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

NCT ID: NCT00678457

Last Updated: 2009-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-05-31

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.

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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; alcohol abuse; drinking; alcohol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ondansetron/olanzapine

ondansetron (4 μg/kg b.i.d.)

olanzapine (9 μg/kg)

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

ondansetron (4 μg/kg b.i.d.)

Olanzapine

Intervention Type: DRUG

olanzapine (9, 18, and 36 μg/kg)

placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

Ondansetron

ondansetron (4 μg/kg b.i.d.)

Intervention Type: DRUG

Olanzapine

olanzapine (9, 18, and 36 μg/kg)

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Zofran; Zyprexa

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia

Principal Investigators

Bankole Johnson, DSc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

UVA CARE

Charlottesville, Virginia, United States

UVA CARE Richmond

Richmond, Virginia, United States

Countries

United States

Other Identifiers

IRB-HSR #12816

Identifier Type: -

Identifier Source: secondary_id

TO45228

Identifier Type: -

Identifier Source: org_study_id