The efficacy of nicotine patch therapy has been demonstrated in numerous placebocontrolled trials'-8 and supported by metaanalyses9-'2 and studies of general populations.'3"4 Nicotine patch therapy generally doubles abstinence rates over placebo controls at both short-term (end of patch therapy) and long-term (6 to 12 months) follow-ups.2-8Although safety concems were raised shortly after the introduction ofthe nicotine patch, 15"6 controlled trials2-8 and population survey studies' 134 have not raised any serious safety concerns about nicotine patch therapy. Recent clinical practice guidelines published by the Agency for Health Care Policy and Research recommended the use ofnicotine replacement in smoking cessation by most patients.17Despite the proven efficacy and safety ofnicotine patch therapy, there are significant barriers to its widespread use among smokers.Two substantial barriers to wider use of nicotine patch therapy have been cost and the requirement for a physician's prescription. The requirement for a prescription not only represented an obstacle but also added to the cost of using nicotine patch therapy. It was believed that removing the prescription barrier could encourage more smokers to try to stop smoking by using nicotine patch treatment. Because of this and the demonstrated efficacy and safety of nicotine patch therapy in clinical trials, nicotine patches were released for overthe-counter purchase in 1996.In our 1994 to 1995 study, we attempted to replicate the over-the-counter environment while maintaining regular contact with study subjects to observe and scientifically validate their response to therapy. Our specific aims were to (1) determine the efficacy of 22-mg, 24-hour nicotine patch therapy in an overthe-counter environment for smokers interested in stopping smoking and (2) determine the safety ofnicotine patch therapy when it is used in an over-the-counter setting. MethodsOverview A true simulation of an over-the-counter environment requires that subjects pay for their medication. This causes a dilemma for investigators who wish to perform a placebocontrolled trial in an over-the-counter environment, because it would be unethical to ask volunteer subjects to pay for placebo. In an attempt to overcome this difficulty, we performed 2 parallel over-the-counter smoking cessation trials: a double-blind, placebo-controlled trial of placebo vs 22-mg, 24-hour patch (patches were provided free of charge) and an open label trial of active 22-mg, 24-hour patch therapy in which subjects paid for nicotine patches. (Nicotine patches were supplied by Elan Pharmaceutical Technologies, Athlone, Ireland.) Inclusion and exclusion criteria were identical for both trials, and except for the use of placebo patches in the former trial, all study methods were identical. In this article, the former trial is referred to as the placebo-controlled trial and the latter is referred to as the open label-pay trial. ParticipantsSubjects were recruited, via media advertisements, for participation in a smoking ces-

When the nicotine patch was used in an over-the-counter setting, quit rates were comparable to those reported for medical settings. A 2:1 quit rate advantage was achieved at week 6 and was maintained at 24 weeks.

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Aim: To characterize vaso-occlusive crises (VOCs) and describe healthcare costs among commerciallyinsured, Medicaid-insured, and Medicare-insured patients with sickle cell disease (SCD).

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