Randomized comparative trial of nicotine polacrilex, a transdermal patch, nasal spray, and an inhaler.

BACKGROUND There are several nicotine replacement products on the market, and physicians are likely to be asked with increasing frequency about which of these products their patients should use. OBJECTIVE To provide a basis for rational advice by comparing nicotine polacrilex (gum), a transdermal patch, nasal spray, and an inhaler. DESIGN Randomized trial with assessments at the quit date and 1, 4, and 12 weeks later. SETTING Hospital smokers' clinic. PATIENTS Male and female community volunteers (N = 504) smoking 10 or more cigarettes per day and seeking help to stop smoking. INTERVENTIONS Patients were given brief advice, and purchased their nicotine replacement treatment at approximately half the regular retail price. MAIN OUTCOME MEASURES Nicotine replacement treatment use, ratings of withdrawal symptoms, ratings of product characteristics and helpfulness, and biochemically validated continuous lapse-free abstinence. RESULTS The products did not differ in their effects on withdrawal discomfort, urges to smoke, or rates of abstinence. The continuous validated 12-week abstinence rates were 20%, 21%, 24%, and 24% in the gum, patch, spray, and inhaler groups, respectively. Compliance with recommended nicotine replacement treatment use was high for the patch, low for gum, and very low for the spray and the inhaler. The spray was underused because of adverse effects more often than the other products. In the subjects using the spray, the level of use among abstainers at week 1 predicted outcome at week 12. The inhaler was rated as more embarrassing to use than the other products, but provided at least as much nicotine as the gum. CONCLUSION When asked about nicotine replacement treatment products available, physicians should note that, despite low compliance with the recommended dose of the spray and inhaler and differences in product ratings, overall, there are no notable differences between the products in their effects on withdrawal discomfort, perceived helpfulness, or general efficacy.