Comparative efficacy of 24‐hour and 16‐hour transdermal nicotine patches for relief of morning craving

Abstract
Aims. To compare a transdermal nicotine patch designed for 24‐hour wear with one designed for 16‐hour wear for relief of craving and withdrawal, particularly in the morning hours. Design. Smokers were randomly assigned to use one of two common patch regimens: NicoDerm/NiQuitin (24‐hour wear, 21 mg nicotine) or Nicotrol/Nicorette (16‐hour wear, 15 mg). In a double‐dummy design, participants wore two patches during the day, one active, one placebo and one patch while sleeping. Setting. A smoking cessation research clinic. Participants. Two hundred and forty‐four smokers who suffered morning cravings. Intervention. Two patch formulations approved and marketed for over‐the‐counter use in the US‐ NicoDerm CQ (labeled as 21 mg over 24 hours) and Nicotrol (labeled as 15 mg over 16 hours)‐were each used according to its instructions. Smokers also received behavioral counseling. Measurements. For a week of baseline and 2 weeks after quitting, smokers used palm‐top computers to assess craving and withdrawal symptoms several times each day. Findings. The 21 mg/24‐hour patch yielded consistently better control of craving, not only during the morning hours, but throughout the day, and over the 2‐week period of abstinence. Additionally, the 21 mg/24‐hour patch yielded greater reductions in anxiety, irritability and restlessness. Smokers using the 21 mg/24‐hour dosing regimen also experienced longer abstinence than those using the 15 mg/16‐hour patch. Conclusions. These findings demonstrate that 24‐hour dosing with a 21 mg patch affords superior relief of craving and withdrawal during the first 2 weeks of abstinence, when symptoms are at their peak, and when relapse is most likely. They confirm the importance of dosing parameters in nicotine replacement products.