WO1993002682A1

WO1993002682A1 - Method and compositions for reducing craving for alcohol and stimulants

Info

Publication number: WO1993002682A1
Application number: PCT/US1992/006519
Authority: WO
Inventors: Daniel W. Tennant
Original assignee: Labco Pharmaceuticals, Inc.
Priority date: 1991-08-06
Filing date: 1992-08-06
Publication date: 1993-02-18

Abstract

Compositions and methods for reducing the craving for alcohol or stimulants are provided which comprises administering to the patient specific combinations of amino acids, vitamins and minerals. A composition for reducing the craving for alcohol is provided which comprises DL-phenylalanine, cysteine, L-glutamine, L-tyrosine, choline along with minerals and vitamins, and a pharmaceutical composition for reducing the craving for stimulants is provided which comprises DL-phenylalanine, L-tyrosine, taurine, and L-glutamine in effective amounts. The compositions are administered to the addicted patients in the form of easy-to-swallow capsules, and the present invention provides a safe, effective and inexpensive way of supplementing treatment centers and counseling programs which are used to promote the recovery of alcoholics and drug addicts. The present system has been successful in increasing the proportion of individuals that will stay in the recovery program, and at the same time provides nutritional benefits to increase the overall health of the patient.

Description

METHOD AND COMPOSITIONS FOR REDUCING CRAVING FOR ALCOHOL AND STIMULANTS

Field of the Invention k The invention relates in general to pharmaceutical i compositions for reducing the craving for alcohol and stimulants, and in particular to compositions comprised of amino acids, vitamins and minerals which- are effective in reducing the craving in humans or animals for alcohol and stimulants such as cocaine or amphetamines.

BACKGROUND OF THE INVENTION

One of the most serious problems facing modern society today is the ever expanding epidemic with regard to drug and alcohol abuse. The problem is one that is not confined to any particular part of society, but actually encompasses all ages and socioeconomic groups. There are no stereotypical addicts, and attitudes regarding the affected person's own state of health will vary widely among different individuals. The one common factor amongst all cases, however, is that most of these individuals will suffer from various diseases and other problems which are directly related to their addiction. Further, many addicts pose a serious danger to society, either due to crimes that are carried out because of an addiction, or due to workplace or motor vehicle accidents caused by intoxicated individuals that often harm innocent victims. In addition, the economic burden that society must take on due ,- to these problems is incalculable.

It has thus been the case that numerous scientific studies have been carried out in an effort to treat or cure drug and alcohol addiction, and to discover the reasons for the addiction. Many of these studies have supported the notion that there is a relationship between nutrition and behavior, and there is evidence showing a connection- between nutritional supplements and successful clinical treatment of drug and alcohol abusers. For example, the dietary profile of alcoholics and drug abusers is most often non-nutritious food and alcohol which generally means that the major nutrients are frequently depleted or out of balance. Since neurotransmitters (the brain's messengers) are based on amino acids, these studies strongly suggest that an amino acid- based therapy can become very important as an adjunct to addiction treatment.. When used in combination with counseling and other programs to treat addiction, amino acid therapy can help in bringing the brain's normal receptors into balance, thereby assisting in the stabilization and recovery of the patient.

It is known in the patent arts to treat addictions or addiction-related illnesses with compositions that include amino acids. For example, U.S. Patent No. 4,761,429 (Blum et al) discloses a composition for reducing craving for alcohol and opiates that includes DL-phenylalanine and D-leucine. Additionally, compositions for treating drug abuse which include a norepinephrine precursor such as L-phenylalanine or L-tyrosine are disclosed in U.S. Patent No. 4,843,071 (Hohenwarter) . Finally, compositions including amino acids which are used in the treatment of liver disorders such as those caused by alcoholism are disclosed in U.S. Patents 4,987,123 (Masaki et al) , 4,792,549 (Takahashi et al) and 4,596,825 (Suda et al) .

In addition to being deficient in essential amino acids, however, it is further the case that alcoholics and drug abusers usually suffer from problems related to vitamin and mineral deficiencies as well. Abusive use of alcohol, for instance, impedes the absorption and utilization of vitamins.

Most often, the water soluble B-complex vitamins are seriously deficient in the alcoholic, especially thiamin. These water soluble B-vitamins are generally concerned with maintenance of tissues in the digestive system, including the liver, skin and the nervous system. Decreased food intake by the alcoholic usually results in serious avitaminosis which then evolves into impaired digestion and absorption of nutrients. Very often, in affected individuals, lipid metabolism is defective, absorption of the fat soluble vitamins is poor, and subsequently vitamin E which is required for cellular health is in extremely short supply. The vitamin deficiencies associated with addiction thus require supplementation to bring a recovering patient to normal.

Additionally, mineral deficiencies in drug and alcohol abusers which arise from various causes are very common. In some cases, overloading of certain minerals causes mineral imbalances such as hyperabsorption of iron. Further, mineral depletion often results from a lack of dietary sources or from electrolyte imbalances. The condition of mineral depletion can result in many serious ailments, such as cardiac arrhythmia due to potassium ion deficiency, dermatitis from zinc deficiency, and a number of other severe problems. It is thus the case that minerals must be supplemented as well in order to maximize clinical treatment of drug and alcohol addicts.

Although various systems which are based on amino acid treatment have shown success in existing programs to treat or cure drug and alcohol addiction, many of these systems are deficient in providing all of the necessary nutritional factors in order to achieve maximum results. It is thus an extremely desirable object to develop compositions comprised of specific combinations of particular amino acids, vitamins and minerals which can be extremely effective in reducing the craving for alcohol and stimulants such as cocaine or amphetamines in humans.

SUMMARY OF THE INVENTION

In accordance with the present invention, pharmaceutical compositions for reducing the craving for alcohol or stimulants in humans and animals are provided which comprise precise blends of high purity amino acids, vitamins and minerals. A pharmaceutical composition for reducing the craving for alcohol is provided which comprises a blend of amino acids, such as DL-phenylalanine, cysteine, L-glutamine, L-tyrosine and choline; minerals including calcium, chromium, magnesium, phosphorous, potassium and zinc; and vitamins including B vitamins and vitamin E. A pharmaceutical composition for reducing the craving for stimulants such as cocaine or amphetamines is provided which comprises a blend of amino acids including DL-phenylalanine, L-tyrosine, taurine and L-glutamine; minerals including calcium, magnesium, zinc, potassium and chromium; and vitamins including B vitamins and vitamin C. In the preferred embodiment, the compositions are utilized in the form of an easy-to-swallow capsule, and in the preferred mode of administration, two of the capsules are ^•taken three times daily. In the preferred method of the invention, the craving for stimulants or alcohol is reduced by administering to the human or animal patient the above compositions in amounts effective to reduce the craving for stimulants or alcohol.

The novel method and compositions of the present invention are specifically designed to restore the extensive nutritional deficiencies and imbalances with regard to vitamins, minerals and proteins in the addicted individual, and this is accomplished using a natural, non-addictive, non- abusable nutr t precursor therapy. The nutritional care • provided by the present invention corrects metabolic deficiencies, and is balanced so that restoration of normal digestive and nutrient absorptive mechanisms is promoted in the addict, and this nutritional regimen, when followed along with counseling or other substance abuse treatment, will greatly aid the recovery of the substance abuser from his addiction.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

According to the present invention, there is provided a system for safely and effectively reducing the craving for alcohol or stimulants which comprises compositions of amino acids, vitamins and minerals and a method for their administration. The compositions and method of the invention are designed to be used in combination with the programs and counseling methods commonly employed in the treatment of drug addicts and alcoholics. The amino therapy of the present invention has been useful in maximizing clinical treatment results and in reducing the drop-out rate of patients in such programs. The present system has been specifically designed to meet the demand for a cost-effective nutritional support product which can be used alongside professional treatment for drug and alcohol abusers.

In a preferred embodiment of the present invention, a pharmaceutical composition for reducing the craving for alcohol in humans or animals is provided which is comprised of the compounds DL-phenylalanine, cysteine, L-glutamine, L- tyrosine, and choline, along with vitamins and minerals, all in amounts effective to reduce craving for alcohol. This composition comprises natural, non-addictive, non-abusable nutrient precursors which are scientifically designed to restore the extensive deficiencies and imbalances with regard to kilocalories, vitamins, minerals, and proteins in the alcoholic. The nutritional care provided by this composition corrects many metabolic deficiencies associated with alcohol abuse. It is a balanced formula that promotes restoration of normal digestive and nutrient absorption mechanisms in the recovering alcoholic patient. In particular, this composition is designed to correct nutritional deficiencies and other imbalances for rapid repair of damaged tissues, including restoration of normal neuro-transmitting function of nerves in the recovering ^'alcoholic. In a particularly preferred composition in accordance with the invention, the above ingredients are used in roughly the following percentages (by weight); DL-phenylalanine, 50 - 80%; cysteine, 4 - 10%; L- glutamine, 4 - 10%; L-tyrosine, 4 - 10%; choline, 0.1 - 5%; minerals, 8 - 20%; and vitamins, 1.0 - 8%.

The specific combination of amino acids to be used in accordance with this embodiment of the invention is designed to aid alcoholic patients with related problems such as malnutrition. Malnutrition in alcoholics is chiefly caused by appetite suppression, with a resulting deficit of required nutrients, especially proteins and vitamins. Diminished capacity for intestinal absorption of nutrients eventually further complicates the alcoholic's capacity to utilize any nutrients. A state of chronic malnutrition results that becomes evident by its effects on the central nervous system. Nervous system disorders such as Wernicke-Korsakoff disease, often result in degenerative changes in the peripheral nerves and in the nerves of the cerebral cortex, as well as neuritis and muscle atrophy. Brain damage can also result in the most serious cases. It is established that alcohol acts on the acetylcholine receptors in neural fibers which produces a number of specific effects, and it acts nonspecifically to produce desensitization, a property it shares with general anesthetics.

The present composition and method focuses on providing the required precursor amino acids to aid these problems. In particular, the monoamine neurotransmitters that are synthesized in the brain, particularly serotonin, acetyl- choline, and the catecholamines, can be improved through the administration of the amino acids phenylalanine, tyrosine, and choline. Increased intake of these tissue precursors results in increased synthesis of neural tissue, and very often restores order to the malfunctioning nervous system of the alcoholic. Further, since carrier molecules transport six neutral amino acids to the brain, phenylalanine and tyrosine must compete with these amino acids for transport to the brain. It is therefore important that the concentration of the important neurotransmitter precursors, particularly phenylalanine and tyrosine, be augmented to more rapidly accomplish the repair of a diminished neuro-transmitter system. Tyrosine is the precursor for dihydroxyphenylalanine (dopa) , and its oxidation product 3,4-dioxyphenylalanine (dopa quinone) . The dopa compounds are members of a class of neuro¬ transmitters known as catecholamines. Dopamine, a member of this group, is found in the brain, and is associated with human motor functions. Tyrosine is also a precursor of epinephrine and norepinephrine which are formed in neural cells and which play an important role in regulating bloods pressure. Since dopa is an intermediate in the synthesis of these compounds, the close relationship between tyrosine and phenylalanine with the synthesis of neurotransmitters is apparent. n addition to the above-mentioned amino acids, the composition of the invention preferably includes choline, which can be utilized, e.g., in the form of choline bitartrate; glutamic acid or L-glutamine; and cysteine, a reactant in the synthesis of co-enzyme A which initiates and takes part in many metabolic reactions. Choline is an important restorative compound for alcohol-induced neural disorders and is effective in the restoration of cholinergic neural cells in the cerebral cortex which are particularly sensitive to toxins such as alcohol. Glutamic acid is the precursor for powerful neuro-transmitters found in the central nervous system, principally in the gray matter of the brain. Taken together with the appropriate vitamins and minerals, combinations of amino acids including DL-phenylalanine, L- tyrosine, cysteine, gluta ine, and choline form an effective composition for reducing the craving of alcohol and assisting in treatment to combat the addiction.

In the composition for treating alcohol addiction, in accordance with the invention, the preferred vitamin regimen includes effective quantities of vitamin B-l (thiamin) , vitamin B-2 (riboflavin) , vitamin B-3 (niacinamide) , vitamin B-6 (pyridoxine) , vitamin B-9 (folic acid) , vitamin B-12 (cobalamin) and vitamin E (alpha tocopherol) . In a pharmaceutical composition of the invention comprising the amino acids, vitamins and minerals in the range of percentages set forth above, it is preferred that the composition comprises the following specific vitamins in roughly the following weight percentages: vitamin B-l, 0.8 - 3.0%; vitamin B-2, 0.1 - 1.0%; vitamin B-3, 0.6 - 3.0%; vitamin B-6 0.1 - 1.0%; vitamin B-9, 0.01 - 1.0%, vitamin B-12, 0.001 -0.1%; and vitamin E, 0.01 - 3.0%. The substantial amount of B vitamins in the above composition is necessary because alcoholic patients are often seriously deficient in these vitamins. The water soluble B vitamins are generally concerned with maintenance of tissues in the digestive system, including the liver, skin and the nervous system. Very often, the decreased food intake associated with alcoholism results in serious avitaminosis which then evolves into impaired digestion and absorption of nutrients. These conditions are among those treated by the added B vitamins of the present composition. In cases of alcohol-induced colastasis, lipid metabolism is defective and absorption of the fat soluble vitamins is poor. In these conditions, vitamin E is in short supply and is required for cellular health. Thus, in general, all of the vitamins included in the composition of the present invention augment the amino acids discussed above and will be helpful in restoring in the health of an addicted patient.

In many cases of alcoholism, mineral deficiency due to primary and secondary malnutrition often results. The exclusion of many foods from the diet, and the secondary cause of inhibited absorption of nutrients constitute serious nutritional risks. Thus, lack of dietary nutrients, electrolyte imbalance, and chronic mineral deficiency often result in cardiac arrythmia, dermatitis, neurological disorders, and a host of other problems in the addicted patient. The composition of the present invention thus includes several important minerals which are often found deficient in alcohol-related malnutrition. In particular, minerals selected from the group consisting of calcium, chromium, magnesium, phosphorous, potassium and zinc should be employed in conjunction with the amino acid therapy composition of the present invention. The minerals should be employed in any physiologically accepted form, such as calcium gluconate to provide the calcium, magnesium oxide to provide magnesium, potassium and zinc gluconates to provide those minerals, and chromium which is generally provided from yeast complex. In the particularly preferred embodiment, the minerals used in conjunction with the vitamins and amino acids in the percentages described above will be roughly in the following percentages by weight: calcium, 2 - 6%; magnesium, 0.5 - 2.0%; phosphorus, 2 - 5%; potassium, 4 - 10%; zinc, 0.4 - 2%; and chromium, .0001 - 0.1%.

In accordance With the particularly preferred embodiment of the present invention, a pharmaceutical composition used in the treatment of alcohol addiction is preferably prepared in any physiologically acceptable form, such as a capsule, tablet or other mode suitable for oral administration, and preferably will have ingredients in the following ranges:

Ingredient Amount Per Capsule (Particularly preferred amounts in parenthesis)

DL-Phenylalanine 425 - 525 mg (475 mg)

Cysteine 25 - 75 mg (50 mg)

L-Glutamine 25 - 75 mg (50 mg)

L-Tyrosine 25 - 75 mg (45 mg)

Choline 5 - 25 mg (15 mg)

Calcium 5 - 25 mg (15 mg)

Magnesium 2 - 20 mg (10 mg)

Phosphorous 15 - 35 mg (25 mg)

Potassium 25 - 60 mg (45 mg)

Zinc 2 - 20 mg ( 8 mg)

Chromium 0.1 - 50 meg (5 meg)

Vitamin B-l 5 - 25 mg (13 mg)

Vitamin B-2 0.1 - 10 mg ( 2 mg)

Vitamin B-3 5 - 20 mg (12 mg) Vitamin B-6 0.5 - 8 mg ( 3 mg)

Vitamin B-9 0.05 - 5 mg (.5 mg)

Vitamin B-12 1 - 100 meg (50 meg)

Vitamin E 15 - 35 I.U. (25 I.U.)

In the preferred embodiment, the compositions to treat alcohol abuse are prepared into easy-to-swallow capsules containing ingredients in the above ranges. Such capsules are indicated for all recovering alcoholics that can swallow solid food. Each capsule promotes a positive balance of anabolic tissue activity that repairs damaged tissue and restores normal neurotransmission activity, and it is preferred that six of these capsules be administered daily. In the particularly preferred method of administration, two of these capsules are taken three times daily, preferably with water or fruit juice and between meals. Optimum timing is one hour before meals. The preferred method of administration provides an effective amount of the essential amino acids, minerals, and vitamins that can be used to supplement recovery of the alcoholic undergoing treatment for his or her addiction.

The dosages as indicated herein are those that are recommended for maximum performance. However, as will be clear to a skilled practitioner in this art, dosages can be increased or decreased as necessary for a particular patient. It is contemplated that consultation with a physician for each individual case will be undertaken before a regimen of treatment is initiated. The present composition and method can thus provide a safe, effective and inexpensive system of treatment to aid a recovering alcoholic who is undergoing a program to overcome his addiction.

In accordance with the second embodiment of the present invention, a pharmaceutical composition for reducing the craving for stimulants in humans or animals is provided which •comprises amino acids, particularly DL-phenylalanine, L- tyrosine, taurine and L-glutamine, along with suitable vitamins and minerals. These particular amino acids have been identified as those which can best supplement a patient with the chemical deficiencies normally associated with drug abuse. In addition to the beneficial effects of DL-phenylalanine and L-tyrosine in combination as discussed above, taurine, L- glutamine, and L-tyrosine together have been observed to help regulate high blood sugar levels, reduce cravings, break down elevated cholesterol levels and to help alleviate depression and excessive irritability in many stimulant abusers. As indicated above, abusers of stimulants such as cocaine very often have major deficiencies in neurotransmitters such as dopamine. The combination of the tyrosine and phenylalanine ingredients of the present composition is essential in patient recovery since dopamine is made in the body from these amino acids. In a particularly preferred embodiment, the composition to treat stimulant abuse in accordance with the present invention will comprise amino acids, vitamins and minerals in roughly the following percentages (by weight) : DL- phenylalanine, 30 - 50%; L-tyrosine, 15 - 30%; taurine, 3 - 10%; L-glutamine, 3 - 10%; vitamins, 10 - 30%; and minerals, 4 - 20%.

In addition to the amino acids described above, the composition used in the treatment of drug addiction is supplemented by vitamins. In the preferred embodiment, the vitamins that are used in this composition will include vitamins C, B-l, B-2, B-3, B-6, and B-9. In the particularly preferred embodiment, these vitamins are used along with the above amino acids in the ranges as discussed above in roughly the following percentages (by weight) : vitamin C, 5 - 20%; vitamin B-l, 0.1 - 5%; vitamin B-2, 0.1 - 5%; vitamin B-3, 0.1 - 5%; vitamin B-6, 0.01 - 2%; vitamin B-9, 0.0001 - 1%. As in the case of the compositions used to reduce the craving for alcohol described above, these vitamins are particularly useful in improving the condition of digestive tissues, liver, skin, and the nervous system.

It is also preferred that a specific regimen of minerals be provided in the composition of the invention useful in reducing the craving for stimulants. As indicated above, these minerals can be utilized in any physiologically acceptable form commonly used in mineral or vitamin supplements. It is particularly preferred that minerals including magnesium, potassium, zinc, calcium, and chromium be used in the composition of this embodiment of the present invention. When employed in a composition including the above-described amino acids and vitamins in the percentages as indicated above, it is preferred that minerals having roughly the following range of percentages be employed: magnesium, 1 - 7%; potassium, 1 - 7%; zinc, 0.1 - 4%; calcium, 0.05 - 3%; and chromium, 0.0001 - 0.1%. As indicated above, the added minerals are designed to overcome the deficiencies commonly observed in stimulant abusers.

In accordance with the second embodiment of the present invention, a pharmaceutical composition useful in reducing the craving for stimulants such as cocaine, amphetamines, or other drugs, is preferably prepared with the following ingredients and amounts: Ingredients Amount Per Capsule (Particularly preferred amounts in parenthesis)

DL-Phenylalanine 200 - 400 mg (300 mg)

L-Tyrosine 100 - 200 g (167 mg)

Taurine 25 - 75 mg (50 mg)

L-Glutamine 25 - 75 mg (50 mg)

Magnesium 15 - 35 mg (25 g)

Potassium 15 - 35 mg (25 mg)

Zinc 3 - 15 mg (10 mg)

Calcium 2 - 10 mg ( 5 mg)

Chromium 1 - 50 meg ( 5 meg)

Vitamin C 50 - 150 mg (100 mg)

Vitamin B-l 5 - 25 mg (15 mg)

Vitamin B-2 5 - 25 mg (15 mg)

Vitamin B-3 5 - 25 mg (15 mg)

Vitamin B-6 1 - 8 mg ( 4 mg)

Vitamin B-9 1 - 50 meg (8 meg)

The above composition is preferably prepared in the form of an easy-to-swallow capsule or other suitable pill or tablet. In the preferred method of administration, six capsules a day of the above composition are taken orally by the patient with water, juice or other suitable nonprotein or nondairy liquid. Again, as with the previous embodiment, the particularly preferred method will comprise taking two capsules three times daily, preferably one hour before meals. Although this dosage is recommended for most patients, it will be clear to one skilled in the art that greater or lesser amounts may be effective with particular patients, such as would be determined by the supervising physician.

The present invention thus provides a system which significantly reduces the craving for alcohol or stimulants while at the same time subsequently improving the general health of the patient as well. In test studies wherein the compositions of the present invention were provided to addicted individuals, significant numbers of patients have experienced a decrease in the craving for the particular substance the individual was addicted to. More significantly, most recovering patients increasingly felt better about themselves and reported increased energy over those in control groups not taking the supplement. The present composition and method thus will provide a safe, effective, and inexpensive way of supplementing the important work being carried out in treatment centers and counseling programs carrying on the fight against drug and alcohol abuse.

The following examples are presented as illustrative only of the present invention, and are not intended to limit the scope of the invention in any way:

EXAMPLE 1 - Composition for Reducing the Craving for Alcohol

An easy-to-swallow capsule was prepared in accordance with the present invention which contained the following ingredients:

Ingredient Amount Per Capsule

DL-phenylalanine 475 mg cysteine 50 mg glutamine 50 mg

L-tyrosine 45 mg choline bitartrate 15 mg vitamin B-l 13 mg vitamin B-2 2 mg vitamin B-3 12 mg vitamin B-6 3 mg vitamin B-9 0.5 mg vitamin B-12 50 meg vitamin E 25 I.U. calcium gluconate 15 mg chromium (yeast complex) 5 meg magnesium oxide 10 mg potassium gluconate 45 mg zinc gluconate 8 mg

Two of the above capsules were administered three times daily to the patients at a period approximately one hour before meals. The composition was found to reduce the craving for alcohol in a high percentage of cases.

EXAMPLE 2 - Composition for Reducing Craving for Stimulants

A composition in accordance with the present invention suitable for reducing the craving for stimulants in addicted individuals was prepared having the following ingredients and amounts:

potassium gluconate 25 mg zinc gluconate 10 mg calcium gluconate 5 mg chromium 5 meg

Two easy-to-swallow capsules with the above composition were administered to patients three times daily, approximately one hour before meals. In tests such as the one described below, patients were observed to undergo a reduction in the craving for the particular stimulant addicted to, and the overall health of the patient improved as well.

EXAMPLE 3 - Test Study Involving Administration of Composition to Reduce Craving for Stimulants

A study was performed to determine the effects of the method and composition of the present invention to reduce craving for stimulants which was carried out on patients in a clinical setting. Twenty subjects were in the treatment group, i.e., those receiving the composition of the invention in the dosage discussed above, and fourteen subjects were in the control group, i.e., those receiving no supplement. At the end of each of the first through the fourth week of the program the subjects responded to several questions. Most questions applied to the members of both groups, though some were only for the subjects in the treatment group. In certain cases, some of the subjects failed to answer a particular question, and as a result, the number answering a particular question is sometimes smaller than the total number of subjects in the group. Out of the subjects in the treatment group, compliance with the dosage recommendations was studied, and the great majority of the patients indicated that they had been following the suggested dosage of the capsules of the invention. By the fourth week all twenty members in the group receiving the composition of the invention indicated that they followed the recommended dosage.

At the end of each week, the subjects in the treatment group answered two questions about their cravings for stimulants. The first question inquired about the amount of craving, while the second asked if they felt that the system of the present invention was helping to reduce their craving for stimulants. On the first question, a high percentage constantly indicated that they felt no or low craving, and this percentage remained constant or increased each week. As to the second question, over 50% indicated that they definitely felt a reduction in craving, and this percentage rose sharply as the program went on. The weekly data in response to these questions are provided in Tables 1 and 2.

Table 1 - Level of Craving for Stimulants

WEEK

no craving 11 (58%) 14 (70%) 14 (70%) 16 (80%) decreased 75% 2 (11%) 2 (10%) 3 (15%) 3 (15%) decreased 50% 5 (26%) 3 (15%) 3 (15%) 1 ( 5%) strong craving 1 ( 5%) 1 ( 5%) 0 ( 0%) 0 ( 0%)

Table 2 - Any Reduction in Craving Observed?

__ 1 2 3 4

definitely 10 (52%) 12 (60%) 13 (72%) 19 (95%) a little 6 (32%) 8 (40%) 3 (16%) 1 ( 5%) not at all 3 (16%) 0 ( 0%) 2 (12%) 0 ( 0%)

Finally, the subjects in both the treatment group and the control group were asked at the end of each week to provide a self-assessment to see if they felt better about themselves than before they started the program. The results of these tests are provided in Table 3.

Table 3 - Self-Assessment: Does patient feel better about him/herself?

The results were all highly significant as determined by a chi-sguare analysis, and the analysis indicated that a significant difference existed in the self-assessments for the two groups. As can be observed, at the end of the four week period virtually every member of the treatment group felt better about themselves than they did before the start of this program.

The objective of the study was to assess the safety and efficiency of the compositions of the present invention in the treatment of adult clients with addictions to such stimulants as cocaine or methamphetamine. In such cases, cocaine and methamphetamine withdrawal normally produces intense anxiety and feelings of depression, and thus these traits were also monitored. The group treated by the composition of the present invention experienced a clear reduction in craving over the four weeks, and the testing results also indicated that they felt significantly better about themselves than the control group did throughout the study. In addition, each client tolerated the formulations well, and no abnormal reaction whatsoever was observed by the investigators. The product of the present invention was thus observed to be a safe and effective adjunct to addiction therapy, and was found to be useful in increasing the energy and well-being of a person in a stimulant recovery program.

EXAMPLE 4 - Test Study Involving

Administration of Composition to

Reduce Craving for Alcohol

A study was performed to determine the effects of the method and composition of the present invention to reduce craving for alcohol which was carried out on patients in a clinical setting. Twenty-one subjects were in the treatment group, and these individuals received the composition of the invention in the dosage discussed above. At the end of each of the first through the third week of the program the subjects responded to several questions. The subjects in the treatment group were also questioned with regard to compliance with the dosage recommendations, and practically all of the patients indicated that they had been following the suggested dosage of the capsules of the invention. By the third week, all twenty-one members in the group receiving the composition of the invention indicated that they followed the recommended dosage.

At the end of each week, the subjects in the treatment group answered two questions about their cravings for alcohol. The first question inquired about the amount of craving, while the second asked if they felt that the system of the present invention was helping to reduce their craving for alcohol. On the first question, a high percentage constantly indicated that they felt no or low craving, and this percentage remained constant or increased each week. As to the second question, over 50% indicated that they definitely felt a reduction in craving, and this percentage rose sharply as the program went on. The weekly data in response to these questions are provided in Tables 4 and 5.

Table 4 - Level of Craving for Alcohol

___ 1 2 3

no craving 18 (86%) 18 (86%) 21 (100%) decreased 75% 0 ( 0%) 3 (14%) 0 ( 0%) decreased 50% 0 ( 0%) 0 ( 0%) 0 ( 0%) strong craving 3 (14%) 0 ( 0%) 0 ( 0%)

Table 5 - Any Reduction in Craving for Alcohol Observed?

WEEK

3

definitely 12 (57%) 12 (57%) 18 (86%) a little 0 ( 0%) 6 (29%) 3 (14%) not at all 9 (43%) 3 (14%) 0 ( 0%)

The results all indicated that practically every patient experienced some benefits from this program. The objective of the study was to assess the safety and efficiency of the compositions of the present invention in the treatment of adult clients with alcohol addictions, and it was clearly shown that the individuals treated by the composition of the present invention experienced a reduction in craving for alcohol over the three week testing period. In addition, each client tolerated the formulations well, and no abnormal reaction whatsoever was observed by the investigators. the composition of the present invention was thus observed to be a safe and effective adjunct to addiction therapy, and was found to be useful in increasing the energy and well-being of a person in a alcohol recovery program, and in reducing that person's craving for alcohol.

Claims

WHAT IS CLAIMED IS:

1. A pharmaceutical composition for reducing the craving for alcohol in humans or animals comprising DL-phenylalanine, cysteine, L-glutamine, L-tyrosine, choline, vitamins and minerals.

2. A pharmaceutical composition according to claim 1, comprising about 50-80% by weight DL-phenylalanine, 4-10% cysteine, 4-10% gluta ine, 4-10% L-tyrosine, 0.1-5% choline, 1-8% vitamins and 8-20% minerals.

3. A pharmaceutical composition according to claim 1, wherein the minerals are selected from the group consisting of calcium, chromium, magnesium, phosphorous, potassium, zinc and combinations of the above.

4. A pharmaceutical composition according to claim 1, wherein the vitamins are selected from the group consisting of vitamins B-l, B-2, B-3, B-6, B-9, B-12, E, and combinations, of the above.

5. A pharmaceutical composition according to claim 2, wherein the minerals of the composition comprise about 4-10% by weight calcium, 2-5% phosphorous, 4-10% potassium, 0.5-2% magnesium, 0.4-2% zinc and 0.0001-0.1% chromium.

6. A pharmaceutical composition according to claim 2, wherein the vitamins comprise about 0.8-3.0% by weight vitamin B-l, 0.1-1% vitamin B-2, 0.6-3% vitamin B-3, 0.1-1% vitamin B-6, 0.1-1% vitamin B-9, 0.001-0.1% vitamin B-12, and 0.1- 3.0% Vitamin E.

7. A pharmaceutical compositior. according to claim 1 comprising the following ingredients in roughly the following amounts:

DL-phenylalanine 425 to 525 mg;

Cysteine 25 to 75 mg;

L-Glutamine 25 to 75 mg;

L-Tyrosine 25 to 75 mg;

Choline 5 to 25 mg;

Calcium 5 to 25 mg;

Magnesium 2 to 20 mg;

Phosphorous 15 to 35 mg;

Potassium 25 to 60 mg;

Zinc 2 to 20 mg;

Chromium 0.1 to 50 meg;

Vitamin B-l 5 to 25 mg;

Vitamin B-2 0.1 to 10 mg;

Vitamin B-3 5 to 20 mg;

Vitamin B-6 0.5 to 8 mg;

Vitamin B-9 0.05 to 5 mg;

Vitamin B-12 1 to 100 meg;

Vitamin E 15 to 35 I.U.

8. A method of reducing the craving for alcohol comprising administering to a human or animal patient the composition of claim 1 in an amount effective to reduce the craving for alcohol.

9. A method of reducing the craving for alcohol comprising administering to a human or animal patient six times a day the composition of claim 7.

10. A method according to claim 9 wherein the composition is administered to the patient in the form of two capsules taken three times daily.

11. A pharmaceutical composition for reducing the craving for stimulants in humans or animals comprising DL- phenylalanine, L-tyrosine, taurine, L-glutamine, vitamins and minerals.

12. A pharmaceutical composition according to claim 11 comprising about 30*50% DL-phenylalanine, 15-30% L-tyrosine, 3-10% taurine, 3-10% L-glutamine, 10-30% vitamins and 4-20% minerals.

13. A pharmaceutical composition according to claim 12, wherein the vitamins are selected from the group consisting of vitamins C, B-l, B-2, B-3, B-6, B-9 and combinations of the above.

14. A pharmaceutical composition according to claim 12, wherein the vitamins comprise about 5-20% by weight Vitamin C, 0.1-5% Vitamin B-l, 0.1-5% Vitamin B-2, 0.1-5% Vitamin B- 3, 0.01-2% Vitamin B-6, and 0.0001-1% Vitamin B-9.

15. A pharmaceutical composition according to claim 11, wherein the minerals are selected from the group consisting of magnesium, potassium, zinc, calcium, chromium and combinations of the above.

16. A pharmaceutical composition according to claim 12, wherein the minerals comprise about 1-7% by weight magnesium, 1-7% potassium, 0.1-4% zinc, 0.05-3% calcium and 0.0001-0.1% chromium.

17. A pharmaceutical composition according to claim 11, comprising the following ingredients in the following amounts:

DL- henylalanine 200 to 400 mg;

L-Tyrosine 100 to 200 mg;

Taurine 25 to 75 mg;

L-Glutamine 25 to 75 mg;

Magnesium 15 to 35 mg;

Potassium 15 to 35 mg;

Zinc 3 to 15 mg;

Calcium 2 to 10 mg;

Chromium 1 to 50 meg;

Vitamin C 50 to 150 mg;

Vitamin B-l 5 to 25 mg;

Vitamin B-2 5 to 25 mg;

Vitamin B-3 5 to 25 mg;

Vitamin B-6 1 to 8 mg;

Vitamin B-9 1 to 50 meg.

18. A method of reducing the craving for stimulants comprising administering to a human or animal patient the composition of claim 11 in an amount effective to reduce the craving for stimulants.

19. A method of reducing the craving for stimulants comprising administering to a human or animal patient six times a day the composition of claim 17.

20. A method according to claim 19 wherein the composition is administered to the patient in the form of two capsules taken three times per day.