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(12) Patent Application Publication (10) Pub. No.: US 2002/0103109 A1 Glick Et Al US 2002O103109A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2002/0103109 A1 Glick et al. (43) Pub. Date: Aug. 1, 2002 (54) METHODS AND COMPOSITIONS FOR (52) U.S. Cl. .................................................................. 514/1 TREATING ADDICTION DISORDERS (57) ABSTRACT (76) Inventors: Stanley D. Glick, Delmar, NY (US); A method for treating an addiction disorder (Such as an Isabelle M. Maisonneuve, Delmar, NY addiction to or dependency on Stimulants, nicotine, mor (US) phine, heroin, other opiates, amphetamines, cocaine, and/or alcohol) in a patient is disclosed. The method includes Correspondence Address: administering to the patient a first CfB nicotinic receptor Braman & Rogalskyj, LLP antagonist and administering to the patient a second O?3. P.O. Box 352 nicotinic receptor antagonist. The Second CB nicotinic Canandaigua, NY 14424-0352 (US) receptor antagonist is different than the first C.B. nicotinic receptor antagonist, and the first C.B. nicotinic receptor (21) Appl. No.: 10/051,770 antagonist and the Second CB nicotinic receptor antagonist are administered simultaneously or non-simultaneously. (22) Filed: Jan. 18, 2002 Compositions which include a first C.B. nicotinic receptor Related U.S. Application Data antagonist and a Second O?3 nicotinic receptor antagonist are also described. Examples of Suitable C.B. nicotinic (60) Provisional application No. 60/264,742, filed on Jan. receptor antagonists for use in the present invention's meth 29, 2001. ods and compositions include mecamylamine, 18-methoxy coronaridine, bupropion, dextromethorphan, dextrorphan, Publication Classification and phamaceutically acceptable Salts and Solvates thereof. A method of evaluating a compound for its effectiveness in (51) Int. Cl. ............................................... A61K 31/00 treating addiction disorderS is also described. Patent Application Publication Aug. 1, 2002 Sheet 1 of 7 US 2002/0103109 A1 FIGURE 1A ACh FIGURE B O. - drug) (IM) Patent Application Publication Aug. 1, 2002 Sheet 2 of 7 US 2002/0103109 A1 FIGURE 2 FIGURE 3A 18MC GLU men -- GLY FIGURE 3B Patent Application Publication Aug. 1, 2002 Sheet 3 of 7 US 2002/0103109 A1 FIGURE 4 5HT BO 5HT 18MC ---a - --P 4-air A control f FIGURE 5 45 Baseline 40 Treatment 35 T T 2 5 Mec 1 18MC 1 DM 5 Mec 1 Mec 1 DM 5 18MC 1 DM 5 18MC 1 Treatment Patent Application Publication Aug. 1, 2002 Sheet 4 of 7 US 2002/0103109 A1 FIGURE 6 a 35 Baseline S Treatment 2 30 9. 3 25 2 20 E 15 a.E 10 s ES C as 5 s O s Mec 1 18Mc2 DM 5 Mec 1 Mec 1 DM 5 18MC 2 DM5 18MC 2 Treatment FIGURE 7 Baseline 1 2 O O is Treatment 1000 800 600 4 O O 2 O O s O Mec 1 18MC 2 DM 5 Mec 1 Mec 1 DM 5 18MC 2 DM 5 18MC 2 Treatment Patent Application Publication Aug. 1, 2002. Sheet 5 of 7 US 2002/0103109 A1 FIGURE 8 45 Baseline 40 Treatment g 35 o 30 2 25 E 3. old 20 S : 15 SO 10 : 5 : O Mec 1 18Mc DM5 Bup5 Mec1 DM5 18MC1 Bup5 Bup5 Bup5 Treatment FIGURE 9 35 Baseline a. Treatment O 30 E 25 S 2 20 E C 15 asE 10 5 e O Mec 1 18MC5 DM10 Bup 10 Mec1 DM10 18MC5 Bup 10 Bup10 Bup10 Treatment Patent Application Publication Aug. 1, 2002. Sheet 6 of 7 US 2002/0103109 A1 FIGURE 10 Baseline 1 2 O O Treatment 1000 800 i 600 400 200 Mec 1 18MC5 DM10 Bup 10 Mec1 DM10 18MC5 Bup10 Bup 10 Bup10 Treatment FIGURE 11 Baseline Treatment T 2O s 18M .5 DM.5 Mec. 1 Mec 1 DM 5 18MC5 DM 5 18 MC 5 Treatment Patent Application Publication Aug. 1, 2002 Sheet 7 of 7 US 2002/0103109 A1 FIGURE 12 Baseline Treatment 2O g 3. 38 g Mec. 1 18 MC5 DM 5 Bup5 Mec 1 DM.5 18MC.5 Bup5 Bup5 Bup5 Treatment US 2002/0103109 A1 Aug. 1, 2002 METHODS AND COMPOSITIONS FOR TREATING 0009. The present invention also relates to a method for ADDICTION DISORDERS treating an addiction disorder in a patient. The method 0001) The present invention claims the benefit of U.S. includes administering to the patient an OB, nicotinic Provisional Patent Application Serial No. 60/264,742, filed receptor antagonist under conditions effective to treat the Jan. 29, 2001, which is hereby incorporated by reference. patient's addiction disorder. 0002 The present invention was made with the support BRIEF DESCRIPTION OF THE DRAWINGS of the National Institute on Drug Abuse Grant No. DA 03817. The Federal Government may have certain rights in 0010 FIG. 1A is a graph of current vs. time showing this invention. whole-cell currents evoked by 1 mM ACh in transfected cells. FIG. 1B is a graph showing inhibition of 1 mM FIELD OF THE INVENTION ACh-evoked whole-cell currents by various concentrations of various drugs. 0003. The present application relates, generally, to meth ods of treating addiction disorders using CB. nicotinic 0011 FIG. 2 is a graph of whole-cell current vs. time receptor antagonists and to compositions useful in Such showing the effect of various drugs on whole-cell currents in treatmentS. cells expressing recombinant C.B. nicotinic receptorS. 0012 FIGS. 3A and 3B are graphs of whole-cell current BACKGROUND OF THE INVENTION VS. time showing the effect of various drugs on whole-cell 0004 Drug and alcohol addiction and/or abuse and/or currents in cells expressing recombinant NR1/2A(FIG.3A) dependency (collectively referred to herein as “addiction and NR1/2B (FIG. 3B) receptors. disorders’) is extremely common. Individuals Suffering 0013 FIG. 4 is a graph of whole-cell current vs. time from Such addictions are generally Subject to significant showing the effect of various drugs on whole-cell currents in Symptoms of withdrawal upon attempting to cease use of the cells expressing recombinant 5-HT receptors. addictive Substance (whether alcohol or drugs such as 0014 FIG. 5 is a bar graph showing the effects of various cocaine, heroine, nicotine, painkillers, etc.). A number of drugs and drug combinations on morphine Self-administra medical therapies have been tried with differing levels of tion. Success. Unfortunately, to date, none of these methods of treatment have been very successful. For this and other 0015 FIG. 6 is a bar graph showing the effects of various reasons, a need exists for improved methods for treating drugs and drug combinations on methamphetamine Self addictive disorders. administration. 0016 FIG. 7 is a bar graph showing the effects of various SUMMARY OF THE INVENTION drugs and drug combinations on responding for water. 0005 The present invention relates to a method for 0017 FIG. 8 is a bar graph showing the effects of various treating an addiction disorder in a patient. The method drugs and drug combinations on morphine Self-administra includes administering to the patient a first C.B. nicotinic tion. receptor antagonist and administering to the patient a Second Cla?s nicotinic receptor antagonist. The Second O?3 nico 0018 FIG. 9 is a bar graph showing the effects of various tinic receptor antagonist is different than the first CB drugs and drug combinations on methamphetamine Self nicotinic receptor antagonist, and the first CBA nicotinic administration. receptor antagonist and the Second O?3 nicotinic receptor 0019 FIG. 10 is a bar graph showing the effects of antagonist are administered Simultaneously or non-simulta various drugs and drug combinations on responding for neously. Water. 0006 The present invention also relates to a composition 0020 FIG. 11 is a bar graph showing the effects of which includes a first Of nicotinic receptor antagonist and various drugs and drug combinations on nicotine Self a Second CB nicotinic receptor antagonist. In this compo administration. Sition, the Second CB nicotinic receptor antagonist is different than the first C.B. nicotinic receptor antagonist. 0021 FIG. 12 is a bar graph showing the effects of various drugs and drug combinations on nicotine Self 0007. The present invention also relates to a composition administration. which includes a first compound Selected from the group consisting of mecamylamine, 18-methoxycoronaridine, DETAILED DESCRIPTION OF THE bupropion, dextromethorphan, dextrorphan, and phamaceu INVENTION tically acceptable Salts and Solvates thereof, and a Second C.B., compound selected from the group consisting of 0022. The present invention relates to a method for mecamylamine, 18-methoxycoronaridine, bupropion, dex treating an addiction disorder in a patient. The method tromethorphan, dextrorphan, and phamaceutically accept includes administering to the patient a first C.B. nicotinic able Salts and Solvates thereof. In this composition, the receptor antagonist and administering to the patient a Second Second compound is different than the first compound. Cla?s nicotinic receptor antagonist. 0008. The present invention also relates to a method of 0023. As used herein, “addiction disorder” is meant to evaluating a compound for its effectiveneSS in treating include a habitual or recurrent use of a Substance, Such as addiction disorders by assessing the compounds ability to Stimulants, nicotine (e.g., which is meant to include all bind to C.B. nicotinic receptors. forms of nicotine administration, Such as Smoking, chewing US 2002/0103109 A1 Aug. 1, 2002 tobacco, or other forms of nicotine administration), opioid (which is a metabolite of dextromethorphan). Other (e.g., morphine and heroin), amphetamines, cocaine, and examples of CB nicotinic receptor antagonists that are alcohol. It is meant to include, but is not meant to be limited useful in the practice of the present invention include to, a dependency on the Substance. Dependency is charac phamaceutically acceptable Salts and Solvates (the latter of terized by a patient's persistence in Substance use or abuse which is meant to include adducts) of mecamylamine, or the recurrence of Such use or abuse in the face of negative 18-methoxycoronaridine, bupropion, dextromethorphan, Social or medical consequences of this use or abuse or in and dextrorphan.
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