Clinical Trial: Individually Adapted Therapy of Alcoholism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Individually Adapted Therapy of Alcoholism: Clinical Studies

Brief Summary: The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics.

Detailed Summary: The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics. The secondary objective is to establish an association between patients' motivational type and drug effects. The aim is to improve alcoholism treatment by identifying characteristics for response to specific pharmacological relapse prevention. Such items could allow for an individually adapted pharmacotherapy of alcoholism. Specifically, we will study the possible dependence of the efficacy of naltrexone and/or acamprosate on different motivational types (reward versus relief craving) and genetic profiles referring to glutamatergic and opioidergic candidate genes. Lastly, the longterm costs and cost-effectiveness of the different treatment strategies for alcoholics chosen in our study are established.
Sponsor: Central Institute of Mental Health, Mannheim

Current Primary Outcome: time to relapse to heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males) [ Time Frame: 06/2008 ]

Original Primary Outcome: time to relapse to heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males)

Current Secondary Outcome:

  • percentage of days without heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males) [ Time Frame: 06/2008 ]
  • time to first alcohol consumption [ Time Frame: 06/2008 ]
  • percentage of days of complete abstinence from alcohol [ Time Frame: 06/2008 ]


Original Secondary Outcome:

  • percentage of days without heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males)
  • time to first alcohol consumption
  • percentage of days of complete abstinence from alcohol


Information By: Central Institute of Mental Health, Mannheim

Dates:
Date Received: April 19, 2006
Date Started: November 2002
Date Completion:
Last Updated: June 26, 2008
Last Verified: June 2008