IP Library Patent Application 11111435
Patent Application
App. No. 11/111,435

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

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Patent No.
US None
App. No.
11/111,435
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.

Claims (50)

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.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Jul 29, 2022
From: GOLDMAN SACHS SPECIALTY LENDING GROUP, L.P., AS COLLATERAL AGENT
To: ONTRAK, INC. (FORMERLY KNOWN AS CATASYS, INC.)
Reel/Frame 060672/0554 →
SECURITY INTEREST Recorded Feb 10, 2020
From: HYTHIAM, INC (N/K/A CATASYS, INC.)
To: GOLDMAN SACHS SPECIALTY LENDING GROUP, L.P.
Reel/Frame 051767/0204 →
RELEASE OF SECURITY INTEREST Recorded Oct 24, 2019
From: HIGHBRIDGE MSF INTERNATIONAL LTD F/K/A HIGHBRIDGE INTERNATIONAL LLC
To: CATASYS, INC. F/K/A HYTHIAM, INC.
Reel/Frame 050817/0175 →
CORRECTIVE ASSIGNMENT TO CORRECT THE NATURE OF THE CONVEYANCE OF THE ASSIGNMENT PREVIOUSLY RECORDED ON REEL 018824 FRAME 0619. ASSIGNOR(S) HEREBY CONFIRMS THE NATURE OF THE CONVEYANCE IS THE GRANTING OF A SECURITY INTEREST RATHER THAN THE TRANSFER OF OWNERSHIP. Recorded Nov 6, 2007
From: HYTHIAM, INC.
To: HIGHBRIDGE INTERNATIONAL LLC, AS AGENT C/O HIGHBRIDGE CAPITAL MANAGEMENT, LLC
Reel/Frame 020075/0814 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2007
From: HYTHIAM, INC.
To: HIGHBRIDGE INTERNATIONAL LLC, AS AGENT C/O HIGHBRIDGE CAPITAL MANAGEMENT, LLC
Reel/Frame 018824/0619 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2005
From: IBANEZ, JUAN JOSE LEGARDA
To: HYTHIAM, INC.
Reel/Frame 016499/0175 →