Individually Adapted Therapy of Alcoholism

NCT00317031 | Completed Phase 4

• 1 other identifier: PREDICT
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Alcoholism

Keywords

Alcoholism; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  06/2008

Secondary Outcomes (3)

• 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)

  06/2008

• time to first alcohol consumption

  06/2008

• percentage of days of complete abstinence from alcohol

  06/2008

Study Arms (3)

1

ACTIVE COMPARATOR

Acamprosate

Drug: Acamprosate or Naltrexone

2

ACTIVE COMPARATOR

Naltrexone

Drug: Acamprosate or Naltrexone

3

PLACEBO COMPARATOR

Placebo

Drug: Acamprosate or Naltrexone

Interventions

Acamprosate or Naltrexone DRUG

mg\&d 90 days

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• German Federal Ministry of Education and Research: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Dupont Applied Biosciences: collaborator

Study Sites (5)

Department of Psychiatry, University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Department of Psychiatry, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

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

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Department of Psychiatry, University of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Department of Psychiatry, University of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (4)

• 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.

  PMID: 25593047 DERIVED

• 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.

  PMID: 25421512 DERIVED

• 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.

  PMID: 25269022 DERIVED

• 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.

  PMID: 23231446 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Acamprosate; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: November 1, 2002
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 27, 2008

Record last verified: 2008-06

Locations

DE (5)