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Individually Adapted Therapy of Alcoholism

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Acamprosate or Naltrexone
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Drug Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants will have a current DSM-IV/ICD 10 diagnosis of alcohol dependence. 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. Participants must have had a minimum of 72 hours of abstinence and no significant withdrawal symptoms (CIWA < 8) prior to randomization. At least 2 weeks of inpatient treatment. Participants can be abstinent for a maximum of 28 days prior to randomization. Participants are willing not to seek additional psychotherapy during the first 6 months of study except attendance of mutual help groups. Participants have to sign a witnessed declaration of informed consent. Exclusion Criteria: 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. Participants who require psychopharmacotherapy. Participants who require therapy with any medications which pose safety issues. Participants with a current abuse of any psychoactive drug and who show a positive drug test on an urine screen. Participants with a lifetime diagnosis of dependence on any psycho-active drug except for nicotine or habitual caffeine use. Participants who have significant medical disorders which would increase the potential risk of the study treatment or interfere with the study participation. Participants with abnormal AST or ALT (more than 5 times the normal level). Participants who are pregnant or nursing infant(s). Women during childbearing years without an effective contraceptive method. Participants developing sensitivity to the study medication. Participants who are illiterate or are unable to read and write German.

Sites / Locations

  • Department of Psychiatry, University of Regensburg
  • Department of Psychiatry, University of Freiburg
  • Department of Psychiatry, University of Heidelberg
  • Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health
  • Department of Psychiatry, University of Tübingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Acamprosate

Naltrexone

Placebo

Outcomes

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)

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 to first alcohol consumption
percentage of days of complete abstinence from alcohol

Full Information

First Posted
April 19, 2006
Last Updated
June 26, 2008
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
German Federal Ministry of Education and Research, Merck Sharp & Dohme LLC, Dupont Applied Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00317031
Brief Title
Individually Adapted Therapy of Alcoholism
Official Title
Individually Adapted Therapy of Alcoholism: Clinical Studies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
German Federal Ministry of Education and Research, Merck Sharp & Dohme LLC, Dupont Applied Biosciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcoholism, Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Acamprosate
Arm Title
2
Arm Type
Active Comparator
Arm Description
Naltrexone
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Acamprosate or Naltrexone
Intervention Description
mg&d 90 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
time to first alcohol consumption
Time Frame
06/2008
Title
percentage of days of complete abstinence from alcohol
Time Frame
06/2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will have a current DSM-IV/ICD 10 diagnosis of alcohol dependence. 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. Participants must have had a minimum of 72 hours of abstinence and no significant withdrawal symptoms (CIWA < 8) prior to randomization. At least 2 weeks of inpatient treatment. Participants can be abstinent for a maximum of 28 days prior to randomization. Participants are willing not to seek additional psychotherapy during the first 6 months of study except attendance of mutual help groups. Participants have to sign a witnessed declaration of informed consent. Exclusion Criteria: 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. Participants who require psychopharmacotherapy. Participants who require therapy with any medications which pose safety issues. Participants with a current abuse of any psychoactive drug and who show a positive drug test on an urine screen. Participants with a lifetime diagnosis of dependence on any psycho-active drug except for nicotine or habitual caffeine use. Participants who have significant medical disorders which would increase the potential risk of the study treatment or interfere with the study participation. Participants with abnormal AST or ALT (more than 5 times the normal level). Participants who are pregnant or nursing infant(s). Women during childbearing years without an effective contraceptive method. Participants developing sensitivity to the study medication. Participants who are illiterate or are unable to read and write German.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl F. Mann, MD
Organizational Affiliation
Central Institute of Mental Health, J5, 68159 Mannheim, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael N. Smolka, MD
Organizational Affiliation
Central Insitute of Mental Health, J5, 68159 Mannheim, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Department of Psychiatry, University of Freiburg
City
Freiburg
State/Province
BW
ZIP/Postal Code
79104
Country
Germany
Facility Name
Department of Psychiatry, University of Heidelberg
City
Heidelberg
State/Province
BW
ZIP/Postal Code
69115
Country
Germany
Facility Name
Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health
City
Mannheim
State/Province
BW
ZIP/Postal Code
68159
Country
Germany
Facility Name
Department of Psychiatry, University of Tübingen
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25593047
Citation
Reinhard I, Lemenager T, Fauth-Buhler M, Hermann D, Hoffmann S, Heinz A, Kiefer F, Smolka MN, Wellek S, Mann K, Vollstadt-Klein S. A comparison of region-of-interest measures for extracting whole brain data using survival analysis in alcoholism as an example. J Neurosci Methods. 2015 Mar 15;242:58-64. doi: 10.1016/j.jneumeth.2015.01.001. Epub 2015 Jan 12.
Results Reference
derived
PubMed Identifier
25421512
Citation
Mann K, Vollstadt-Klein S, Reinhard I, Lemenager T, Fauth-Buhler M, Hermann D, Hoffmann S, Zimmermann US, Kiefer F, Heinz A, Smolka MN. Predicting naltrexone response in alcohol-dependent patients: the contribution of functional magnetic resonance imaging. Alcohol Clin Exp Res. 2014 Nov;38(11):2754-62. doi: 10.1111/acer.12546.
Results Reference
derived
PubMed Identifier
25269022
Citation
Lemenager T, Hill H, Reinhard I, Hoffmann S, Zimmermann US, Hermann D, Smolka MN, Kiefer F, Vollstadt-Klein S, Heinz A, Mann K. Association between alcohol-cue modulated startle reactions and drinking behaviour in alcohol dependent patients - results of the PREDICT study. Int J Psychophysiol. 2014 Dec;94(3):263-71. doi: 10.1016/j.ijpsycho.2014.09.009. Epub 2014 Sep 28.
Results Reference
derived
PubMed Identifier
23231446
Citation
Mann K, Lemenager T, Hoffmann S, Reinhard I, Hermann D, Batra A, Berner M, Wodarz N, Heinz A, Smolka MN, Zimmermann US, Wellek S, Kiefer F, Anton RF; PREDICT Study Team. Results of a double-blind, placebo-controlled pharmacotherapy trial in alcoholism conducted in Germany and comparison with the US COMBINE study. Addict Biol. 2013 Nov;18(6):937-46. doi: 10.1111/adb.12012. Epub 2012 Dec 12.
Results Reference
derived

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Individually Adapted Therapy of Alcoholism

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