Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Olanzapine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, alcohol abuse, drinking, alcohol
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
Sites / Locations
- UVA CARE
- UVA CARE Richmond
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ondansetron/olanzapine
placebo
Arm Description
ondansetron (4 μg/kg b.i.d.) olanzapine (9 μg/kg)
placebo
Outcomes
Primary Outcome Measures
The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics.
Secondary Outcome Measures
The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00678457
Brief Title
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
Official Title
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcohol dependence, alcohol abuse, drinking, alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ondansetron/olanzapine
Arm Type
Experimental
Arm Description
ondansetron (4 μg/kg b.i.d.)
olanzapine (9 μg/kg)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
ondansetron (4 μg/kg b.i.d.)
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
olanzapine (9, 18, and 36 μg/kg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA CARE
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
UVA CARE Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
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