Nicotine addiction treatment

Abstract

The present invention encompasses methods of treating patients for tobacco addiction and nicotine addiction, for palliating the effects of nicotine withdrawal, for providing or facilitating the effects of smoking cessation therapies and as long-term smoking cessation maintenance therapy. The invention also includes related pharmaceutical compositions comprising nicotine receptor antagonists and either an anti-depressant or an anti-anxiety drug. Specific combinations of drugs (mecamylamine HCl and bupropion HCl) as well as mecamylamine in combination with certain drug classes (e.g., anti-anxiety drugs and anti-depressants) comprise the pharmaceutical compositions disclosed. These compositions are also contemplated for use in the treatment of cocaine addiction and the treatment of alcohol dependence.

What is claimed:  
     
         1 . A pharmaceutical composition for treating tobacco addiction or nicotine addiction, palliating nicotine withdrawal symptoms or facilitating smoking cessation comprising a therapeutically effective combination of a nicotine receptor antagonist and either an anti-depressant or an anti-anxiety drug.  
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein said anti-depressant is selected from the group consisting of bupropion, doxepin, desipramine, clomipramine, imipramine, nortriptyline, amitriptyline, protriptyline, trimipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, phenelzine, tranylcypromine, amoxapine, maprotiline, trazodone, venlafaxine, mirtazapine, their pharmaceutically active salts and their optical isomers.  
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein said anti-depressant is either bupropion or a pharmaceutically acceptable salt thereof, or doxepin or a pharmaceutically acceptable salt thereof.  
     
     
         4 . The pharmaceutical composition of  claim 3 , wherein said pharmaceutically acceptable salt of bupropion is bupropion HCl.  
     
     
         5 . The pharmaceutical composition of  claim 3 , wherein said pharmaceutically acceptable salt of doxepin is doxepin HCl.  
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the nicotine receptor antagonist is selected from the group consisting of: mecamylamine, amantadine, pempidine, dihydro-beta-erythroidine, hexamethonium, erysodine, chlorisondamine, trimethaphan camsylate, tubocurarine chloride, d-tubocurarine, their pharmaceutically acceptable salts and their optical isomers.  
     
     
         7 . The pharmaceutical composition of  claim 6 , wherein said nicotine receptor antagonist is mecamylamine or a pharmaceutically acceptable salt thereof.  
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein said pharmaceutically acceptable salt of mecamylamine is mecamylamine HCl.  
     
     
         9 . The pharmaceutical composition of  claim 1 , wherein the anti-anxiety agent is selected from the group consisting of hydroxyzine, meprobamate, buspirone, their pharmaceutical salts and their optical isomers.  
     
     
         10 . The pharmaceutical composition of  claim 1 , wherein said anti-anxiety agent is buspirone or a pharmaceutically acceptable salt thereof.  
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein said pharmaceutically acceptable salt of buspirone is buspirone HCl.  
     
     
         12 . The pharmaceutical composition of  claim 3 , wherein said bupropion or a pharmaceutically acceptable salt thereof is formulated to deliver a daily dose of about 50 mg to about 300 mg.  
     
     
         13 . The pharmaceutical composition of  claim 3 , wherein said bupropion or a pharmaceutically acceptable salt thereof is formulated to deliver a daily dose of about 50 mg to about 150 mg.  
     
     
         14 . The pharmaceutical composition of  claim 7 , wherein said mecamylamine or a pharmaceutically acceptable salt thereof is formulated to deliver a daily dose of about 1 mg to about 25 mg.  
     
     
         15 . The pharmaceutical composition of  claim 7 , wherein said mecamylamine or a pharmaceutically acceptable salt thereof is formulated to deliver a daily dose of about 1 mg to about 10 mg.  
     
     
         16 . The pharmaceutical composition of  claim 10 , wherein said buspirone or a pharmaceutically acceptable salt thereof is formulated to deliver a daily dose of about 5 mg to about 60 mg.  
     
     
         17 . The pharmaceutical composition of  claim 10 , wherein said buspirone or a pharmaceutically acceptable salt thereof is formulated to deliver a daily dose of about 5 mg to about 10 mg.  
     
     
         18 . A method of treating tobacco addiction or nicotine addiction, palliating nicotine withdrawal symptoms or facilitating smoking cessation comprising the step of administering to a patient the pharmaceutical composition of any of  claims 1  to  17 .  
     
     
         19 . The method of  claim 18 , comprising the further step of administering nicotine replacement therapy.  
     
     
         20 . The method of  claim 19 , wherein said nicotine replacement therapy is a nicotine transdermal patch.  
     
     
         21 . A pharmaceutical composition for treating cocaine addiction and associated withdrawal effects comprising a therapeutically effective combination of a nicotine receptor antagonist and either an anti-depressant or an anti-anxiety drug.  
     
     
         22 . The pharmaceutical composition for treating cocaine addiction and associated withdrawal effects of  claim 21 , wherein the anti-depressant is selected from the group consisting of: bupropion or a pharmaceutically active salt thereof, and doxepin or a pharmaceutically active salt thereof.  
     
     
         23 . The pharmaceutical composition for treating cocaine addiction and associated withdrawal effects of  claim 22 , wherein the anti-anxiety drug is buspirone or a pharmaceutically active salt thereof.  
     
     
         24 . A method of treating cocaine addiction and associated withdrawal effects comprising the step of administering to a patient the pharmaceutical composition of any of  claims 21  to  23 .  
     
     
         25 . A pharmaceutical composition for treating alcohol dependence and associated withdrawal effects comprising a therapeutically effective combination of nicotine receptor antagonist and either an anti-depressant or an anti-anxiety drug.  
     
     
         26 . The pharmaceutical composition for treating alcohol dependence and associated withdrawal effects of  claim 25 , wherein the anti-depressant is selected from the group consisting of: bupropion or a pharmaceutically active salt thereof, and doxepin or a pharmaceutically active salt thereof.  
     
     
         27 . The pharmaceutical composition for treating alcohol dependence and associated withdrawal effects of  claim 25 , wherein the anti-anxiety drug is buspirone or a pharmaceutically active salt thereof.  
     
     
         28 . A method of treating alcohol dependence and associated withdrawal effects comprising the step of administering to a patient the pharmaceutical composition of any of  claims 25  to  27 .