Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial

Authors

  • Macé M. Schuurmans,

    Corresponding author
    1. Department of Internal Medicine, University of Stellenbosch, Cape Town, South Africa
      M. Schuurmans
      Department of Internal Medicine
      University of Stellenbosch
      Clinical Building
      Francie van Zijl Drive
      7505 Tygerberg
      Cape Town
      South Africa
      Tel: 27 21 9389556
      Fax: 27 21 9317442
      E-mail: maceschuurmans@yahoo.com
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  • Andreas H. Diacon,

    1. Department of Internal Medicine, University of Stellenbosch, Cape Town, South Africa
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  • Xandra Van Biljon,

    1. Department of Internal Medicine, University of Stellenbosch, Cape Town, South Africa
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  • Chris T. Bolliger

    1. Department of Internal Medicine, University of Stellenbosch, Cape Town, South Africa
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M. Schuurmans
Department of Internal Medicine
University of Stellenbosch
Clinical Building
Francie van Zijl Drive
7505 Tygerberg
Cape Town
South Africa
Tel: 27 21 9389556
Fax: 27 21 9317442
E-mail: maceschuurmans@yahoo.com

ABSTRACT

Aims  To determine whether 2-week pre-treatment with transdermal nicotine influences withdrawal symptoms or success rate of subsequent smoking cessation using nicotine patches.

Design  Randomized controlled trial.

Setting  Smoking cessation clinic.

Participants  Healthy smokers (n = 200, 45% female) were allocated randomly to either active nicotine-patch (AP, 15 mg daily, n = 100) or placebo-patch (PP, n = 100) pre-treatment. Baseline characteristics were well balanced except for daily cigarette consumption: mean (± SD) 23.1 (8) and 26.4 (11) for AP and PP groups, respectively (P = 0.021).

Intervention  At the screening visit (− 2 weeks) subjects were counselled and started pre-treatment with daily patches (AP or PP). From the quit date (week 0) onwards all subjects received active nicotine patches for 12 weeks (15 mg daily for 8 weeks, 10 and 5 mg daily for 2 weeks each) and counselling.

Measurements  Follow-up visits included measurement of exhaled carbon monoxide at the quit date, 2, 6, 10 and 26 weeks. Subjects documented daily cigarette consumption and severity of withdrawal symptoms (Wisconsin scale) from − 2 weeks to week 2. Outcome measures were withdrawal symptoms composite score and abstinence rates.

Findings  There was no significant difference in withdrawal symptoms, but more subjects in the AP group were smoke-free during the 6-month study period. Overall sustained abstinence was documented in 17% of subjects at 6 months; 22% and 12% for AP and PP, respectively (P = 0.03). Retrospective subgroup analysis showed for subjects smoking >16 cigarettes/day sustained cessation rates were 22% and 9% for AP and PP, respectively (P = 0.01). No difference in adverse event rates was observed.

Conclusions  Nicotine patch pre-treatment before cessation did not reduce early withdrawal symptoms but increased sustained abstinence rates at 6 months. The nicotine pre-treatment was equally effective in light and heavy smokers.

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