Patent Publication Number: US-4647460-A

Title: Composition and method for narcotics withdrawal

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates to narcotics addiction, and particularly to treatments for easing the physical and emotional symptoms attendant upon narcotics withdrawal. 
     Narcotics addiction is the unfortunate result not only of drug abuse but also of a variety of human hardship situations, severely reducing the quality of life of those addicted as well as their ability to contribute to society. One of the best known treatments is the use of methadone hydrochloride as a substitute for the narcotic during withdrawal. Unfortunately, the physical discomfort and emotional unrest normally associated with the drug originally giving rise to the addiction has been found to recur upon discontinuing the administration of methadone. In addition, it has been found that the volume of methadone required to overcome the withdrawal symptoms arising from the original drug gradually increases as a patient continues to use the methadone, as does the tendency to become addicted to methadone itself. 
     SUMMARY OF THE INVENTION 
     It has now been discovered that a unique combination of herbal ingredients, none of which are addictive, has the capability of reducing and ultimately eliminating most if not all of the unpleasant withdrawal symptoms when administered to a narcotics addict upon cessation of narcotics intake. The effect is seen in a wide range of symptoms, ranging from physical manifestations and discomfort to emotional unrest, and including the various bodily symptoms such as the circulatory, nervous and digestive systems. 
     DETAILED DESCRIPTION OF THE INVENTION 
     The composition of the present invention contains a combination of active ingredients, all naturally derived and primarily herbal in origin. The ingredients are as follows: 
     (a) Ginseng radix 
     (b) Amanae bulbus 
     (c) Puchrestrae radix 
     (d) Euphorbiae pekinensis 
     (e) Lathyridis semen 
     (f) Auicular margark feral 
     (g) Manis squama 
     (h) Zizyphi spinosi semen 
     (i) Angelicae gigantis radix 
     (j) Cnidii rhizoma 
     (k) Rehmaniae radix 
     (l) Paeoniae radix 
     The amount of each ingredient as a proportion of the whole may vary, although certain proportions are preferred--namely, the Ginseng radix preferably comprises about 20% to about 30% by weight; the Amanae bulbus, Puchrestrae radix, Euphorbiae pekinensis, and Lathyridis semen each individually comprise about 10% to about 20% by weight; the Zizyphi spinosi semen, Angelicae gigantis radix, the Cnidii rhizoma, and Rehmaniae radix and the Paeoniae radix each individually comprise about 3% to about 10% by weight; and the Auicular margark feral and the Manis squama each comprise from about 0.05% to about 1.0% by weight, all weight percents based on total active ingredients. In fact, a composition having the following amounts, based on a 250 mg total, has been found to be particularly effective: 
     Ginseng radix: 60 mg 
     Amanae bulbus: 45 mg 
     Puchrestrae radix: 25 mg 
     Euphorbiae Pekinensis: 32.5 mg 
     Lathyridis semen: 25 mg 
     Auicular margark feral: 0.175 mg 
     Manis squama: 2.325 mg 
     Zizyphi spinosi semen: 18.75 mg 
     Angelicae gigantis radix: 9.375 mg 
     Cnidii rhizoma: 9.375 mg 
     Rehmaniae radix: 11.25 mg 
     Paeoniae radix: 11.25 mg 
     While the composition may be administered in any convenient form, it is preferably combined prior to consumption as an intimate mixture, by grinding the components together to a powdered consistency, or liquifying them as a suspension or solution. The composition may then be consumed in liquid or solid form. For purposes of treatment, the composition is taken internally, preferably orally. 
     The composition may be rendered in a form which provides slow release to the digestive system. Capsules and encapsulated embodiments are particularly convenient in this regard. 
     The dosage may vary depending on the level of narcotic intake prior to withdrawal, and hence the severity of the withdrawal symptoms, as well as the size and physical condition of the patient. In most cases, a quantity ranging from about 0.5 to about 20 grams per day, preferably from about 1 to about 10 grams per day, in each case based upon the aggregated active ingredients. Administration of the composition is preferably achieved by dividing the daily dosage into small portions taken at equally spaced intervals throughout the day. About 2 to about 10 portions per day, preferably about 4 to about 6, will generally provide the best results. 
     The composition may be combined with or taken in conjunction with other treatments or medicaments, such as tranquilizers, sleep-promoting agents and the like. The treatment is applicable to narcotic or opiate addiction in general, and particularly to heroin or morphine addiction. 
     The active ingredients are known naturally derived species, primarily herbal, readily obtainable from natural sources by conventional methods. 
     The following examples are offered for illustrative purposes only, and are intended neither to limit nor define the invention in any manner. 
    
    
     EXAMPLES 
     Twenty male patients under treatment for heroin addiction in the Psychoneurologic Department of PRAMONGKUT KLAO Army Hospital in Bangkok, Thailand were tested. The age distribution of the patients was as follows: 
     
                       TABLE 1                                                     
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Age Distribution of Patients                                              
Age Range (years)                                                         
                Number of Patients                                        
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Below 20        1                                                         
20-25           13                                                        
26-30           3                                                         
31-35           1                                                         
36-40           1                                                         
41-45           1                                                         
Total:          20                                                        
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     The distribution among the patients of the duration of heroin abuse prior to treatment was as follows: 
     
                       TABLE 2                                                     
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Abuse Duration Distribution                                               
Duration      Number of Patients                                          
______________________________________                                    
6 months-1 year                                                           
              4                                                           
2-5 years     11                                                          
6 years or more                                                           
              5                                                           
Total:        20                                                          
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     The rate of heroin consumption per patient prior to treatment was distributed as follows: 
     
                       TABLE 3                                                     
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Consumption Rate Distribution                                             
Quantity per Day                                                          
                Number of Patients                                        
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Approximately 30 mg                                                       
                8                                                         
40-100 mg       10                                                        
150-200 mg      1                                                         
Above 200 mg    1                                                         
Total:          20                                                        
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     Capsules containing the following active ingredients were used for treatment: 
     
                       TABLE 4                                                     
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Treatment Composition                                                     
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Ginseng radix      60         mg                                          
Amanae bulbus      45         mg                                          
Puchrestrae radix  25         mg                                          
Euphorbiae pekinensis                                                     
                   32.5       mg                                          
Lathyridis semen   25         mg                                          
Auicular margark feral                                                    
                   0.175      mg                                          
Manis squama       2.325      mg                                          
Zizyphi spinosi semen                                                     
                   18.750     mg                                          
Angelicae gigantis radix                                                  
                   9.375      mg                                          
Cnidii rhizoma     9.375      mg                                          
Rehmaniae radix    11.25      mg                                          
Paeoniae radix     11.25      mg                                          
Total:             250        mg                                          
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     The patients were each administered four capsules four times per day over a fourteen-day period. The patients were examined by observation on the seventh and fourteenth days for a series of symptoms, with the results listed below in Tables 5 and 6. 
     
                       TABLE 5                                                     
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Incidence of Withdrawal Symptoms                                          
After Seven Days                                                          
                      Number of  Number of                                
                      Patients   Patients                                 
          Number of   Experiencing                                        
                                 Experiencing                             
          Patients Not                                                    
                      Symptom to Symptom to                               
          Experiencing                                                    
                      Moderate   Extreme                                  
Symptom   Symptom     Degree     Degree                                   
______________________________________                                    
Lacrimation                                                               
          11          9          0                                        
Rhinorrhea                                                                
          19          1          0                                        
Yawning   12          8          0                                        
Goose flesh                                                               
          13          7          0                                        
Perspiration                                                              
          12          8          0                                        
Restlessness                                                              
          14          6          0                                        
Chills    17          3          0                                        
Abdominal pain                                                            
          17          3          0                                        
Diarrhea  18          2          0                                        
Vomiting  19          1          0                                        
Body weakness                                                             
           9          11         0                                        
Anorexia  14          6          0                                        
Sleep     17          3          0                                        
disturbances                                                              
Anxiety   13          7          0                                        
Leg muscle                                                                
          14          6          0                                        
spasms                                                                    
Joint pains                                                               
          12          8          0                                        
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                       TABLE 6                                                     
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Incidence of Withdrawal Symptoms                                          
After Fourteen Days                                                       
                      Number of  Number of                                
                      Patients   Patients                                 
          Number of   Experiencing                                        
                                 Experiencing                             
          Patients Not                                                    
                      Symptom to Symptom to                               
          Experiencing                                                    
                      Moderate   Extreme                                  
Symptom   Symptom     Degree     Degree                                   
______________________________________                                    
Lacrimation                                                               
          20          0          0                                        
Rhinorrhea                                                                
          20          0          0                                        
Yawning   16          4          0                                        
Goose flesh                                                               
          20          0          0                                        
Perspiration                                                              
          17          3          0                                        
Restlessness                                                              
          18          2          0                                        
Chills    20          0          0                                        
Abdominal pain                                                            
          18          2          0                                        
Diarrhea  20          0          0                                        
Vomiting  19          1          0                                        
Body weakness                                                             
          13          7          0                                        
Anorexia  13          7          0                                        
Sleep     20          0          0                                        
disturbances                                                              
Anxiety   14          6          0                                        
Leg muscle                                                                
          14          6          0                                        
spasms                                                                    
Joint pains                                                               
          17          3          0                                        
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