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Individually Adapted Therapy of Alcoholism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00317031
First Posted: April 21, 2006
Last Update Posted: June 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Federal Ministry of Education and Research
Merck Sharp & Dohme Corp.
Dupont Applied Biosciences
Information provided by:
Central Institute of Mental Health, Mannheim
  Purpose
The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics.

Condition Intervention Phase
Alcoholism Drug: Acamprosate or Naltrexone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Individually Adapted Therapy of Alcoholism: Clinical Studies

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 435
Study Start Date: November 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Acamprosate
Drug: Acamprosate or Naltrexone
mg&d 90 days
Active Comparator: 2
Naltrexone
Drug: Acamprosate or Naltrexone
mg&d 90 days
Placebo Comparator: 3
Placebo
Drug: Acamprosate or Naltrexone
mg&d 90 days

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants will have a current DSM-IV/ICD 10 diagnosis of alcohol dependence.
  2. Participants must have had a minimum of 14 drinks (females) or 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to initiation of abstinence, and must have had two or more days of heavy drinking (defined as 4 drinks for females and 5 drinks for males) in the 90-day period prior to initiation of abstinence.
  3. Participants must have had a minimum of 72 hours of abstinence and no significant withdrawal symptoms (CIWA < 8) prior to randomization.
  4. At least 2 weeks of inpatient treatment.
  5. Participants can be abstinent for a maximum of 28 days prior to randomization.
  6. Participants are willing not to seek additional psychotherapy during the first 6 months of study except attendance of mutual help groups.
  7. Participants have to sign a witnessed declaration of informed consent.

Exclusion Criteria:

  1. Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, or a psychological disorder for whom medication is indicated, but no other Axis I disorders that are not medicated and are not severe enough to require medications.
  2. Participants who require psychopharmacotherapy.
  3. Participants who require therapy with any medications which pose safety issues.
  4. Participants with a current abuse of any psychoactive drug and who show a positive drug test on an urine screen.
  5. Participants with a lifetime diagnosis of dependence on any psycho-active drug except for nicotine or habitual caffeine use.
  6. Participants who have significant medical disorders which would increase the potential risk of the study treatment or interfere with the study participation.
  7. Participants with abnormal AST or ALT (more than 5 times the normal level).
  8. Participants who are pregnant or nursing infant(s).
  9. Women during childbearing years without an effective contraceptive method.
  10. Participants developing sensitivity to the study medication.
  11. Participants who are illiterate or are unable to read and write German.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317031


Locations
Germany
Department of Psychiatry, University of Regensburg
Regensburg, Bayern, Germany, 93053
Department of Psychiatry, University of Freiburg
Freiburg, BW, Germany, 79104
Department of Psychiatry, University of Heidelberg
Heidelberg, BW, Germany, 69115
Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health
Mannheim, BW, Germany, 68159
Department of Psychiatry, University of Tübingen
Tuebingen, BW, Germany, 72076
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Federal Ministry of Education and Research
Merck Sharp & Dohme Corp.
Dupont Applied Biosciences
Investigators
Principal Investigator: Karl F. Mann, MD Central Institute of Mental Health, J5, 68159 Mannheim, Germany
Principal Investigator: Michael N. Smolka, MD Central Insitute of Mental Health, J5, 68159 Mannheim, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kiefer, Falk, Central Institute of Mental Health (CIMH), Mannheim
ClinicalTrials.gov Identifier: NCT00317031     History of Changes
Other Study ID Numbers: PREDICT
First Submitted: April 19, 2006
First Posted: April 21, 2006
Last Update Posted: June 27, 2008
Last Verified: June 2008

Keywords provided by Central Institute of Mental Health, Mannheim:
Alcoholism
Drug Therapy

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Acamprosate
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents