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

Aims. To compare a transdermal nicotine patch designed for 24-hour wear wit h one designed for 16-hour wear for relief of craving and withdrawal, parti cularly in the morning hours. Design. Smokers were randomly assigned to use one of two common patch regimens: NicoDerm/NiQuitin (24-hour wear, 21 mg n icotine) or Nicotrol/Nicorette (16-hour wear, 15 mg). In a double-dummy des ign, 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 crav ings. Intervention. Two patch formulations approved and marketed for over-t he-counter use in the US-NicoDerm CQ (labeled as 21 mg over 24 hours) and N icotrol (labeled as 15 mg over 16 hours)-were each used according to its in structions. Smokers also received behavioral counseling. Measurements. For a week of baseline and 2 weeks after quitting, smokers used palm-top comput ers to assess craving and withdrawal symptoms several times each day. Findi ngs. 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 g reater reductions in anxiety, irritability and restlessness. Smokers using the 21 mg/24-hour dosing regimen also experienced longer abstinence than th ose 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 a nd 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.