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 - 29 . (canceled) 
   
   
       30 . A method for the treatment of alcohol abuse in a patient comprising the steps of:
 evaluating the patient;   administering a therapeutically effective amount of a composition comprising a selective chloride channel modulator in a pharmaceutically acceptable carrier to the patient;   monitoring the patient during treatment;   prescribing the patient a therapeutic compound in addition to the selective chloride channel modulator; and   prescribing the patient an outpatient regimen.   
   
   
       31 . The method of  claim 30  wherein the 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. 
   
   
       32 . The method of  claim 30  wherein the selective chloride channel modulator is flumazenil. 
   
   
       33 . The method of  claim 32  wherein the therapeutically effective amount of flumazenil is between about 1.0 and 3.0 mg/day. 
   
   
       34 . The method of  claim 32  wherein the therapeutically effective amount of flumazenil is between about 1.5 and 2.5 mg/day. 
   
   
       35 . The method of  claim 30  wherein the therapeutic compound includes at least one of the following: fortified vitamin B complex, hydroxyzine, or gabapentin. 
   
   
       36 . The method of  claim 30  wherein the outpatient regimen includes at least one of diet, exercise, and cognitive therapy. 
   
   
       37 . The method of  claim 30  wherein the selective chloride channel modulator is a partial allosteric modulator at GABA A  receptor sites. 
   
   
       38 . The method of  claim 37  wherein the partial allosteric modulator acts with high potency but low efficacy at the GABA A  receptor sites. 
   
   
       39 . The method of  claim 37  wherein the partial allosteric modulator acts to reset the GABA A  receptor receptivity and increase chloride channel ion flow. 
   
   
       40 . The method of  claim 30  wherein the selective chloride channel modulator acts to reset changes in GABA A  subunits. 
   
   
       41 . The method of  claim 30  wherein the selective chloride channel modulator is a partial agonist of the GABA A  receptor. 
   
   
       42 . The method of  claim 30  wherein the selective chloride channel modulator is at least one of a imidazobenzodiazepine or a derivative of ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo- 4 H-imidazo-[1,5-a][1,4] benzodiazepine-3-carboxylate. 
   
   
       43 . A method for treating alcohol abuse in a patient comprising the steps of:
 evaluating the patient;   administering a therapeutically effective amount of a composition comprising flumazenil in a pharmaceutically acceptable carrier to the patient wherein the therapeutically effective amount of flumazenil is less than 3 mg/day and is delivered in individual doses of 0.4 mg or less over a period of 20 minutes or less;   monitoring the patient during treatment;   prescribing the patient a therapeutic compound in addition to the flumazenil; and   prescribing the patient an outpatient regimen.