Smoking cessation · Nicotine replacement
Transdermal nicotine for smoking cessation: six-month results from two multicenter controlled clinical trials
| Design | Two multicentre controlled clinical trials with pooled analysis |
|---|---|
| Treatment | Transdermal nicotine 21 mg or 14 mg daily |
| Control | Placebo patch |
| Population | 935 smokers |
| Follow-up | 6 months |
| Primary endpoint | Smoking cessation rates |
| Result | Cessation rates during the last 4 weeks of the two 6-week trials, pooled, were 61% with 21 mg, 48% with 14 mg and 27% with placebo (p<=0.001 for each active treatment versus placebo). |
| Secondary endpoints | Six-month abstinence, withdrawal symptoms, adverse effects |
Transdermal nicotine systems show considerable promise as an aid to smoking cessation.
The trial authors, in the published abstract
The trial that created nicotine replacement therapy as a product category. The 61% figure is end-of-treatment abstinence, not sustained abstinence — six-month rates are far lower, which is the perennial gap between cessation trials and cessation. Later work moved to comparing it against e-cigarettes and varenicline rather than placebo.
Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. JAMA 1991 Dec 11;266(22):3133-8.