Therapy and Prevention of Problem Drinking

Abstract

The present invention provides methods for the therapy and prevention of problem drinking in alcohol-dependent and non-dependent subjects and those at risk of developing problem drinking behavior, and compositions of matter comprising oxytocin or an analog or derivative thereof or an agonist or partial agonist of an oxytocin receptor that are useful in preventing or treating problem drinking.

1 . A method of treatment or prophylaxis of problem drinking, said method comprising administering to a subject an amount of a composition comprising oxytocin or an analog or derivative thereof or an oxytocin receptor agonist for a time and under conditions sufficient to reduce alcohol consumption by the subject to a level that constitutes moderate drinking behavior or abstinence from alcohol, or to inhibit or prevent alcohol consumption by the subject, thereby treating or preventing problem drinking in the subject. 
     
     
         2 . The method according to  claim 1 , wherein the subject is a subject whose behavior constitutes acute hazardous drinking or acute harmful drinking or chronic hazardous drinking or chronic harmful drinking as set forth in Table 1 hereof. 
     
     
         3 . The method according to  claim 1 , wherein the subject has no apparent alcohol dependency. 
     
     
         4 . The method according to  claim 3 , wherein the subject is a non-dependent problem drinker. 
     
     
         5 . The method according to  claim 1 , wherein the subject suffers from an alcohol dependence syndrome. 
     
     
         6 . The method according to  claim 1 , wherein the administration of oxytocin or an analog or derivative thereof or an oxytocin receptor agonist reduces alcohol intake in the medium or long term or promotes abstinence in the medium or long term or reduces or prevents an incremental alcohol consumption in the medium or long term. 
     
     
         7 .- 8 . (canceled) 
     
     
         9 . A method of promoting moderate drinking behavior in a subject, said method comprising administering an amount of a composition comprising oxytocin or an analog or derivative thereof or an oxytocin receptor agonist for a time and under conditions sufficient to produce a maximum alcohol intake by the subject constituting moderate drinking behavior. 
     
     
         10 . The method according to  claim 9 , wherein the subject exhibits a problem drinking behavior and wherein the administration of oxytocin or an analog or derivative thereof or an oxytocin receptor agonist reduces alcohol intake by the subject to a level constituting moderate drinking behavior. 
     
     
         11 . The method according to  claim 10 , wherein the administration of oxytocin or an analog or derivative thereof or an oxytocin receptor agonist reduces alcohol intake in the medium or long term, or reduces incremental alcohol consumption in the medium or long term. 
     
     
         12 . (canceled) 
     
     
         13 . The method according to  claim 10 , wherein the subject is a subject whose behavior constitutes acute hazardous drinking or acute harmful drinking or chronic hazardous drinking or chronic harmful drinking as set forth in Table 1 hereof. 
     
     
         14 . The method according to  claim 13 , wherein the subject has no apparent alcohol dependency. 
     
     
         15 . The method according to  claim 14 , wherein the subject is a non-dependent problem drinker. 
     
     
         16 . The method according to  claim 14 , wherein the subject suffers from an alcohol dependence syndrome. 
     
     
         17 . The method according to  claim 10 , wherein the subject is at risk of developing problem drinking behavior and wherein the administration of oxytocin or an analog or derivative thereof or an oxytocin receptor agonist prevents or reduced an increment of alcohol intake by the subject beyond a level constituting moderate drinking behavior. 
     
     
         18 . The method according to  claim 17 , wherein the subject has a family history of problem drinking, alcoholism or alcohol misuse that renders the subject susceptible to developing problem drinking behavior. 
     
     
         19 . The method according to  claim 17 , wherein the administration of oxytocin or an analog or derivative thereof or an oxytocin receptor agonist prevents an incremental alcohol consumption by the subject in the medium or long term. 
     
     
         20 . A method of enhancing abstinence from alcohol in a subject in relapse from problem drinking, said method comprising administering an amount of a composition comprising oxytocin or an analog or derivative thereof or an oxytocin receptor agonist for a time and under conditions sufficient to extend abstinence from alcohol by the subject, optionally without adverse withdrawal symptom(s). 
     
     
         21 . A composition comprising oxytocin or an analog or derivative thereof or an agonist or partial agonist of an oxytocin receptor, said composition being for use in a method of therapy or prophylaxis according to  claim 1 . 
     
     
         22 . The composition according to  claim 21  when formulated for oral administration to a subject. 
     
     
         23 . The composition according to  claim 21  when formulated for administration to a subject by injection. 
     
     
         24 . The composition according to  claim 21  when formulated for administration to a subject by inhalation. 
     
     
         25 . Use of a composition comprising oxytocin or an analog or derivative thereof or an agonist or partial agonist of an oxytocin receptor in the preparation of a medicament for therapy or prophylaxis of problem drinking or for promoting moderate drinking behavior in a subject. 
     
     
         26 . The use according to  claim 25 , wherein the medicament is for therapy or prophylaxis in a method according to  claim 1 . 
     
     
         27 . The use according to  claim 25 , wherein the medicament is formulated for oral administration to a subject or is formulated for administration to a subject by injection or is formulated for administration to a subject by inhalation. 
     
     
         28 .- 29 . (canceled)