Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00678457
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : January 30, 2009
Information provided by:
University of Virginia

Brief Summary:
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Ondansetron Drug: Olanzapine Drug: Placebo Phase 2

Detailed Description:

Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.

This is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
Study Start Date : January 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ondansetron/olanzapine

ondansetron (4 μg/kg b.i.d.)

olanzapine (9 μg/kg)

Drug: Ondansetron
ondansetron (4 μg/kg b.i.d.)
Other Name: Zofran
Drug: Olanzapine
olanzapine (9, 18, and 36 μg/kg)
Other Name: Zyprexa
Placebo Comparator: placebo
Drug: Placebo

Primary Outcome Measures :
  1. The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics. [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking. [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females who have given written informed consent
  • Aged 18 years and above and weighing ≥40 kg and ≤140 kg
  • Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment
  • DSM-IV-R diagnosis of alcohol dependence
  • Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range
  • Negative pregnancy test at intake.
  • Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
  • Willing to participate in behavioral treatments for alcoholism
  • Answer an advertisement in the newspaper/radio/television, and express a wish to stop drinking
  • Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months

Exclusion Criteria:

  • Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol
  • Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment
  • Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine
  • Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial
  • Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study
  • Received inpatient or outpatient treatment for alcohol dependence within the last 30 days
  • Significant medical illness (including hypertension) as determined by history and/or complete physical examination.
  • Gross neurological disease
  • Mental retardation
  • Pyrexia of unknown origin
  • Diagnosis or suspicion of Alzheimer's disease
  • Clinically significant abnormalities on the EKG that will preclude safe participation
  • Recent (last 3 months) history of ischemic heart disease or myocardial infarction.
  • Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.
  • Participation in a clinical study within the last 30 days
  • Elevation of liver enzymes
  • History of any severe or life-threatening reaction to olanzapine or ondansetron
  • Past or current history of seizures disorder
  • Past or current history of diabetes
  • Being treated with any medication with potential for clinically significant interactions with alcohol or olanzapine and/or ondansetron. These include:, serotonin antagonists (e.g., ritanserin or buspirone), dopamine antagonists (e.g., haloperidol), or compounds with actions similar to disulfiram (Antabuse®).
  • Pending imprisonment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00678457

United States, Virginia
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
University of Virginia
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia

Responsible Party: Bankole Johnson, DSc, M.D., Ph.D., University of Virginia Identifier: NCT00678457     History of Changes
Other Study ID Numbers: TO45228
IRB-HSR #12816
First Posted: May 15, 2008    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by University of Virginia:
alcohol dependence
alcohol abuse

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators