Individually Adapted Therapy of Alcoholism

This study has been completed.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Merck Sharp & Dohme Corp.
Dupont Applied Biosciences
Information provided by:
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00317031
First received: April 19, 2006
Last updated: June 26, 2008
Last verified: June 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • time to first alcohol consumption [ Time Frame: 06/2008 ] [ Designated as safety issue: No ]
  • percentage of days of complete abstinence from alcohol [ Time Frame: 06/2008 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided by Central Institute of Mental Health, Mannheim

Additional 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
Study First Received: April 19, 2006
Last Updated: June 26, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Acamprosate
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Alcohol Deterrents

ClinicalTrials.gov processed this record on April 17, 2014