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

NCT00561587 | Completed Phase 2

• 1 other identifier: 87, 1, 2007_01_30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

novel antipsychotic; quetiapine; depression; psychopathology

Outcome Measures

Primary Outcomes (1)

• 1) blood alcohol concentration > 1.0 per mille 2) alcohol consumption > 40 g/day (females) or > 60 g/day (males) 3) continuous intake of alcohol during more than 5 consecutive days (independent of the amount of alcohol)

  7 month

Secondary Outcomes (1)

• first consumption of any ethanol,number of drinking and abstinence days,craving measured by the total score of the OCDS-G,STAI,PSQI,depression measured with MADRS and BDI,Amount of total daily cigarette consumption,FTND,CO-breath analysis variance

  7 month

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Seroquel®

2

NO INTERVENTION

Interventions

Seroquel® DRUG

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

Also known as: Quetiapine

1

Eligibility Criteria

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

You may qualify if:

• Alcohol dependence according to ICD-10 and DSM-IV since a minimum of 12 months.
• Detoxified male or female aged between 18 and 65 years.
• Abstinence for a minimum of 7 days and maximum of 21 days before randomization.
• Craving : minimum of 5 points at randomisation (OCDS-G)
• Free informed consent has been given in written form.
• Women of childbearing potential must use a medically accepted method of contraception.
• Only methods with a Pearl-index lower than 1% are regarded as acceptable such as hormonal contraception, surgical sterilization, bilateral ovarectomy, and postmenopause (WHO definition: natural menopause retrospectively for at least one year amenorrhoe) without hormonal replacement therapy within the past 5 months.

You may not qualify if:

• Patients suffering from psychotic diseases and/or depression with psychotic symptoms and/or demented patients, patients with longlasting continous treatment with psychotropic drugs.
• Known substance abuse other than alcohol or nicotine (except dependence in full remission) as defined by DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded only if they satisfy the DSM-IV criteria for abuse or dependence.
• Hepatitis (GGT or AST three times above normal range).
• An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter.
• A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
• unstable DM defined as enrollment glycosylated hemoglobin (HbA1c)\>8.5 %; patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks; patients not under physicians care for DM; physicians responsible for patient´s DM care has not indicated that patient´s DM is controlled; physician responsible for patient´s DM care has not approved patient´s participation in the study; patient has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to randomization. \[For thiazolidinediones (glitazones) this period should not be less than 8 weeks\]; patients taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
• Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
• Evidence of clinical relevant disease or clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by study medication or that would affect study medication.
• Patients who, in the investigator's judgment, pose a current serious suicidal risk or have made a suicide attempt within the past 6 months.
• Restricted or complete legal incapacity.
• Additional psychotherapy 1 month prior to randomisation or during participation in the study.
• History of idiopathic orthostatic hypotension, or condition that would predispose to hypotension (e.g. dehydration, hypovolemia).
• Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, C, via blood or other body fluids (as judged by the investigator). Positive HIV-serology in the screening visit.
• Known regular treatment with Quetiapine prior to randomisation.
• Hypersensitivity to Quetiapine or other constituents of the investigational product.

Sponsors & Collaborators

• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Goettingen

Göttingen, Lower Saxony, Germany

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Depression

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Karl Mann, MD PhD

  Dept. of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Mannheim, University of Heidelberg, Germany

  PRINCIPAL INVESTIGATOR

• Bernhard Croissant, MD PhD

  Dept. of Psychiatry and Psychotherapy, Hospital Sigmaringen, University of Tuebingen

  PRINCIPAL INVESTIGATOR

• Ursula Havemann-Reinecke, MD PhD

  Department of Psychiatry and Psychotherapy, Georg-August-University, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: April 18, 2011

Record last verified: 2008-01

Locations

DE (1)