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

a selective chloride channel and modulator technology, applied in the direction of biocide, drug composition, peptide/protein ingredients, etc., can solve the problems of increasing the compulsion to take more drugs, depressed motivation and mood, and depressed mood, so as to reduce cravings and withdrawal symptoms, and control cravings

a selective chloride channel and modulator technology, applied in the direction of biocide, drug composition, peptide/protein ingredients, etc., can solve the problems of increasing the compulsion to take more drugs, depressed motivation and mood, and depressed mood, so as to reduce cravings and withdrawal symptoms, and control cravings

US20050192271A1Inactive Publication Date: 2005-09-01HIGHBRIDGE INT LLC AS AGENT HIGHBRIDGE CAPITAL MANAGEMENT

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

Examples

Experimental program
Comparison scheme
Effect test

example 1

Treatment of Patients With Flumazenil in Multiple Dosages at Predetermined Time Periods

1.1 Experimental Protocol

[0252] 64 alcoholics (51 males and 13 females) voluntarily entered a treatment program to discontinue the use of alcohol. The patients were provided the appropriate information and the corresponding informed consent form was obtained from them. The patients were warned not to drink alcohol the morning on which the treatment was to be carried out to enable better evaluation of the withdrawal symptoms. Table 14 summarizes the characteristics of the patients treated associated with alcohol use.

TABLE 14Characteristics of Patients Associated withAlcohol Use (note: 85% consumed alcohol daily and 39.1%consumed benzodiazepines daily).STANDARDMINI-MAXI-CHARACTERISTICSMEANDEVIATIONMUMMUMAGE (YEARS)42.710.22075AGE AT BEGINNING24.610.2671OF DAILY ALCOHOLUSE (YEARS)DAILY UNITS OF24.915.4473ALCOHOL INTAKEGAMMA-GLUTAMYL159.1227.2121.230TRANSPEPTIDASE(GGT)CORPUSCULAR97.86.472111VOLUM...

example 2

Improved Methodology for the Administration of Flumazenil to Treat Alcohol Dependency

[0276] Before starting the protocol, the patients underwent a complete medical and psychological examination. The monitoring of the patients included a complete blood count, a biochemical profile [creatinine, glucose, blood urea nitrogen (BUN), cholesterol (HDL and LDL), triglycerides, alkaline phosphatase, LDH (lactic dehydrogenase) and total proteins], hepatic function tests [GOT, GPT, GGT, bilirubin), electrocardiogram and, if need be, pregnancy test and x-ray examination. The exclusion criteria applied included acute or uncompensated illnesses, as well as the taking of any drug contraindicated with flumazenil. No patient was excluded after the pre-admission interview and the tests performed.

[0277] In addition, patients diagnosed with a psychotic disorder received anti-psychotic medication. Patients diagnosed with arterial hypertension are prescribed the appropriate medication or instructed to ...

example 3

Improved Methodology for the Administration of Flumazenil to Treat Alcohol Dependency

[0281] In accordance with this embodiment of the present invention, as related to such example, a protocol for the treatment of alcohol cravings is described in the table below:

Day 3 -TimeAdmission DayDay 2DischargePre-ProcedureAtaraxAtaraxFortified(AM)(sedative) -(sedative) -Vitamin B50 mg (1-2 hour50 mg (1-2 hourcomplex.pre-procedure).pre-procedure).May repeat withMay repeat withProtein25 mg for25 mg forDrink.anxiety ifanxiety ifneeded.needed.FortifiedFortifiedVitamin BVitamin Bcomplex.complex.Protein Drink.Protein Drink.ProcedureFlumazenil 2 mgFlumazenil 2 mgper dayper dayPost-ProcedureAtarax 50 mg. atAtarax 50 mg. at(PM)bedtime maybedtime mayrepeat with 25 mg.repeat with 25 mg.as neededas neededfor sleep.for sleep.

[0282] At discharge, the following may be administered: disulfiram 250 mg., daily for six months; glutamic acid, 500 mg., once daily for one day, twice daily for one day, then three...

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Abstract

The invention relates to methods of and treatments for using pharmaceutical compositions from a class of compounds that directly or indirectly selectively modulates GABAA 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.

Description

CROSS REFERENCE [0001] The present invention is a continuation in part of U.S. patent application Ser. No. 10 / 621,229, entitled “Use of flumazenil in the production of a drug for the treatment of alcohol dependency”, filed on Jul. 15, 2003.FIELD OF THE INVENTION [0002] The invention relates to methods of, and methodologies for, using pharmaceutical compositions from a class of compounds that directly or indirectly selectively modulates GABAA chloride channel activity to treat alcohol and / or psychostimulant substance abuse, including, but not limited to, the various physical and psychological states that manifest an individual's impaired control over substance use, addiction, continued substance use despite harm, compulsive substance use, cravings, psychological dependence, physical dependence, tolerance, a maladaptive pattern of substance use, preoccupation with substance use, and / or the prevalence of withdrawal symptoms upon cessation of use. The present invention also relates to m...

Claims

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Application Information

Patent Timeline
01 Sep 2005
Publication
US20050192271A1
IPC
A61K31/195; A61K31/551
CPC
A61K31/137; A61K31/195; A61K31/551; A61K31/5517; A61K45/06; A61K2300/00; A61P25/30; A61P25/32
Inventors
LEGARDA IBANEZ, JUAN JOSE