Pharmaceutical preparation for the treatment of the symptoms of addiction and method of diagnosing same

Abstract

A therapeutic agent for the treatment of the symptoms of addiction and the method for preparing the therapeutic agent is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using of a biomarker, the presence of chymotrypsin in the gastrointestinal tract to determine the presence of symptoms of addiction, and the likelihood of relapsing into addiction is disclosed.

Claims

1. A method of diagnosing a subject as having a likelihood of drug addiction or an alcohol addiction or a likelihood of relapse into a drug addiction or an alcohol addiction in a subject, the method comprising: (a) analyzing a stool sample obtained from the subject with enzyme photospectrometry to determine the presence or absence of fecal chymotrypsin in the stool sample; (b) detecting a level of fecal chymotrypsin in the stool sample and comparing the level of fecal chymotrypsin in the stool sample to a normal level of fecal chymotrypsin, wherein the normal level of fecal chymotrypsin is greater than 8.4 U/gram; (c) diagnosing the subject as having the likelihood of drug addiction or the alcohol addiction or the likelihood of relapse into the drug addiction or the alcohol addiction when the fecal chymotrypsin is detected in the stool sample and when the level of fecal chymotrypsin is below the normal level of fecal chymotrypsin; and (d) administering a pharmaceutical composition comprising one or more digestive enzymes to the subject when the level of fecal chymotrypsin detected is below the normal level of fecal chymotrypsin.

2. The method of claim 1, wherein the drug addiction or the alcohol addiction comprises the drug addiction.

3. The method of claim 2, wherein the drug addiction comprises an addiction to cocaine, a pain reliever, tobacco, a sedative, or marijuana.

4. The method of claim 1, wherein the drug addiction or the alcohol addiction comprises the alcohol addiction.

5. A method of verifying a diagnosis of a subject as having a drug addiction or an alcohol addiction, or a relapse into a drug addiction or an alcohol addiction, in a subject, the method comprising: (a) analyzing a stool sample obtained from the subject with enzyme photospectrometry to determine the presence or absence of fecal chymotrypsin in the stool sample; (b) detecting a level of fecal chymotrypsin in the stool sample and comparing the level of fecal chymotrypsin in the stool sample to a normal level of fecal chymotrypsin, wherein the normal level of fecal chymotrypsin is greater than 8.4 U/gram; (c) verifying the diagnosis of the subject as having the drug addiction or the alcohol addiction or the relapse into the drug addiction or the alcohol addiction when the fecal chymotrypsin is detected in the stool sample and when the level of fecal chymotrypsin is below the normal level of fecal chymotrypsin; and (d) administering a pharmaceutical composition comprising one or more digestive enzymes to the subject when the level of fecal chymotrypsin detected is below the normal level of fecal chymotrypsin.

6. The method of claim 5, wherein the drug addiction or the alcohol addiction comprises the drug addiction.

7. The method of claim 6, wherein the drug addiction comprises an addiction to cocaine, a pain reliever, tobacco, a sedative, or marijuana.

8. The method of claim 5, wherein the drug addiction or the alcohol addiction comprises the alcohol addiction.

Description

DETAILED DESCRIPTION

(1) The individual who is diagnosed as alcoholic or as substance abuse addicted is administered a fecal chymotrypsin test where the level of the enzyme chymotrypsin is measured. The individual is then given an effective amount of pancreatic/digestive enzymes if the fecal chymotrypsin level is below 8.4 U/mg. This level is considered abnormal when compared to an individual without alcoholism or substance abuse addiction, or who is not at risk for such an addiction, or having been addicted at any time in the past, or who has other protein digestion problems.

(2) The fecal chymotrypsin levels may be measured in someone at risk for becoming an alcoholic or substance abuse addicted or who has had a history of alcoholism or substance abuse and who may again become an alcoholic or substance abuse addicted. The steps involve the following: taking a stool sample from the individual to be diagnosed, measuring the level of fecal chymotrypsin in the stool sample, and comparing that level to an individual who does not have alcoholism, a substance abuse problem or other protein digestion problem. When the level is low, less than 8.4 U/mg, an effective amount of pancreatic enzymes is administered to the individual.

(3) The invention may be used as the or one of the components of an alcohol treatment or substance abuse treatment program for an active alcoholic or substance abuse addict. The invention may also be utilized to keep someone at risk for becoming an alcoholic or substance abuser or it may be used to prevent someone from relapse into addiction. The pancreatic/digestive enzymes may be given to prevent addiction, such as alcoholism or substance abuse, to help someone who is presently an addict such as an alcoholic or drug addict, or to someone who is at risk of relapse. The enzymes may be administered as a result of a lowered fecal chymotrypsin level.

(4) Pancreatic/digestive enzymes may be administered to those who are presently battling active addiction such as alcoholism or drug abuse. They may be given to those who are not actively addicted, but who have been addicted at another time and who are at risk for becoming an addict, such as an alcoholic, drug addict or other substance abuse addict. They may also be utilized for those who are deemed at risk for addiction, such as alcoholism, due to family history or other historical events, such as severe stress or other factors placing the individual at risk.

(5) In one embodiment, a stable preparation of digestive/pancreatic enzymes is formed into a dosage formulation containing a therapeutically effective amount of a protease, an amylase, and/or a lipase. The formulation may include additional enzymes, such as pancreatin, chymotrypsin, trypsin, papain and/or papaya. Other combinations of digestive enzymes may also be used. These enzymes can be in the form of animal or plant derivatives, natural or synthetic.

(6) The following outlines a formulary for digestive/pancreatic enzymes for treating the symptoms of addiction: Amylase 10,000-60,000 U.S.P Protease 10,000-70,000 U.S.P Lipase 4,000-30,000 U.S.P Pancreatin 2,000-6,000 U.S.P Chymotrypsin 2-5 mg Trypsin 60-100 mg Papain 3,000-10,000 U.S.P. units/mg Papaya 30-60 mg.

(7) The dosage formulation may be administered by an oral preparation including, but not limited to, an encapsulated tablet, mini-tabs, microcapsule, mini-capsule, time released capsule, sprinkle or other methodology. In one embodiment, the oral preparation is encapsulated using PROSOLV® technology. Alternatively, the oral preparation may be encapsulated using enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and/or a combination of these methods.

(8) Fecal chymotrypsin is a sensitive, specific measure of proteolytic activity. Normal levels of chymotrypsin are considered be greater than 8.4 U/gram. Decreased values (less than 8.4 U/gram) suggest diminished pancreatic output (pancreatic insufficiency), hypoacidity of the stomach or cystic fibrosis. Elevated chymotrypsin values suggest rapid transit time, or less likely, a large output of chymotrypsin from the pancreas.

(9) For the fecal chymotrypsin test, a stool sample is collected from each of the subjects. Each stool sample is analyzed using an enzymatic photo spectrometry analysis to determine the level of fecal chymotrypsin in the stool. Alternatively, other methods, such as the colorimetric method, use of substrates, use of assays, and/or any other suitable method may be used to measure the fecal chymotrypsin levels. The levels of fecal chymotrypsin in the samples of the individuals to be diagnosed are compared to the levels of fecal chymotrypsin in an individual who does not have alcoholism, a substance abuse problem or other protein digestion problem to determine if the individual being diagnosed would benefit from the administration of digestive enzymes.

(10) The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.