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NICOTROL® NS Clinical Studies (nicotine)

CLINICAL TRIALS

The efficacy of NICOTROL NS therapy as an aid to smoking cessation was demonstrated in three single-center, placebo-controlled, double-blind trials with a total of 730 patients. One of the trials used NICOTROL NS with individual counseling while the other two used group support. Patients with severe or symptomatic cardiovascular disease, hypertension, asthma, diabetes or severe allergy were not included in the studies. The amount of NICOTROL NS used was left to the discretion of each patient, with a minimum dose of 8 mg/day and a maximum dose of 40 mg/day.

In all three studies, the recommended duration of treatment was 3 months; however in two of these trials, 241 patients were permitted to continue to use the product for up to 1 year, if they wished. Among the 64 patients abstinent from cigarettes at the end of a year, 23 (36%) were still using the spray, and probable dependence on the spray was seen in several patients (See DRUG ABUSE AND DEPENDENCE).

Quitting was defined as total abstinence from smoking for at least 4 weeks. The "quit rates" are the percentage of all persons initially enrolled who continuously abstained after week 2 or 4.

In all three studies, NICOTROL NS was more effective than placebo at 6 weeks, 3 months, 6 months, and 1 year. The two studies where NICOTROL NS could be used for more than 6 months did not have a better outcome at 1 year than the study in which NICOTROL NS was discontinued at 6 months.

Table 3: Quit Rates by Treatment (N=730 smokers in 3 Studies)
GroupSize (n)At 6 WeeksAt 3 MonthsAt 6 MonthsAt 1 Year
NICOTROL NS36949–58%41–45%31–35%23–27%
Placebo36121–32%17–20%12–15%10–15%

Patients treated with NICOTROL NS had more relief of the urge to smoke and withdrawal symptoms compared with placebo-treated patients.

NICOTROL NS allows the patient to vary the dose of nicotine on a short-term basis. As with other variable dose smoking cessation products, NICOTROL NS may be useful in the management of highly dependent smokers.

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