Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
1999-04-01
2001-02-27
Spivak, Phyllis G. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
active
06194400
ABSTRACT:
FIELD OF THE INVENTION
The present invention is related to the treatment of human beings having various addictions, and the use of specific steroids for that purpose. Particularly, the present invention relates to treatment of nicotine-addicted people.
BACKGROUND OF THE INVENTION
Smoking tobacco has been proven in many case studies to cause cancer, and is linked with many other vascular diseases. Particularly, consumption of nicotine has been associated with arteriosclerosis, heart attacks, cerebral strokes, and various forms of cancer. While it is generally agreed that nicotine, when smoked or otherwise used for non-medicinal purposes, has extremely hazardous effects, the addictive nature of the drug causes many people to continue to use nicotine products to their detriment.
Various treatments have been developed that are designed to aid a person desiring to quit smoking. However, most of these treatments involve administering nicotine to individuals in a form other than a cigar or cigarette. while such a treatment may at times remove the craving for nicotine, these anti-smoking treatments are more harmful to those who continue to smoke during the treatment. Furthermore, the fact that nicotine is being replaced with nicotine provides at best the removal of a habit of lighting a cigar or cigarette and smoking it, but does not provide a relief from the cravings of nicotine. So far, no single effective method has been developed for the treatment of nicotine-addicted humans, and no effective pharmaceuticals have been disclosed.
Many publications are dedicated to the possible effects of the application to DHEA, DHEAS, and precursors of such. For simplicity, the term DHEA, unless otherwise noted, can be interpreted to include DHEAS and analogues and precursors of such as will be defined hereinafter. Some patent publications disclose various therapeutic effects of DHEA. European publication EP-0627921 teaches the use of DHEA as an anti-carcinogen. International publication WO-9416709 teaches the utility of DHEA for treatment of cancer of the uterus. WO-9408589 teaches treatment of lupus erythematosus using DHEA. WO-9494155 teaches the use of DHEA to treat eye diseases. Other scientific publications exist concerning the treatment of breast cancer, and obesity. An article in the Journal of Steroid Biochemistry and Molecular Biology concerned the blood concentrations of twenty different steroids in relation to the concentration of the interneural fluid low affinity interaction of steroids with neuronal membrane-bound receptors.
One study reported that low ESTRIOL and DHEAS levels were noticed in pregnant methadone addicted women (Eur. J. Obstet. Gynecol., vol. 23, p. 67 (1986)). It was concluded in the report that methadone (and probably heroin) use during pregnancy was accompanied by a reduction of circulating DHEAS levels. Although a link seems to exist between DHEA and methadone, there is no suggestion in the article or otherwise that administering DHEA might serve to cure methadone or heroin addiction, or any other addiction for that matter.
It is an object of the present invention to provide a medicinal treatment of addiction to smoking tobacco and any nicotine containing drug. It is a further object of the invention to provide a medicinal treatment of addiction to other substances where the addiction is related to consumption of material or foods that are not naturally part of the human body, such as coffee, tea, alcohol, and various other drugs. It is yet another object of the invention to provide such a treatment without including administration of the very substance to which the human is addicted.
SUMMARY OF THE INVENTION
The above objects and others are met by a method of treating addiction to chemicals and products containing addictive chemicals, which comprises administering to a human in need thereof an effective amount of a pharmaceutical composition which comprises a sex steroid precursor. Addictive chemicals that are applied against according to the present invention include nicotine, caffeine, alcohol, methadone, heroin, cocaine, and subutex. The sex steroid precursor can be any of DHEA, DHEAS, analogues of DHEA, and analogues of DHEAS, as well as compounds that serve as precursors to DHEA and DHEAS in vivo. Examples of analogues of DHEA and analogues of DHEAS comprise (n)-alphafluoroepiandrosterone, and bromoepiandrosterone.
Administering the treatment includes such methods as providing the sex steroid precursor sublingually, or otherwise causing the sex steroid precursor to enter into the bloodstream. The sex steroid precursor may be administered multiple times per day. In a preferred embodiment of the invention, the sex steroid precursor is administered at the times during the day when a person normally desires the addictive chemical.
The above described needs and others are also met by a method of preparing a medicinally effective treatment for addiction to a chemical and products containing the chemical, which includes the steps of extracting a sex steroid precursor from a source where the sex steroid precursor was naturally produced in vivo, and combining an amount of the sex steroid precursor sufficient to effectively treat a human addiction to a chemical and products containing such a chemical, with a pharmaceutically acceptable carrier, excipient, or agent. In the method, the step of combining the sex steroid precursors with a pharmaceutically acceptable agent may include fortifying foodstuff with the sex steroid precursors. The method may also include the step of mixing the sex steroid precursor with one of natrium hydroxybutyrate, and an amino acid containing compound selected from arginine, lysine, ornithine-HCL, and creatine. Other suitable amino acids may be suitable according to the needs of the patient.
As noted before, the addictive chemical includes one or more chemicals selected from the group which comprises nicotine, caffeine, alcohol, methadone, heroin, cocaine, and subutex. Also as noted before, the sex steroid precursor is selected from the group which includes DHEA, DHEAS, analogues of DHEA and DHEAS such as (n)-alphafluoroepiandrosterone, and bromoepiandrosterone.
Similarly, the above described needs and others are met by a method of preparing a medicinally effective treatment for addiction to a chemical and products containing said chemical, which includes the steps of providing at least one synthetically prepared sex steroid precursor, and combining an amount of the sex steroid precursor sufficient to effectively treat a human addiction to a chemical and products containing the chemical, with a pharmaceutically acceptable carrier, excipient, or agent. The step of combining the sex steroid precursors with a pharmaceutically acceptable agent may include fortifying foodstuff with the sex steroid precursors.
The method may further include the step of mixing the sex steroid precursor with at least one of vitamin E, vitamin C, and coenzyme units. Furthermore, the method may include the step of mixing the sex steroid precursor with one of natrium hydroxybutyrate, and an amino acid containing compound selected from arginine, lysine, ornithine-HCL, and creatine.
As in the prior methods, the addictive chemical is one or more chemicals selected from the group which comprises nicotine, caffeine, alcohol, methadone, heroin, cocaine, and subutex. Also, the sex steroid precursor is selected from the group which includes DHEA, DHEAS, and precursors of the compounds such as (n)-alphafluoroepiandrosterone, and bromoepiandrosterone.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The following is a detailed description of the present invention, and how the present invention serves to accomplish the above objects and others. The present invention includes a method of treating addicted human beings and the use of specific steroids for that purpose. Particularly, the invention includes a method for treatment of nicotine-addicted people and the use of sex steroid precursors for that purpose. Accordingly, the present invention includes a method of preventing tobacco and n
Nefkens Gerard J.
Nefkens Helga Manuela
Kananen Ronald P.
Rader, Fishamn & Grauer
Spivak Phyllis G.
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