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Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study

NCT00561587 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-04-18

No results posted yet for this study

Summary

Due to Quetiapine's particulars and the promising receptor profile, we want to examine the efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind pilot study.

We further want to compare the course of the above mentioned craving and affective symptoms under medication with quetiapine / matching placebo.

Conditions

  • Alcohol Relapse Prevention
  • Alcoholism
  • Alcohol Drinking
  • Alcohol Consumption
  • Alcohol Abuse

Interventions

DRUG

Seroquel®

dosage form: oral, adjusted in the range of 25 to max. 300 mg /day

Sponsors & Collaborators

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

    lead OTHER

Principal Investigators

  • Karl Mann, MD PhD · Dept. of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Mannheim, University of Heidelberg, Germany

  • Bernhard Croissant, MD PhD · Dept. of Psychiatry and Psychotherapy, Hospital Sigmaringen, University of Tuebingen

  • Ursula Havemann-Reinecke, MD PhD · Department of Psychiatry and Psychotherapy, Georg-August-University, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-08-31
Completion
2010-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00561587 on ClinicalTrials.gov