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

Information source: University of Virginia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence

Intervention: Ondansetron (Drug); Olanzapine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Bankole Johnson, DSc, MD, PhD, Principal Investigator, Affiliation: University of Virginia

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.

Clinical Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Primary outcome: 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: The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

UVA CARE, Charlottesville, Virginia 22911, United States

UVA CARE Richmond, Richmond, Virginia 23294, United States

Additional Information

Starting date: January 2007
Ending date: May 2008
Last updated: May 29, 2008

Page last updated: June 20, 2008

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