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Over-the-counter nicotine patch therapy for smoking cessation: Results from randomized, double-blind, placebo-controlled, and open label trials

Author

Listed:
  • Hays, J.T.
  • Croghan, I.T.
  • Schroeder, D.R.
  • Offord, K.P.
  • Hurt, R.D.
  • Wolter, T.D.
  • Nides, M.A.
  • Davidson, M.

Abstract

Objectives. The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995. Methods. Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements. Results. Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group. Conclusions. In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.

Suggested Citation

  • Hays, J.T. & Croghan, I.T. & Schroeder, D.R. & Offord, K.P. & Hurt, R.D. & Wolter, T.D. & Nides, M.A. & Davidson, M., 1999. "Over-the-counter nicotine patch therapy for smoking cessation: Results from randomized, double-blind, placebo-controlled, and open label trials," American Journal of Public Health, American Public Health Association, vol. 89(11), pages 1701-1707.
    • Handle: RePEc:aph:ajpbhl:1999:89:11:1701-1707_3
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    Cited by:

    1. Shiffman, Saul & Sweeney, Christine T., 2008. "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?," Health Policy, Elsevier, vol. 86(1), pages 17-26, April.
    2. Theodore E. Keeler & Teh‐wei Hu & Alison Keith & Richard Manning & Martin D. Marciniak & Michael Ong & Hai‐Yen Sung, 2002. "The benefits of switching smoking cessation drugs to over‐the‐counter status," Health Economics, John Wiley & Sons, Ltd., vol. 11(5), pages 389-402, July.
    3. Rosemary Avery & Donald Kenkel & Dean Lillard & Alan Mathios, 2007. "Regulating advertisements: the case of smoking cessation products," Journal of Regulatory Economics, Springer, vol. 31(2), pages 185-208, April.

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