-to-OTC switch of nicotine replacement therapy: What have we learned about the benefits and risks of non-prescription availability?

“…A prospective population study confirmed OTC efficacy [25][26][27][28][29][30][31][32]37], but see Ref. [16] Concerns about the switch Consumers might use NRT unsafely OTC experience and studies have confirmed safe use [30,32,39] Unsupervised consumer use of OTC NRT might increase persistent use and addiction…”

“…A formal review [24] and a Cochrane meta-analysis [6] both contradicted this premise, concluding that NRT was equally effective under high or low-intensity behavioral treatment, and that NRT and behavioral treatment each contributed independently to success, but neither affected the other's success. Subsequent effectiveness studies [25] demonstrated the effect of NRT in an OTC setting by comparing OTC NRT to placebo under simulated OTC conditions [26][27][28][29] in which smokers self-selected and used the products without any instructions or counseling, relying only on the product labels. The effects of NRT in this setting [25] were comparable to those seen in medically supervised studies with behavioral treatment.…”

In smokers who lapse during nicotine patch treatment, continued patch use increases the likelihood of recovering abstinence

“…The main trial manuscript (a different paper2) reported high adherence with patches; however, it did not specify if patches were actually used to help recovery after lapses had occurred. This means that patches may not have been used during recovery from lapses.…”