Smoking Cessation Resource Center: Clinical Studies

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy

Saul Shiffman, Clyde N. Rolf, Stephen J. Hellebusch, Jane Gorsline, Charles W. Gorodetzky, Yu-Kun Chiang, Debra S. Schleusener & Michael E. Di Marino
November 27, 2001

Aims
To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings.

Design
Separate open-label studies with gum and patch in OTC and Rx settings.

Participants
There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.

Interventions
All smokers received active nicotine replacement. In the OTC setting, smokers self-selected doses of nicotine gum (2 or 4mg Nicorette^®) or patch (21, 14 or 7mg NicoDerm^® CQ). No intervention was provided. In the Rx setting, smokers were prescribed gum or patch by their physician.

Measurements
Biochemically verified continuous smoking abstinence was assessed at 6 weeks (28-day abstinence) and 6 months.

Findings
OTC success rates were consistently higher than Rx rates: differences were significant at 6 weeks for both patch [OR = 1.45 (1.05-1.98)] and gum [OR = 2.92 (1.58-5.40)], and remained significant at 6 months for patch [OR = 3.63; (1.74-7.61)] but not gum [OR = 1.37; (0.73-2.58)]. Among OTC gum users, 16.1% were abstinent at 6 weeks and 8.4% at 6 months. For Rx gum users, abstinence rates were 7.7% at 6 weeks and 7.7% at 6 months. With OTC patch, 19.0% were abstinent at 6 weeks and 9.2% at 6 months. With Rx patch, abstinence rates were 16.0% at 6 weeks and 3.0% at 6 months.

Conclusions
Smoking cessation rates achieved with nicotine gum and patch under OTC conditions were as good as those under real-world prescribing conditions.

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