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Individually Adapted Therapy of Alcoholism

NCT ID: NCT00317031

Last Updated: 2008-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Alcoholism

Keywords

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Alcoholism Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Acamprosate

Group Type ACTIVE_COMPARATOR

Acamprosate or Naltrexone

Intervention Type DRUG

mg\&d 90 days

2

Naltrexone

Group Type ACTIVE_COMPARATOR

Acamprosate or Naltrexone

Intervention Type DRUG

mg\&d 90 days

3

Placebo

Group Type PLACEBO_COMPARATOR

Acamprosate or Naltrexone

Intervention Type DRUG

mg\&d 90 days

Interventions

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Acamprosate or Naltrexone

mg\&d 90 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Dupont Applied Biosciences

INDUSTRY

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Central Institute of Mental Health (CIMH), Mannheim

Principal Investigators

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Karl F. Mann, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, J5, 68159 Mannheim, Germany

Michael N. Smolka, MD

Role: PRINCIPAL_INVESTIGATOR

Central Insitute of Mental Health, J5, 68159 Mannheim, Germany

Locations

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Department of Psychiatry, University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Department of Psychiatry, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health

Mannheim, Baden-Wurttemberg, Germany

Site Status

Department of Psychiatry, University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Department of Psychiatry, University of Regensburg

Regensburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25593047 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25421512 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25269022 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23231446 (View on PubMed)

Other Identifiers

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PREDICT

Identifier Type: -

Identifier Source: org_study_id