Richard R Clayton

I would like to ask a domain question: what is a comprehensive behavioural smoking cessation programme? Those terms are used by the US Food and Drug Administration (FDA) for both Nicorette and for the patches. What are the minimal elements and criteria for designation as a comprehensive behavioural smoking cessation programme? Is it appropriate to treat nicotine withdrawal in the absence of a comprehensive behavioural smoking cessation programme?

The first place to look for an answer to these questions is the product patient instructions because that is where many patients get their information about smoking cessation. The instructions for Nicorette are quite clear: Nicorette is indicated as a temporary aid to the cigarette smoker seeking to give up his or her smoking habit while participating in a behavioral modification program under medical or dental supervision. The efficacy of Nicorette as an aid to smoking cessation was demonstrated in clinical studies, which showed that Nicorette gum in comparison to controlled chewing gums increased the likelihood of smoking cessation among participants in behavioral modification programs. As used in the context of this labeling, behavioral modification refers to supervised programs of education, counseling and psychologic support. The efficacy of Nicorette use without concomitant participation in a behavioral modification program has not been established.

The instructions for the patches are similar: Patch treatment is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. Patch treatment should be used as part of a comprehensive behavioral smoking cessation program. The success or failure of smoking cessation depends heavily on the quality, intensity and frequency of supportive care. Patients are more likely to quit smoking if they are seen frequently and participate in formal smoking cessation programs.

Given the emphasis put by the FDA on comprehensive behavioural smoking cessation programmes, I believe …