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Introduction
Because smoking is so common, and because its complications are so common and so devastating,1 nicotine dependence is the most common serious medical problem in the United States.2,3 Clinical approaches to management of this condition have improved markedly over the past 15 years.3,4 Substantial advances in behavioural therapy have been complemented by the introduction of pharmacological agents that ameliorate nicotine withdrawal. Though these major advances have been enormously useful, substantial research is needed to advance basic knowledge of treatment, to integrate what has already been learnt into daily practice for individuals and in the community, and to inform policies that foster the availability of appropriate treatment where it is needed most. This report focuses on the unanswered policy research questions about using pharmacological adjuncts in managing nicotine dependence.
Background
A number of pharmaceutical companies market and promote nicotine in several forms, as well as drugs similar to nicotine, as adjuncts in the treatment of nicotine dependence. The goal in this arena is the familiar one of producing a safe and effective drug.4–6 Nicotine gum (Nicorette, available in the United States since 1984), various nicotine patches (Habitrol, Nicoderm, Prostep, and Nicotrol, first introduced in the United States in late 1991), and lobeline-containing preparations sold over the counter (such as Ban-Tron, Cigarrest, and Nicoban) are the nicotinic agonists presently on the market for this indication. Nicotine gum and nicotine patches are effective as adjuncts in the behavioural treatment of nicotine dependence. On the other hand, although lobeline has possible peripheral nicotinic actions, activity in the central nervous system has not been shown, and products containing lobeline have no demonstrated efficacy. Other formulations containing nicotine (nasal sprays and vapour inhalers) are under development. In the United States both nicotine gum and nicotine patches are …