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

Hurt, R. Douglas; Lauger, Gary G.; Offord, Kenneth P.; Kottke, Thomas E.; Dale, Lowell C.

doi:10.1016/s0025-6196(12)62186-7

Cited by 105 publications

(21 citation statements)

References 14 publications

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“…When results from the three active treatment groups were pooled, the overall success rate was 17%, which is similar to other studies using patches [4][5][6][7][9][10][11]. This observation suggests that the relatively low success rate observed in previous trials may be ascribed to the presence of smokers with different baseline characteristics (e.g.…”

Section: Discussionsupporting

confidence: 84%

“…11% for HC-15 and 9% for HC-25), and this was not affected by a dose increase from 15 to 25 mg nicotine. The design of the study deliberately did not include a placebo treatment in the high cotinine plasma values group, since many reports have already demonstrated the efficacy of nicotine replacement therapy when compared to placebo [4,[6][7][8][9][10]. Hence, for ethical reasons we decided to provide these heavy smokers with some nicotine and to compare 15 mg nicotine versus 25 mg nicotine replacement.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, nicotine replacement has become important in smoking cessation programmes, and most clinical trials have demonstrated its efficacy [4][5][6][7][8][9][10][11][12]. The use of nicotine chewing gum [5] and, more recently, that of skin patches [4,[6][7][8][9][10][11][12], as well as nicotine nasal spray [13] and nicotine inhaler [14], have shown higher rates of success when compared with placebo.…”

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confidence: 99%

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Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch

Paoletti¹,

Fornai²,

Maggiorelli³

et al. 1996

Eur Respir J

109

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Nicotine replacement by transdermal patches is more effective than placebo in smoking cessation, but has a low success rate after one year (9-18%). We tested whether this was attributed to insufficient nicotine replacement.We conducted a randomized trial to investigate the effect on outcome of different doses of transdermal nicotine replacement after stratification according to baseline plasma cotinine values. Two hundred and ninety seven adult smokers were enrolled. Those with baseline cotinine ≤250 ng·ml -1 (low cotinine) were randomly assigned to placebo (LC-P) or to 15 mg 16 h nicotine patches (LC-15), and those with baseline cotinine >250 ng·mL -1 (high cotinine) were randomly assigned to 15 mg (HC-15) or 25 mg (HC-25) 16 h nicotine patches. Plasma nicotine and cotinine values, expired carbon monoxide and withdrawal symptoms were measured at scheduled intervals during treatment.Smokers in the LC-15 group had a significantly higher success rate than placebo (28 vs 9%). Smokers with high baseline cotinine had lower success rates, and a high dose of nicotine did not increase success rate (HC-25 9% vs HC-15 11%). Subjects in the HC-15 group had the lowest percentage of nicotine replacement and a higher prevalence of withdrawal symptoms than the HC-25 group. Replacement was similar in groups LC-15 and HC-25, but the success rate was significantly lower in HC-25 group, despite similar levels of withdrawal symptoms.We conclude that a higher success rate was obtained after one year in smokers with low baseline plasma cotinine values. Determination of plasma cotinine values may be, thus, helpful in identifying smokers who could benefit from transdermal nicotine replacement.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch

Paoletti¹,

Fornai²,

Maggiorelli³

et al. 1996

Eur Respir J

109

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“…In the present study these findings are supported by the fact that more than one third of current smokers declared that they had made substantial efforts to stop during the preceding 2 years. This may correspond with earlier findings that a smoker has an almost 40% probability of trying to stop during a given year, but is unlikely to remain abstinent after any single attempt (19). To stop smoking is probably more often a process of behaviour change and social support during abstinence than lack of knowledge about smoking as a health hazard (20).…”

Section: Discussionsupporting

confidence: 87%

“…They had obtained information in different ways including: participation of husband or wife (n= 20), from relatives or friends (n= 19), and via the media (n = 34); 19 individuals could not specify the source. A total of 220 individuals (62%) of those interviewed were participants or had otherwise become familiar with the screening project.…”

Section: Resultsmentioning

confidence: 99%

Awareness and treatment of cardiovascular disease risk factors among middle-aged Swedish men and women

Ovhed

Odeberg

Troein

et al. 1998

Scandinavian Journal of Primary Health Care

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Cigarette Smoking, Nicotine Addiction, and Its Pharmacologic Treatment

Lee¹,

D’Alonzo²

1993

Arch Intern Med

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Cigarette smoking is the most prevalent modifiable risk factor for increased morbidity and mortality in the United States and perhaps the world. Not only does the smoker incur medical risks attributable to smoking, passive smokers and society also bear ill effects and increased economic costs attributable to the smoker's habit. These risks of morbidity and mortality have been shown to be related to the addictive component of tobacco smoke, so that pharmacologic therapies have been studied in an attempt to modify the addiction, aid in smoking cessation, and prevent relapse. Presently, nicotine polacrilex and transdermal nicotine show some efficacy. Clonidine's efficacy has been equivocal. In addition, the combination of nicotine substitution and clonidine may be useful but will need formal investigation. Nicotine agonists and antagonists have not proven helpful. Antidepressants are being studied at this time. Nonpharmacologic modalities are briefly mentioned but play a major role in helping the smoker quit.

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

Cited by 105 publications

References 14 publications

Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch

Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch

Awareness and treatment of cardiovascular disease risk factors among middle-aged Swedish men and women

Cigarette Smoking, Nicotine Addiction, and Its Pharmacologic Treatment

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