EA004718B1 - Method for reducing or eliminating smoking - Google Patents

Abstract

1. A method of gradually reducing or eliminating an individual's tobacco usage habit, comprising the step: (a) administering an alternative nicotine source in the form of a transdermal patch comprising a nicotine substance once a day for a predetermined period of time, wherein the predetermined period of time the individual continues to use tobacco but significantly reduces tobacco usage; (b) administering a second alternative nicotine source in the form of a transdermal patch comprising a nicotine substance once a day for a second predetermined period of time, wherein the second predetermined period of time the individual uses no tobacco; wherein second alternative nicotine source comprises a higher nicotine substance dosage than the first alternative nicotine source. 2. The method of claim 1 wherein the first predetermined period of time is substantially 2 to 3 weeks in length. 3 The method of claim 1 wherein the first predetermined period of time the individual reduces tobacco usage by about 33% or more. 4. The method of claim 1 wherein the first predetermined period of time the individual reduces tobacco usage by about 50% or more. 5. The method of claim 1 wherein the first predetermined period of time the individual reduces tobacco usage by about 67% or more. 6. The method of claim 1 or 2 wherein step (a) comprises two or more predetermined periods of time wherein the nicotine substance dosage in the alternative nicotine source and/or the reduction in tobacco usage is varied between the predetermined periods of time. 7. The method of claim 9 wherein step (a) comprises (a) two predetermined periods of time wherein a first such period tobacco usage is reduced by about 50% and the transdermal patch comprises about 14 mg nicotine dosage, and wherein the second such period the new level of tobacco usage is maintained or further reduced and the transdermal patch comprises about 14 mg nicotine dosage; or (b) three predetermined periods of time wherein a first such period tobacco usage is reduced by about 33% and the transdermal patch comprises about 7 mg nicotine dosage, wherein the second such period tobacco usage is reduced by about 67% and the transdermal patch comprises about 14 mg nicotine dosage, and wherein the third such period tobacco usage is maintained at the new level or further reduced and the transdermal patch comprises about 14 mg nicotine dosage. 8. A method of any of the preceding claims wherein the nicotine substance is nicotine. 9. A method of gradually reducing or eliminating an individual's tobacco usage habit, comprising the steps of: (a) administering a first alternative nicotine source in the form of a transdermal patch comprising a nicotine substance once a day for a first predetermined period of time, wherein the first predetermined period of time the individual significantly reduces tobacco usage; (b) administering the first alternative nicotine source once a day for a second predetermined period of time, wherein the second predetermined period of time the individual further reduces tobacco usage; (c) administering a second alternative nicotine source in the form of a transdermal patch comprising a nicotine substance once a day for a third predetermined period of time, wherein the second alternative nicotine source comprises a higher nicotine substance dosage than the first alternative nicotine source; (d) administering a third alternative nicotine source in the form of a transdermal patch comprising a nicotine substance once a day for a fourth predetermined period of time, wherein the third alternative nicotine source comprises substantially the same nicotine substance dosage as the first alternative nicotine source; and (e) administering a fourth alternative nicotine source in the form of a transdermal patch comprising a nicotine substance once a day for a fifth predetermined period of time, wherein the fourth alternative nicotine source comprises a lower nicotine substance dosage than the first alternative nicotine source; wherein during the third, fourth and fifth predetermined periods of time the individual uses no tobacco. 10. A method according to claim 9 wherein the nicotine substance in steps (a) (e) is nicotine. 11. A method according to claim 10 wherein: the first transdermal patch comprises about 14 mg nicotine dosage, the second transdermal patch comprises about 21 mg nicotine dosage, the third transdermal patch comprises about 14 mg nicotine dosage, and the fourth transdermal patch comprises about 7 mg nicotine dosage. 12. A method according to any of claims 9-11 wherein: the first predetermined period of time is substantially 1 week in length; the second predetermined period of time is substantially 1 week in length; the third predetermined period of time is substantially 6 weeks in length; the fourth predetermined period of time is substantially 2 weeks in length; and the fifth predetermined period of time is substantially 2 weeks in length. 13. A method according to any of claims 9-12 wherein during the first to the fifth predetermined periods of time the individual addresses the social and psychological reasons for smoking. 14. A method according to any of claims 9-13 wherein during the first predetermined period of time, the individual reduces tobacco use by about 33% or more. 15. A method according to any of claims 9-13 wherein during the first predetermined period of time, the individual reduces tobacco use by about 50% or more. 16. A method according to any of the claims 9-13 wherein during the second predetermined period of time, the individual reduces tobacco use by about 66% or more. 17. A method according to any of the preceding claims in which the tobacco usage is smoking. 18. A method according to any of the preceding claims in which the tobacco usage is the use of a form of smokeless tobacco.

Description

The present invention relates to a method of gradually reducing or stopping a person’s habit of using tobacco, in particular smoking, as well as the concomitant nicotine addiction resulting from tobacco use, using an alternative source of nicotine in the form of a transdermal (skin-acting) patch. In the past 20 years, a strategy to reduce smoking, up to its cessation, has been used in developing ways to stop smoking. However, the reduction of smoking, as the ultimate goal or as a means to stop smoking, has received insufficient attention in recent years. These methods are not even included in the methods of medical and research centers of health authorities (ANSRK.) And in the Guidelines for Smoking Cessation - an authoritative review of standard smoking cessation techniques. See the publication of the Ministry of Health and Welfare of USA. No. 96-0692 dated April 1996.

Fundamentally new methods of reducing or quitting smoking, essentially, is not created. Most smoking cessation methods relate to quitting smoking methods and are undertaken without the use of pharmacological or behavioral therapy, in part because smoking cessation strategies associated with such therapeutic methods are not consistent with the smoking method preferred by smokers. Recent surveys of smokers on smoking cessation show that many smokers want to quit, but instead of quitting sharply, they would prefer to gradually reduce the number of smoked tobacco products. Recent studies have demonstrated that gradual reduction strategies can lead to success without pharmacological therapy. These strategies, however, include intensive behavioral intervention and the end goal is always to stop, not just to reduce smoking. For example, see Οηοίπρίηί e! a1., Tye Eyesy οί 8shokshd 8seybіle5 οη Sekkayop Oi1soe: Sap \ Ue 1shrtoye op Sosshop Me1yob8 οί Otabia1 Apb Aghir! H1Soipa HUCSebppuakoitpa1 οί SopkiShpd app S11shsa1 R8usyo1odu, Vo1. 63, Bo.3, pp. 388-399 (1995), where two methods of phasing out smoking are compared to throwing “once and for all”. The methods of phasing out smoking, described by the Shift, are! A1., include (1) gradually increasing intervals between cigarettes smoked and (2) gradually reducing the number of cigarettes smoked without changing the interval between smoking. All methods include behavioral behavioral education aimed at preventing relapse, and do not include pharmacological therapy, such as using an external source of nicotine.

Such attempts to quit smoking by gradually reducing the amount of tobacco smoked without replacing nicotine are often unsuccessful. It was shown that such failures of the gradual reduction method are caused by the fact that smokers gradually lose their nicotine and, therefore, have a craving for nicotine and withdrawal, which prevents them from quitting or further reducing smoking.

One method that combines smoking reduction with nicotine replacement therapy is described in US Pat. No. 5,055,478. One embodiment of the method described in this patent involves a stage in which the moments at which each cigarette is smoked are recorded for approximately 2 weeks. Periods of smoking are called “periods of consumption,” which do not necessarily follow each other continuously. Then, tobacco consumption is gradually reduced, replacing within 2 weeks an increasing number of consumption periods (up to 16 periods) of tobacco with an alternative source of nicotine, for example, Motseye® chewing gum containing nicotine (nicotine dosage 2 mg), until the tobacco consumption is stopped. Nicotine in each chewing gum plate is a substitute for all tobacco used during the period of consumption. This level of consumption of an alternative source of nicotine is maintained for about 4 weeks. During this four-week period, when a person still receives nicotine from an alternative source, he works on the social and psychological causes of smoking. After this four-week period, nicotine intake from an alternative source is reduced at a rate of 1 weekly consumption period for about 14-16 weeks until complete cessation of nicotine intake from an alternative source.

The second method, described in US Patent No. 5,055,478, includes the initial stage of registering for about 2 weeks the moments of tobacco consumption by a person to determine the time when a person takes tobacco, and the amount of tobacco consumed during these periods. Then every day it is divided into periods of consumption equal to 1 hour. Then, any consumption of tobacco stops abruptly and an alternative source of nicotine is prescribed for about 2 weeks (approximately 1.5-1.75 mg per consumption period). As in the first method above, after quitting smoking, but while a person is taking nicotine from an alternative source, the person is working on the social and psychological causes of smoking. Then, a person gradually reduces the use of nicotine from an alternative source to a dose of 1 mg over a period of consumption of 10-18 days. This is achieved by prescribing lower doses of nicotine from an alternative source for an ever-increasing number of periods of consumption until a lower dose is taken during all periods of consumption. After achieving this dose reduction in all periods of consumption, this nicotine intake from an alternative source is maintained for approximately 2 weeks. Then, the user gradually stops taking nicotine from an alternative source, reducing the number of daily consumption periods (one per week) until the complete cessation of nicotine intake from an alternative source.

Another method, closely related to the methods described in US Patent No. 5,055,478, combines smoking reduction with the use of nicotine replacement therapy. This method is described in Soreg c1 a1. Νην Norae Неοτ Neauu 8toketk - TNe Cooreg / S1a1op Me11yub 1o 81or 8tookd. In this method, after the initial two-week registration phase, an alternative source of nicotine is introduced for all consumption periods and the smoker stops smoking immediately. The rest of the method is similar to that described above, except that nicotine consumption from the replacement source is reduced to a maintenance level of approximately one third of the first maintenance level, after which a gradual reduction is carried out, as in the first phase described above. In this way, a person receives intensive individual psychological assistance.

Already one way to quit smoking is described in the publication of the company 8TYNK1te VeesNat Msogee® SottSeb OyShekk ¹ ™ Satechb apb 8toktdSekkayop 8guyuye According to this method, a person abruptly stops smoking and takes one Moteyeye® chewing gum plate (2 or 4 mg, the generic name is nicotine-containing polacrilex chewing gum) every 1-2 hours, taking no more than 24 plates per day for 6 weeks. In the seventh week, a person reduces the reception of chewing gum to one plate every 2 hours, and this level of consumption is maintained for 3 weeks. The tenth week of chewing gum is reduced to one plate every 4 hours. At the end of 12 weeks, the use of Mstayeye® chewing gum is stopped. During the twelve-week period, a person records the number of chewing gum discs taken and plans some daily activity that helps to avoid smoking. The calendar provides useful tips on combating smoking and on the psychological aspects of quitting smoking.

The present invention provides an improved method for reducing or stopping tobacco consumption, in particular smoking and eliminating nicotine addiction associated with tobacco consumption, comprising the step of gradually reducing human consumption of tobacco over a period of time, replacing nicotine contained in tobacco with nicotine from an alternative source in the form of transdermal plaster.

Detailed Description of the Invention

As described herein, the invention provides a method for reducing or eliminating a person’s tobacco use habits, in particular smoking, as well as nicotine addiction accompanying this habit. This method includes a stage in which gradually reduce the consumption of tobacco over a period of time, until a person substantially reduces or ceases the use of tobacco. Reduction or cessation of tobacco use is achieved with or without a behavioral intervention, using nicotine replacement therapy, such as a nicotine-containing transdermal patch, in combination with a gradual reduction in tobacco consumption. Such a strategy extends the use of nicotine replacement therapy - from abrupt cessation of tobacco use to a gradual reduction. Gradually reducing the number of cigarettes smoked or other nicotine-containing products used when replacing nicotine contained in tobacco with nicotine from an alternative source, such as a nicotine-containing transdermal patch, helps to cope with nicotine and withdrawal, thereby contributing to the reduction or cessation of tobacco use.

The methods of the invention are intended for use in reducing and / or stopping the consumption of tobacco products, including smoking articles, such as cigarettes and cigars, as well as non-smoking tobacco products, such as chewing tobacco and snuff.

An alternative source of nicotine is in the form of a transdermal patch comprising a nicotine substance. An alternative source of nicotine transdermally introduces a dose of nicotine substance that helps reduce the craving for tobacco use and withdrawal syndrome.

In the present description, the term nicotine substance means nicotine, a substance equivalent to or approaching nicotine, including all and any known compounds and compositions, such as lobeline sulphate, which give a physiological effect similar to nicotine, or mixtures thereof, which give a physiological effect similar to nicotine. .

Preferably, the nicotine substance is nicotine.

Transdermal patch, known in medicine, can easily be adapted by known methods for use in the present invention. Transdermal patches suitable for use in the present invention include those described in US Pat. Nos. 5,004,610; 5,342,623;

5,344,656; 5,364,630; 5,462,745 and 5,508,038. A preferred transdermal patch contains from about 7 mg to about 21 mg nicotine. For use in the method of the present invention, transdermal patches preferably contain dosages of about 7, about 14, and about 21 mg of nicotine. Preferred transdermal patches are patches used in the nicotine transdermal system, manufactured by ParatyColes Veesyat, Pittsburgh, Pa., Under the trade name SC. Such patches contain a copolymer of ethylene vinyl acetate, polyisobutylene and high density polyethylene between colored and transparent polyester substrates. Other suitable patches are described in US Pat. Nos. 5,077,104; 5,268,209; 4,908,027; 5,633,008; 4,839,174; 4,943,435 and 5,167,242. Generally, transdermal patches are used in accordance with standard procedures, for example, they are applied to dry, clean and hairless skin, worn for 24 hours and can be removed overnight (after 16 hours of wearing), and the next morning a new adhesive is stuck. Old patches are removed, and new patches are applied daily at about the same time.

The method according to the invention involves a stage in which gradually reducing the consumption of tobacco over a period of time, while simultaneously replacing nicotine that comes with tobacco, nicotine from an alternative source in the form of a transdermal patch. Levels and patterns of reducing tobacco use, the period of time during which a reduction occurs, and nicotine intake from an alternative source can be adjusted, for example, to take into account differences in the individual use of tobacco and / or preferences of a person regarding such a reduction. People undergoing treatment, preferably during treatment, seek to eliminate the social and psychological causes of tobacco consumption.

In an embodiment, the method of the invention provides for the stage (a) of introducing an alternative nicotine source in the form of a transdermal patch containing a nicotine substance once a day for the first predetermined period of time, where in the first predetermined period of time a person significantly reduces tobacco consumption (which can name the contraction phase), and possibly (b) the introduction of a second alternative nicotine source in the form of a transdermal patch containing the nicotine substance once a day during s second predetermined period of time, the second alternative nicotine source preferably contains a higher dose of nicotine-containing substance than the first alternative nicotine source, wherein the second predetermined period of man does not consume tobacco (which may be called phase cast or termination phase).

In the method according to the invention, the duration of predetermined periods of time, the dosage of the nicotine substance and the reduction of tobacco consumption before quitting can be adjusted, for example, to take into account differences in the patterns of tobacco use by people and / or people's preferences regarding the period allowed for reducing or stopping tobacco consumption.

The first specified period of time (phase reduction) preferably has a duration of about 2-3 weeks. At this time, the person preferably reduces tobacco consumption by about 33% or more (i.e., 3 or more), more preferably by about 50% or more (i.e., ½ or more) or about 67% or more (i.e., 2/3 or more) (the indicated percentages or reduction rates refer to the average tobacco consumption at the start of treatment). The transdermal patch used during this period is chosen to reduce the craving for tobacco and to overcome abstinence. In preferred embodiments, the transdermal patch used in the contraction phase has a nicotine dosage of about 7 mg or about 14 mg, preferably about 14 mg.

In preferred embodiments, the reduction phase consists of two or more predetermined periods of time when the dosage of the nicotine substance in the alternative nicotine source and / or reduction in tobacco consumption varies between the predetermined periods of time. For example, when the nicotine substance is nicotine, the reduction phase may contain (a) two predetermined periods of time, and in the first such period tobacco consumption is reduced by about 50%, and the transdermal patch contains about 14 mg of nicotine, and in the second period this new level is maintained tobacco consumption, or it is further reduced and the transdermal patch contains about 14 mg of nicotine, or (b) three prescribed periods of time, and in the first such period, tobacco consumption is reduced by about 33%, and the transdermal The second patch contains about 7 mg of nicotine, in the second such period, tobacco consumption is reduced by about 67%, and the transdermal patch contains about 14 mg of nicotine, and in the third such period, tobacco consumption is maintained at this new level or reduced even more, and the transdermal patch contains about 14 mg of nicotine; or (c) three prescribed periods of time, with the first such period reducing tobacco consumption by about 33%, and the transdermal patch contains about 14 mg of nicotine, in the second such period, tobacco consumption is reduced by about 67%, and the transdermal patch contains about 14 mg nicotine, and in the third period tobacco use is maintained at this new level or reduced even more, and the transdermal patch contains about 14 mg of nicotine.

In the phase of termination, a person stops consuming tobacco with the support of nicotine replacement therapy in the form of a transdermal patch, which includes a nicotine substance. Nicotine replacement therapy is preferably chosen so as to gradually help a person to get rid of nicotine addiction. The discontinuation phase typically includes a predetermined period of time when a transdermal patch is administered with a relatively high dose of a nicotine-containing substance, for example, about 21 mg of nicotine, followed preferably by at least one predetermined period of time during which a lower dosage of nicotine substance is administered, for example about 7 or about 14 mg. The number of specified time periods and their duration, as well as the dosage of the nicotine substance can vary according to the individual needs or preferences of the person in relation to getting rid of dependence on tobacco and nicotine. The phase of termination usually lasts 8-12 weeks, more often, in essence, about 10 weeks. Typically, a relatively high dose of nicotine substance is prescribed (administered) for a given period, which is essentially about 6 weeks, after which one or more reduced doses of nicotine substance are administered for a total specified period, essentially from about 2 to 4 weeks.

When the nicotine substance is nicotine, in the termination phase, the person preferably uses transdermal patches with a dose of 21 mg nicotine for a given period of about 6 weeks, after which uses transdermal patches with a dose of 14 mg of nicotine for a given period of about 2 weeks, after which it uses transdermal patches with a dose of 7 mg of nicotine for a given period of about 2 weeks.

The person preferably removes the social and psychological causes of tobacco use during one or two phases, preferably in both phases - reducing and stopping tobacco use.

In a preferred embodiment, the method of the invention comprises the steps of (a) introducing a first alternative nicotine source in the form of a transdermal patch containing the nicotine substance once a day for the first predetermined period, and in the first predetermined period the person significantly reduces tobacco consumption, alternative nicotine source once a day for the second predetermined period, and in the second predetermined period the person maintains the level of tobacco consumption achieved by tadii (a), or further reduce tobacco use, (c) introducing a second alternative nicotine source in the form of a transdermal patch containing a nicotine substance once a day for a third predetermined period, with the second alternative nicotine source containing a higher dose of nicotine substance, than the first alternative nicotine source, (6) the introduction of the third alternative nicotine source in the form of a transdermal patch containing a nicotine substance, once a day for four specified third period, with the third alternative nicotine source containing essentially the same dose of nicotine substance as the first alternative nicotine source, and (e) introducing a fourth alternative nicotine source in the form of a transdermal patch containing the nicotine substance once a day for of the fifth specified period, the fourth alternative nicotine source containing a lower dose of the nicotine substance than the first nicotine source, and during the third, fourth and fifth For a given period, a person does not use tobacco.

In a preferred embodiment, the nicotine substance in each of the steps (a) - (e) is nicotine. Most preferably, the first transdermal patch contains a dose of nicotine of about 14 mg, the second transdermal patch - about 21 mg, the third - 14 mg, and the fourth - about 1 mg.

Preferably, the first predetermined specific period is 1 week, the second predetermined period is 1 week, the third predetermined period is 6 weeks, the fourth predetermined period is 2 weeks and the fifth predetermined period is 2 weeks. A person undergoing a course of treatment preferably removes the social and psychological causes of tobacco use during the first and up to the fifth specified period, inclusive.

During the first predetermined period, the person preferably reduces tobacco consumption by about 50% or more of the average tobacco consumption at the time the treatment is started.

During the second predetermined period, the person preferably maintains the newly achieved level of tobacco use or additionally reduces tobacco consumption by about 67% or more from the level of consumption at the time the treatment starts.

Alternatively, an alternative nicotine source in the form of a transdermal patch is administered to the smoker, with the smoker receiving the following instructions.

(a) (Week 1) On days 1 through 7, use a 14 mg transdermal patch and start reducing the number of cigarettes you smoke. By 7th day to achieve a 50% reduction in the number of cigarettes smoked.

(b) (Week 2) On days 8 through 14, continue to wear 14 mg of patch; continue to reduce the number of cigarettes smoked this week and prepare for a complete cessation of smoking.

(c) On the 15th day, stop smoking completely. Go for 21 mg patches. Do not smoke, regardless of whether the goal is set to reduce smoking. For best results, apply 21 mg of patch in the morning to quit smoking. For 6 weeks, continue to wear 21 mg patches to reduce cravings for smoking and completely refrain from smoking.

(b) (Week 9) On week 9, switch to 14 mg patches, thereby reducing the dose of nicotine produced. This is the period of taking a low dose of nicotine, which, nevertheless, reduces the craving for tobacco. Use 14 mg patches for 2 weeks.

(e) (Week 11) On week 11, switch to 7 mg patches to further reduce nicotine intake. Use 7 mg patches for 2 weeks to completely eliminate nicotine addiction.

During the 12-week period, while the person is still receiving nicotine from an alternative nicotine source, the person must eliminate the social and psychological causes of smoking.

Also during this 12-week period, a person applies special tools to track and encourage progress in reducing and quitting smoking. For example, at the beginning of week 1, a person determines a goal to be achieved in a week, reducing the number of cigarettes smoked, and keeps daily entries in the calendar, tracking progress made. This calendar preferably indicates a planned reduction in the number of cigarettes smoked per day during the first 2 weeks of treatment, the level of tobacco consumption is monitored up to the date of smoking cessation, noted every day when a patch is used to reduce cravings for smoking, an indication of their number and intensity (for example, on a five-point scale) after the start of using the patch, as well as the dosage of the patch used. The calendar preferably indicates the phase of the treatment program, for example, a reduction (week 1), a continuation of the reduction (week 2), a cessation (week 3), a suppression of the smoking habit (weeks 4-10), a release from nicotine addiction (weeks 11-12). The calendar may contain useful tips on combating smoking and describe the psychological aspects of quitting and / or reminders of the time devoted to quitting smoking. To mark key dates in the personal calendar, stickers (stickers) are used, which indicate the phase (according to the concept or another) and the dosage of the patch. These products and tools, such as a calendar and stickers, preferably have a color code indicating the phase of the treatment program.

Other tools that can be used in treatment include cards that can be distributed to friends and family members, etc., which support their efforts to reduce or stop the use of a person; lists of reasons to quit smoking; smoking prevention tips; tips on reducing tobacco use and / or a container, such as a tobacco storage box, which is planned to be used in the reduction phase during the 1st and 2nd week.

The present invention also relates to a method for reducing tobacco consumption without necessarily ending such consumption. In this embodiment, after the person reaches the desired level of tobacco consumption, he continues to consume the desired amount of tobacco, while continuing to use an alternative nicotine source in the form of a transdermal patch with a specific dose. For example, if a person reduces smoking to 4 cigarettes per day and uses a patch with a dose of 7 or 14 mg once a day, the person can continue to maintain this regimen. Of course, this alternative does not exclude the possibility of starting a complete cessation of tobacco consumption immediately after reaching the goal of reducing tobacco consumption, or allows maintaining the reduced tobacco consumption regime for some time, and then continue this method according to the above options to completely stop using tobacco .

The above methods are particularly suitable for modern smokers who face intolerance to smoking, for example, at work, where smoking is prohibited. The changing attitude of society towards smoking forces smokers to use tobacco less and less, often in an inhospitable environment. The constant increase in the use of alternative sources of nicotine used in the methods described above reduces the urge to smoke, naturally occurring during the intervals between smoking. Reduced cravings make it easier for a smoker to fulfill a plan compared to completely eliminating tobacco use or using an alternative source of nicotine only during periods of consumption that are separated in time.

When implementing the methods of the invention, the person does not need detailed instructions, he can be given only a brief memo listing the above stages. Thus, the proposed methods seek to overcome the drawbacks of the known methods by providing effective nicotine replacement therapy for gradually reducing or stopping tobacco consumption without intensive personal contact with a consultant or psychologist.

The above description of the invention is presented for purposes of illustration. It is not exhaustive and does not limit the present invention to the described variants and stages. In the light of the concepts described, its various modifications and changes are possible. The above options are presented to illustrate the principles of the present invention and their practical application in order to enable the average person to use different versions of the present invention and various modifications depending on the specific conditions. All such modifications and changes are within the scope of the present invention, which is defined by the appended claims.

Claims (18)

CLAIM 1. A method for the gradual reduction or cessation of tobacco use by a person, comprising the step of (a) daily administering an alternative nicotine source of nicotine in the form of a transdermal patch containing nicotine substance for a predetermined period, wherein during this predetermined period, the person continues to consume tobacco, but substantially reduces it consumption; (b) daily administration of a second alternative nicotine source in the form of a transdermal patch containing nicotine substance, during a second predetermined period, wherein the person does not consume tobacco in this second predetermined period, wherein the second alternative nicotine source contains a higher dose of nicotine substance than the first alternative nicotine source. 2. The method according to claim 1, in which the first predetermined period is 2-3 weeks. 3. The method according to claim 1, in which in the first predetermined period, the person reduces tobacco consumption by about 33% or more. 4. The method according to claim 1, wherein in the first predetermined period, the person reduces tobacco consumption by about 50% or more. 5. The method according to claim 1, wherein in the first predetermined period, the person reduces tobacco consumption by about 67% or more. 6. The method according to claim 1 or 2, in which stage (a) comprises two or more predetermined periods, where the dosage of the nicotine substance in the alternative nicotine source and / or the reduction in tobacco consumption varies between these predetermined time periods. 7. The method according to claim 6, in which stage (a) includes (a) two predetermined periods, moreover, in the first such period, tobacco consumption is reduced by about 50%, and the transdermal patch contains a dose of about 14 mg of nicotine and in the second such period or reduce this new level of tobacco consumption, and the transdermal patch contains a dose of about 14 mg of nicotine or (b) three preset periods, with the tobacco consumption reduced by about 33% in the first such period and the transdermal patch contains about 7 mg of nicotine, in the second such a period of sweat tobacco exposure is reduced by about 67%, and the transdermal patch contains a dose of about 14 mg of nicotine and in the third such period, the level of tobacco consumption is maintained at the achieved level, and the transdermal patch contains a dose of about 14 mg of nicotine. 8. The method according to any preceding paragraph, in which the nicotine substance is nicotine. 9. A method for gradually reducing or stopping tobacco use in humans, comprising the steps of (a) daily administering a first alternative nicotine source in the form of a transdermal patch containing nicotine substance for a first predetermined period, wherein in the first predetermined period, the person substantially reduces tobacco consumption, (b) daily administration of a first alternative nicotine source during a second predetermined period, wherein in the second predetermined period, the person further reduces tobacco fining, (c) daily administration of a second alternative nicotine source in the form of a transdermal patch containing nicotinic substance for a third predetermined period of time, the second alternative nicotine source containing a higher dose of nicotine substance than the first alternative nicotine source, (ά) daily the introduction of a third alternative nicotine source in the form of a transdermal patch containing 13 nicotine substance during the fourth predetermined period a, and the third alternative nicotine source contains a lower dose of nicotine than the second alternative nicotine source, (e) daily administration of a fourth alternative nicotine source in the form of a transdermal patch containing nicotine substance for a fifth predetermined period, and the fourth alternative nicotine source contains less dose of a nicotine substance than the first nicotine source, and during the third, fourth and fifth predetermined periods, the person does not sweat Fucking tobacco. 10. The method according to claim 9, in which the nicotine substance in stages (a) to (e) is nicotine. 11. The method of claim 10, wherein the first transdermal patch contains a dose of about 14 mg of nicotine, the second transdermal patch contains a dose of about 21 mg of nicotine, the third transdermal patch contains a dose of about 14 mg of nicotine and the fourth transdermal patch contains a dose of about 7 mg of nicotine. 12. The method according to any one of claims 9 to 11, wherein the first predetermined period is 1 week; the second set period is 1 week; the third set period is 6 weeks; the fourth preset period is 2 weeks; The fifth preset period is 2 weeks. 13. The method according to any one of paragraphs.9-12, in which during the first to fifth predetermined period, the person eliminates the social and psychological causes of smoking. 14. The method according to any one of claims 9 to 13, wherein during the first predetermined period, the person reduces tobacco consumption by about 33% or more. 15. The method according to any one of claims 9 to 13, wherein during the first predetermined period, the person reduces tobacco consumption by about 50% or more. 16. The method according to any one of claims 9 to 13, wherein during the first predetermined period, the person reduces tobacco consumption by about 66% or more. 17. The method according to any preceding paragraph, in which the consumption of tobacco is smoking. 18. The method according to any preceding paragraph, in which the consumption of tobacco is its consumption not related to smoking.