Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
Phase 2
Completed
- Conditions
- Alcohol Dependence
- Interventions
- Registration Number
- NCT00678457
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description placebo Placebo placebo ondansetron/olanzapine Ondansetron ondansetron (4 μg/kg b.i.d.) olanzapine (9 μg/kg) ondansetron/olanzapine Olanzapine ondansetron (4 μg/kg b.i.d.) olanzapine (9 μg/kg)
- Primary Outcome Measures
Name Time Method The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics. Throughout the study
- Secondary Outcome Measures
Name Time Method The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking. Throughout the study
Trial Locations
- Locations (2)
UVA CARE
🇺🇸Charlottesville, Virginia, United States
UVA CARE Richmond
🇺🇸Richmond, Virginia, United States