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(12) Patent Application Publication (10) Pub. No.: US 2012/0302592 A1 Johnson Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2012/0302592 A1 Johnson Et Al US 20120302592A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0302592 A1 Johnson et al. (43) Pub. Date: Nov. 29, 2012 (54) TOPIRAMATE PLUS NALTREXONE FOR (60) Provisional application No. 60/898,527, filed on Jan. THE TREATMENT OF ADDICTIVE 31, 2007. DSORDERS (75) Inventors: Bankole A. Johnson, O O Charlottesville, VA (US); Nassima Publication Classification Ait-Daoud Tiouririne, (51) Int. Cl. Charlottesville, VA (US); Wendy J. A63L/485 (2006.01) Lynch, Charlottesville, VA (US) A6IP 25/36 (2006.01) (73) Assignee: University of Virginia Patent A6IP 25/34 (2006.01) Foundation, Charlottesville, VA A6IP 25/30 (2006.01) (US) A6IP 25/32 (2006.01) (21) Appl. No.: 13/569.465 (52) U.S. Cl. ........................................................ S14/282 (22) Filed: Aug. 8, 2012 Related U.S. Application Data 57 ABSTRACT (63) Continuation of application No. 12/525.320, filed on (57) Jul. 31, 2009, now abandoned, filed as application No. The present invention provides for the use of combinations of PCT/US2008/052628 on Jan. 31, 2008. drugs to treat addictive disorders. Patent Application Publication Nov. 29, 2012 Sheet 1 of 12 US 2012/0302592 A1 3 Drinks I EEEE Day 2 EEEE O EEEE Plac Ond 1 Ond 4 Ond 16 Plac Ond 1 Ond 4. Ond 16 Start of double blind End of study Placebo (Plac) gieron 1 ug/kg b.i.d. n Ondansetron 4 ug/kg I Ondansetron 16 ug/kg b.i.d. b.i.d. (Ond 4) (Ond 16) FIG. 1A Patent Application Publication Nov. 29, 2012 Sheet 2 of 12 US 2012/0302592 A1 Mean Drinks I Day 2 Plac Ond 1 Ond 4 Ond 16 Plac Ond 1 Ond 4 Ond 16 Start of double blind End of study Placebo (Plac) gieron 1 ug/kg b.i.d. n Ondansetron 4 pug/kg I Ondansetron 16 lug/kg b.i.d. b.i.d. (Ond 4) (Ond 16) F.G. 1B Patent Application Publication Nov. 29, 2012 Sheet 3 of 12 US 2012/0302592 A1 0.3 Mean 0.2 Log CDT 0.1 Ratio -0.0 -0.1 -0.2 -0.3 -0.4 Plac Ond 1 Ond 4 Ond 16 Ondansetron doses in lug/kg b.i.d. Placebo (Plac) Ondansetron 1 ug/kg b.i.d. (Ond 4) Ondansetron 4 ug/kg I Ondansetron 16 pug/kg b.i.d. b.i.d. (Ond 4) (Ond 16) FIG. 2A Patent Application Publication Nov. 29, 2012 Sheet 4 of 12 US 2012/0302592 A1 Mean 0.1 Log CDT -0.0 Ratio Plac Ond 1 Ond 4 Ond 16 Ondansetron doses in ug/kg b.i.d. Placebo (Plac) getonn 1 ug/kg b.i.d. Ondansetron 4 ug/kg I Ondansetron 16 ug/kg b.i.d. b.i.d. (Ond 4) (Ond 16) FIG. 2B Patent Application Publication Nov. 29, 2012 Sheet 5 of 12 US 2012/0302592 A1 6 O Group Mean -O-- 0.1 Naitrexone 4O -- 0.3 Naitrexone 0 Naitrexone 2O 3.0 Naitrexone O AS S) (S N) &S) Sy 1S (S) co & AS S AeS 28 & & & AS Time (10 minute time blocks) FIG. 3 Patent Application Publication Nov. 29, 2012 Sheet 6 of 12 US 2012/0302592 A1 1 O 9 Mean 8 drinks/ drinking 5 day 4 3 2 1. O O 1 2 3 4 5 6 7 8 Study Weeks Baseli a SCI116 Start of double-blind O Ondansetron 4 u g/kg b.i.d. + Naltrexone 25 mg b.i.d. group -O-Placebo group FIG. 4A Patent Application Publication Nov. 29, 2012 Sheet 7 of 12 US 2012/0302592 A1 12 11 1O Mean drinks/ drinking day O O 1. 2 3 4. 5 6 7 8 A A Study Weeks Baseline Start of double-blind O Ondansetron 4 u g/kg b.i.d. + Naltrexone 25 mg b.i.d. group -O-Placebo group FIG. 4B Patent Application Publication Nov. 29, 2012 Sheet 8 of 12 US 2012/0302592 A1 24 16 12 1 2 3 4 5 6 7 8 9 10 11 12 Week of Study A Placebo O 2.5 mg Rit a 5.0 mg Rit FIG.S Patent Application Publication Nov. 29, 2012 Sheet 9 of 12 US 2012/0302592 A1 Alcohol Dependent patients N=360 Early Onset Alcoholics late Onset Alcoholics (EOA) N=180 (LOA) N=180 Alcoholism onsets 25 years Alcoholism on Sct > 25 years a High family history of alcoholism "Less family history of alcoholism in 1st degree relatives in 1st degree relatives Antisocial behaviors and symptoms "Few antisocial bchaviors and Symptoms Cognitive Bchavioral Therapy Cognitive Behavioral Therapy Placcbo Ondansetron Ondansetron Ondansetron Ondansetron -- -- -- Placebo Naltrexone Placcbo Naltrexone Naltrexone Placcbo Naltrexone N=45 N=45 N=45 FIG. 6 Patent Application Publication Nov. 29, 2012 Sheet 10 of 12 US 2012/0302592 A1 N Study & years S. N N 0 1 2 3 4 5 6 7 8 9 10 Subject Enrolled Completed FIG. 7 Patent Application Publication Nov. 29, 2012 Sheet 11 of 12 US 2012/0302592 A1 Effect of Naltrexonel Topiramate on 2O Alcohol Consumption vehicle 5 Top 10 Top Nar Nairo Top 1 Nal -24 5 Top FG. 8 Patent Application Publication Nov. 29, 2012 Sheet 12 of 12 US 2012/0302592 A1 Eises to Frofia Cofi ef: S to hippoca. ERS N. Arcuatus 5HT3 receptors Š 3- endorphifts S&rester ST3 receptoE facilitate (ABA intereiros Bopanine s: Afferent from the Hippocampus to the N. Accinaens FIG. 9 US 2012/0302592 A1 Nov. 29, 2012 TOPIRAMATE PLUS NALTREXONE FOR development and maintenance of alcohol dependence. To THE TREATMENT OF ADDCTIVE date, most pharmacotherapy trials have focused on single DISORDERS pharmacological agents. However, because of the failure to find consistent results with these drug therapies, investigating CROSS REFERENCE TO RELATED the efficacy of combining drugs that target multiple neu APPLICATIONS rotransmitter systems or genes is perhaps more important to the development of future pharmacotherapies for treatment of 0001. This application is entitled to priority pursuant to 35 alcohol dependence and treatment of other addictive disor U.S.C. S 119(e) to U.S. provisional patent application No. ders and impulse control disorders. 607898,527, filed on Jan. 31, 2007. The entire disclosure of 0006 Various medications and behavioral therapy have the afore-mentioned patent application is incorporated herein been used to treat alcohol dependence. The neuronal targets by reference. of alcohol include many neurotransmitter systems and the FIELD OF THE INVENTION molecules participating in or regulating the systems, includ ing GABA, glutamate, DA, opioids, and serotonin (for a 0002 The present invention relates generally to the use of review see Johnson, 2004, Expert Opin. Pharmacother. 5:9: combination therapies to treat addiction-related diseases and 1943-1955). disorders and impulse control disorders, particularly alcohol 0007. Despite the number of studies performed in this related diseases and disorders. area, few drugs for alcohol dependence are approved in the U.S. The approved drugs are disulfuram, naltrexone, Vivit BACKGROUND rex R/Vivitrol(R) (a long-acting depot formulation of naltrex 0003) Neuroscientific advances have increased greatly our one), and acamprosate. Disulfuram is an irreversible inhibitor understanding of the pharmaco-behavioral effects of various of aldehyde dehydrogenase leading to increased levels of neurotransmitter systems in the acquisition and maintenance acetaldehyde, a toxic intermediate in alcohol metabolism. of alcohol dependence. Medications that interact either Patients who take disulfuram and drink alcohol experience an directly or indirectly with neurotransmitters that modulate increased dilation of arterial and capillary tone producing cortico-mesolimbic dopamine (CMDA) neurons have been hypotension, nausea, vomiting, flushing, headache and pos central to most pharmacological strategies in the last decade. sibly in some, worse symptoms. Therefore, the concept Direct dopamine (DA) antagonists have failed to demonstrate behind the use of disulfuram is that the alcohol-dependent therapeutic efficacy consistently, possibly because the high individual associates drinking with unpleasant adverse events degree of neuroadaptation that occurs with direct post-Syn and, as a result, avoids further alcohol consumption. Never aptic blockade mitigates against any long-standing therapeu theless, recent research shows that disulfuram has limited tic effect. utility because compliance is low unless it is administered by 0004 Three major issues have promulgated scientific a partner or spouse. interest in the development of medicational adjuncts to psy 0008 Naltrexone's principal site of action is at the Lopioid chosocial or behavioral therapy for the treatment of alcohol receptors in the mesolimbic pathway, putatively blocking the ism. First, up to one-half of alcoholics relapse shortly after reinforcing effects of alcohol by decreasing DA release in the detoxification, psychosocial, or behavioral treatment. Sec nucleus accumbens (NAc). Studies using naltrexone report ond, advances in the neurosciences have implicated several that the opioid antagonist is more effective than placebo in target neurotransmitter systems such as those within the reducing craving and heavy drinking, and increasing the per mesocorticolimbic pathway which mediate some of alcohol's centage of non-drinking days, but does not necessarily rewarding effects associated with its abuse liability. Selective enhance abstinence. Although these studies Support the effi medications designed to oppose these neuronal systems may cacy of naltrexone, others report limited utility for the drug enhance the effectiveness of alcoholism treatments. Third, only when individuals were highly compliant or even not at Some alcoholics may possess biological abnormalities which all. predispose them to disease. These biologically-Vulnerable 0009 Acamprosate, a structural analogue of GABA, was alcoholics might benefit from specific adjunctive medication approved to promote abstinence in recently detoxified indi targeted towards correcting or ameliorating the underlying viduals. Although the exact mechanism of action is unknown, abnormalities. Since these abnormalities involve several neu the drug is thought to restore glutamatergic-mediated inhibi rotransmitters, combinations of medications targeting spe tory and excitatory neurotransmission in the NAc.
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