Summary study NIC-ex SX1

Object of Study

Earlier research showed that application of a low intensity electric current to the brain significantly reduced the physical and psychological symptoms of withdrawal from drug addiction. A clinical randomized, placebo-controlled, double-blind study was completed in January, 2004, at the University Hospital Zurich. The study was designed to evaluate the effectiveness of NIC-ex SX1 brain electric stimulation in reducing the nicotine withdrawal symptoms during a smoke cessation program.

Design of Study

Sixty-four chronic cigarette smoker volunteers, 20 males and 44 females, with a mean age of 42 years, were randomly assigned either to an active device (intervention) group of 31 subjects or an inactive device (placebo) group consisting of 33 subjects. All involved in the study, both the medical clinicians and the subjects, were “blinded” to the treatment (intervention or placebo) condition. The small, portable, fully automated device, programmed for either placebo or nicotine treatment, was applied via electrodes placed behind each ear and electric stimulation delivered (or not) to the brain at a constant low intensity energy and specific low frequency level. All subjects were monitored during the 96-hour treatment period, at which time the device was removed. Follow-up consultations and measurements were conducted at 2 and 6 weeks after the beginning of the treatment and then 3 and 6 months, when the study was completed, and after one year. Measurements included a general checklist of health status and a 6-item scale that assessed the initial nicotine dependence, medication use, smoking status and urine nicotine metabolite (cotinine) levels. A brief 28-item Smoking Withdrawal Scale questionnaire, predictive of smoking cessation, containing seven reliable major symptoms of the nicotine withdrawal syndrome, was used by each participant for daily recording of withdrawal symptoms during the first 2 weeks of the study, and subsequently by the doctor at 6 weeks and by the study nurse at 3 and 6 months.

Summary

The percentage of non-smokers in the intervention group was higher at all time periods (4 days, 2, 6 weeks, 3 and 6 months) studied, compared to the placebo (control) group. The intervention group, after 3 months, had a 51% success rate of quitting smoking compared to the 36% in the placebo group and after 6 months a 42% success rate of quitting smoking compared to the 30% in the placebo group. This is a higher success rate than that reported for smoke cessation methods involving such aids as nicotine replacement, anti-depressants (Zyban) and general practitioners.
The intervention group experienced significantly fewer and less intense total nicotine withdrawal symptoms, compared to the placebo group over all time periods studied. Specifically, the intervention group reported less total physical symptoms, more ability to concentrate, less anxiety and, most importantly, less craving for cigarettes during the critical first seven days of withdrawal.
Thus, the intervention NIC-ex SX1 group enjoyed a higher success rate and remained smoke-free longer compared to the placebo group and compared to other smoke cessation aids currently in use.