Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-12-21
2003-10-07
Spivack, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
Reexamination Certificate
active
06630449
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to methods to reduce the desire to smoke, in particular this invention relates to methods to quit smoking, and most particularly, this invention relates to methods to reduce the craving for nicotine after quitting smoking.
2. State of the Art
Smoking is a huge health problem in the United States, and around the world. For example, every year cigarettes kill more Americans than AIDS, alcohol, car accidents, fires, illegal drugs, murder and suicide combined. Having said this, it is known that smoking is a notoriously hard habit to quit. That is because the smoker is addicted to nicotine, that is to say, the biochemistry of his or her body has become chemically dependant on nicotine, the primary alkaloid found in tobacco. It has been said that the chemical dependance formed by nicotine use can be harder to end than that caused by heroin or cocaine. Indeed, reliance on this chemical dependancy seems to have been one of the tobacco companies main marketing strategies for selling cigarettes and other forms of tobacco.
Of course stopping smoking is one of the single most beneficial life style changes a smoker can do to improve health and increase longevity. It is known that smoking decreases lung capacity and function and is known to cause emphysema and has been implicated in many forms of cancer. It also is harmful to the gums, many other organs of the body, and, most notably, the skin—it causes deep wrinkling. This is in addition to administering to the smoker a large dose of carbon monoxide and other toxins which have a cumulative detrimental effect on the smokers over all health.
A variety of techniques have been suggested to alleviate the craving for nicotine while the smoker tries to quit. These include nicotine replacement therapy-nicotine administered as in Nicoderm®, Nicotderm CQ® and Nicorette®, via patches, gum, spray, inhaler, and the like—and dosing with mild antidepressants, for example, Zyban®, and other medications, for example, Clonidine®, Nortriptyline®, administered orally or transdermally. These methods may work for some people for some periods of time, but the highest success rates for these therapies seems to be about 25%, and most reliable data suggests that, for most people given these therapeutic drugs as they normally are, the success rate is less than 10%.
Administration of corticotrophins provides one alternative method to reduce the craving for nicotine. Bourne, in U.S. Pat. No. 4,621,074 and Bourne,
Treatment of Cigarette Smoking with Short
-
term High
-
dosage Corticotrophin Therapy; Preliminary Communication, J. Royal Soc. Med.,
74, 649 (1985), and others, including Tarogovnik, J., Nicotine,
Corticotrophin and Smoking Withdrawal Symptoms Literature review and Implications for Successful Control of Nicotine Addiction; Clin. Ther.;
11, 846 (1989); McElhaney, J.,
Repository Corticotrophin Injections as an adjuct to Smoking Cessation During the Initial nicotine Withdrawal Period; Results from a Family Practice Clinic; Clin. Ther.
11; 851 (1989); and Targovnik, J.,
New Strategies to Achieve Successful Smoking Cessation: Clinical Experience of Five Physicians; Perspectives in Clinical Medicine
(1990) have found that corticotrophins given to smokers intramuscularly tends to dramatically reduce the craving for nicotine in the smokers so treated. At this time, the exact mode of operation is not well elucidated, but it seems that corticotrophins competes with nicotine for some nicotine receptor site, probably in the brain. About seventy two hours after the first administration, the effect of corticotrophins starts to wear off, and the patient experiences a resumption of nicotine craving. The cravings do not last forever, in many people, they are usually gone within about ten days, but they do come and go with varying intensities until they finally desist. The treatment Bourne described was one administration of corticotrophins. In actual use, this will reduce the cravings for nicotine for perhaps thirty or so days, but then thirty to sixty percent of the patients in this kind of study tend to start smoking again. Obviously, for those who never lost their craving for nicotine, continuing not to smoke presents huge problems, that may not be easily solved by the smoker. The problems with smoking resumption in those no longer really chemically addicted to nicotine tend to involve social settings where others are smoking, the belief that smoking helps in a weight reduction regime, and pleasant associations with smoking.
It would be advantageous to have a system of smoking cessation and nicotine addiction care that lasted long enough to cause at least eighty percent or more of the smokers who participate in the study to no longer have any craving for nicotine, and for those who no longer have a craving for nicotine to remain off tobacco, that is, for at least eighty percent of the smoker who participate in a program to quit smoking for good.
SUMMARY OF THE INVENTION
This invention provides a method of reducing the nicotine addiction associated with smoking by a combination of nutrition augmentation, craving reduction, and therapy. The craving reduction is accomplished by administration of corticotrophins and mild relaxants, for example, tryptophan and GABA precursors.
A first aspect of this invention is a method of treating a smoker trying to quit smoking for nicotine addiction comprising:
administering to the smoker at least one antioxidation agent starting on day one and continuing daily for at least the next thirty days;
co-administering to the smoker at least one vitamin starting on day one and continuing daily for at least the next thirty days;
co-administering to the smoker at least some GABA precursor starting on day one and continuing daily for at least the next thirty days;
administering to the smoker an injection of at least some adrenal corticotropin hormone after the administration of an antioxidant; and
administering to the smoker an injection of at least some adrenal corticotrophin hormone between sixty and ninety hours after the first administration.
A second aspect of this invention is a method of treating a smoker trying to quit smoking for nicotine addiction comprising:
administering to the smoker at least one antioxidation agent starting on day one and continuing daily for at least the next thirty days;
co-administering to the smoker at least one vitamin starting on day one and continuing daily for at least the next thirty days;
co-administering to the smoker at least some GABA precursor starting on day one and continuing daily for at least the next thirty days;
having the smoker participate in a smoker aversion therapy session by day two and at least one more interval between three and ten days after the first smoker aversion therapy session;
administering to the smoker an injection of at least some adrenal corticotropin hormone after the administration of an antioxidant; and
administering to the smoker an injection of at least some corticotrophin hormone between sixty and ninety hours after the first administration.
REFERENCES:
patent: 4621074 (1986-11-01), Bourne
patent: 5480651 (1996-01-01), Callaway
patent: 6132754 (2000-10-01), Hudson
Bourne,Treatment of Cigarette Smoking with Short-term High-dosage Corticotrophin Therapy; Preliminary Communication, J. Royal Soc. Med., 74, 649-650, (1985).
Targovnik, J.,New Strategies to Achieve Successful Smoking Cessation: Clinical Experience of Five Physicians; Perspectives in Clinical Medicine, (1990).
McElhaney, J.,Respository CorticotrphinInjections as an adjuct to Smoking Cessation During the Initial nicotine Withdrawal Period; Results from a Family Practice Clinic;Clin. Ther.11; 854-861, (1989).
Tarogovnik, J., Nicotine,Corticotrophin and Smoking Withdrawal Symtoms Literature review and Implications for Successful Control of Nicotine Addiction; Clin. Ther; 11, 846-853, (1989).
Miller Alcinda
Wastchak David
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