In October 1991, Transdermal Products International Marketing Corporation, in Bristol, Pennsylvania, began actively seeking cigarette smoking adults to participate in a in-depth research for a stop smoking program. The Objective of the research was to attract both men and women of all ages, with a long-term smoking dependency. Over 600 prospects were interviewed to help determine a representative cross section of smokers. The object of the interviews was to select men and women over the age of eighteen, who were regular smokers who are classified as light (social smokers, less than one pack of cigarettes per day) to heavy smokers (two or more packs of cigarettes per day).

The statistical data gained from the 600 interviews enabled us to determine the protocol for the average male and female cigarette smoker. Our data was then compared with the data published by the United States Surgeon General's office to validate our conclusion.

The amount of published boos and information available concerning cigarette smoking is almost limitless. In establishing the protocol for the "stop-smoking" test program the ten references recorded in the United States Food and Drug Administration's "Smoking Deterrent Drug Products for over-the-counter Human Use", Tentative Final Monograph published July 3, 1985 were reviewed and used as guide lines were relevant.

All candidates for participation in the stop smoking program expressed a sincere desire to quit smoking, an essential common denominator for achieving valid research results. All candidates had a history of smoking for two or more years and admitted to attempting to stop smoking more than once on their own.

The protocol of the program including psychological support from the beginning with group counseling at the start of the program and an on-going "stop-smoking" hot line with a recorded reinforcement message. The objective of the program was to achieve total abstinence. Success of the program would not be real if it achieved only reduction in cigarette consumption. The goal of the program was to determine the number and percentage of participants that would abstain from smoking for a full thirty days while wearing the "Smoke-No-More" transdermal patch.

It is significant to mention that the protocol did not include a double blind test. Each participant was issued thirty patches each containing the prescribed dosage of the active ingredient Lobelia Inflata Herb. The participants were informed that each patch contained the active ingredient and no placebos were distributed.

All of the participants were from the Delaware Valley area of Eastern Pennsylvania and New Jersey. At their original briefing the participants were informed that the smoking habit was psychological as well as physical. Each participant received a sheet containing helpful suggestions on how to overcome some of the well-entranced psychological habits. For example:

1. Keep a record of the number of cigarettes smoked the day before the start of wearing the patch. Then record the number of cigarettes smoked each day while wearing the patch.

2. Enlist the support of family members and co-workers in the campaign to quit smoking cigarettes.

3. Be aware of cigarette smoking situations, e.g., after meals, during coffee breaks, at parties and meetings.

4. Reduce personal and work related stressful situations, which increase and heighten the urge to smoke.

5. Keep a diary of the times of day and the events that create smoking patterns.

6. When the smoking urge is strongest, satisfy that urge by drinking a soft drink or fruit juice, eat a piece of hard candy or chew gum, or simply take deep breaths.

7. Exercise or take long walks are helpful at high stress times.

8. When exercise or walks are not possible, use the hands in various ways, i.e., grasping them together and stretching help reduce the urge and relieves stress.

The original panel of participants numbered one hundred and twenty people. It was anticipated that up to twenty percent of the participants would drop out of the program within the first seven days. Nineteen people dropped out of the program during the first seven days representing a drop out rate of sixteen percent. The nineteen people had many legitimate reasons for dropping out and did not necessarily represent the heaviest smokers.

The following demographics pertain to the participants. All social, economic and occupation groups are represented.
 

 
The following chart represents the results obtained in percentages (%) of the number of the one hundred and one participants in the program who stopped smoking cigarettes and totally refrained from smoking for up to the full thirty days of wearing the patch.  If participants had not abstained completely by the fifteenth day of wearing the patch, they were permitted to continue using the patch, but were considered failures by the protocol of the program.  All of these latter people reported small to significant reduction in their cigarette consumption over the thirty-day period.  Some even abstained after the fifteenth day cut off date.

The motivation to stop smoking is the single most important factor in the wearing of the Smoke-No-More patch.  The  patch is designed to be a “temporary aid to those who want to stop smoking cigarettes.”

The only scientific conclusion for 15% of the women and 14% of the men completely abstained from the smoking habit within the first three days is motivation.  These participants finally found the method that suited their psychological desire to stop smoking.
Others reported that just the act of applying the patch every day helped reinforce their desire to stop smoking cigarettes.  It was determined that those participants who followed the complete guide lines of the program and used the hot line, had the fastest and greatest results.  All participants were encouraged to continue to wear the patch after the first thirty days.  Each were offered free patches.  Without exception all took up to a ninety-day supply of patches.  All the participants who stopped smoking in their first seven days were encouraged to continue to wear the patch.
With a 64% and 61% success rate in just fifteen days, the Smoke-No-More patch must be considered highly successful.  Even considering the nineteen people who dropped out of the program, the patch is over 50% effective, successful, powerful, validly scientific evidence that the patch is an important and effective aid for those who wish to break this deadly habit.

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