Use of selective chloride channel modulators to treat alcohol and/or stimulant substance abuse

Abstract

The invention relates to methods of and treatments for using pharmaceutical compositions from a class of compounds that directly or indirectly selectively modulates GABA A chloride channel activity to treat alcohol and/or stimulant substance abuse. The present invention also relates to methods of, and protocols for, relieving symptoms associated with alcohol and/or stimulant substance abuse in a comprehensive treatment plan. More specifically, the present invention relates to the use of a selective chloride channel modulator, such as flumazenil, to treat alcohol and/or psychostimulant dependency, the withdrawal symptoms associated therewith, and the cravings associated therewith.

1 . A method for the treatment of alcohol abuse comprising the steps of: 
 evaluating a patient;    administering a therapeutically effective amount of a selective chloride channel modulator;    monitoring said patient during treatment;    prescribing said patient a therapeutic compound in addition to said selective chloride channel modulator; and    prescribing said patient an outpatient regimen.    
     
     
         2 . The method of  claim 1  wherein said patient evaluation step comprises at least one of the following: a complete physical examination, a complete psychological examination, a CIWA assessment, and a determination of required medications.  
     
     
         3 . The method of  claim 1  wherein said selective chloride channel modulator is flumazenil.  
     
     
         4 . The method of  claim 3  wherein said therapeutically effective amount of flumazenil is between about 1.0 and 3.0 mg/day.  
     
     
         5 . The method of  claim 3  wherein said therapeutically effective amount of flumazenil is between about 1.5 and 2.5 mg/day.  
     
     
         6 . The method of  claim 1  wherein said therapeutic compound includes at least one of the following: fortified vitamin b, hydroxyzine, or gabapentin.  
     
     
         7 . The method of  claim 1  wherein said outpatient regimen includes at least one of diet, exercise, and cognitive therapy.  
     
     
         8 . The method of  claim 1  wherein selective chloride channel modulator is a partial allosteric modulator.  
     
     
         9 . The method of  claim 8  wherein the partial allosteric modulator acts with high potency but low efficacy at said GABA A  receptor sites.  
     
     
         10 . The method of  claim 8  wherein the partial allosteric modulator acts to reset said GABA A  receptor receptivity and increase chloride channel ion flow.  
     
     
         11 . The method of  claim 1  wherein the selective chloride channel modulator acts to reset changes in GABA A  subunits.  
     
     
         12 . The method of  claim 1  wherein the selective chloride channel modulator is a partial agonist of the GABA A  receptor.  
     
     
         13 . The method of  claim 1  wherein the selective chloride channel modulator is at least one of a imidazobenzodiazepine or derivative of ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo-[1,5-a][1,4] benzodiazepine-3-carboxylate.  
     
     
         14 . A method for the treatment of stimulant abuse comprising the steps of: 
 evaluating a patient via a pre-treatment regimen;    administering a therapeutically effective amount of a selective chloride channel modulator;    monitoring said patient during treatment;    prescribing said patient a therapeutic compound in addition to said selective chloride channel modulator; and    prescribing said patient an outpatient regimen.    
     
     
         15 . The method of  claim 14  wherein said pre-treatment regimen includes at least one of the following: a complete physical examination, a complete psychological examination, a CIWA assessment, and a determination of required medications.  
     
     
         16 . The method of  claim 14  wherein said selective chloride channel modulator is flumazenil.  
     
     
         17 . The method of  claim 14  wherein said therapeutic compound includes at least one of the following: fortified vitamin b, hydroxyzine, gabapentin, or a protein supplement drink.  
     
     
         18 . The method of  claim 14  wherein said outpatient regimen includes at least one of diet, exercise, and cognitive therapy.  
     
     
         19 . The method of  claim 14  wherein said outpatient regimen includes the providing of pharmaceutical compositions.  
     
     
         20 . The method of  claim 19  wherein said pharmaceutical compositions include at least one of the following: 
 hydroxyzine, glutamine, fortified vitamin B 100 complex, amino acid supplements, or gabapentin.    
     
     
         21 . The method of  claim 14  wherein said steps of administering a therapeutically effective amount of a selective chloride channel modulator, monitoring said patient during treatment, and prescribing said patient a therapeutic compound in addition to said selective chloride channel modulator are repeated after three weeks of initial treatment.  
     
     
         22 . The method of  claim 14  wherein selective chloride channel modulator is a partial allosteric modulator.  
     
     
         23 . The method of  claim 22  wherein the partial allosteric modulator acts with high potency but low efficacy at said GABA A  receptor sites.  
     
     
         24 . The method of  claim 22  wherein the partial allosteric modulator acts to reset said GABA A  receptor receptivity and increase chloride channel ion flow.  
     
     
         25 . The method of  claim 14  wherein the selective chloride channel modulator acts to reset changes in GABA A  subunits.  
     
     
         26 . The method of  claim 14  wherein the selective chloride channel modulator is a partial agonist of the GABA A  receptor.  
     
     
         27 . The method of  claim 14  wherein the selective chloride channel modulator is at least one of a imidazobenzodiazepine or derivative of ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo-[1,5-a][1,4] benzodiazepine-3-carboxylate.  
     
     
         28 . A method for treating alcohol abuse comprising the steps of: 
 evaluating a patient;    administering a therapeutically effective amount of flumazenil wherein said therapeutically effective amount is less than 3 mg/day and delivered in individual doses no greater than 0.4 mg over a period of no greater than 20 minutes;    monitoring said patient during treatment;    prescribing said patient a therapeutic compound in addition to said selective chloride channel modulator; and    prescribing said patient an outpatient regimen.    
     
     
         29 . A method for the treatment of stimulant abuse comprising the steps of: 
 evaluating a patient via a pre-treatment regimen;    administering a therapeutically effective amount of flumazenil wherein said therapeutically effective amount is less than 3 mg/day and delivered in individual doses no greater than 0.4 mg over a period of no greater than 20 minutes;    monitoring said patient during treatment;    prescribing said patient a therapeutic compound in addition to said selective chloride channel modulator; and    prescribing said patient an outpatient regimen.