Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
This study has been completed.
Sponsored by: University of Virginia
Information provided by: University of Virginia
ClinicalTrials.gov Identifier: NCT00678457
  Purpose

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 Intervention Phase
Alcohol Dependence
Drug: Ondansetron
Drug: Olanzapine
Drug: Placebo
Phase II

MedlinePlus related topics: Alcoholism
Drug Information available for: Olanzapine Ondansetron Ondansetron hydrochloride Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

Further study details as provided by University of Virginia:

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. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ondansetron/olanzapine: Experimental

ondansetron (4 μg/kg b.i.d.)

olanzapine (9 μg/kg)

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678457

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

Responsible Party: University of Virginia ( Bankole Johnson, DSc, M.D., Ph.D. )
Study ID Numbers: TO45228, IRB-HSR #12816
Study First Received: May 8, 2008
Last Updated: May 29, 2008
ClinicalTrials.gov Identifier: NCT00678457  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
alcohol dependence
alcohol abuse
drinking
alcohol

Study placed in the following topic categories:
Mental Disorders
Alcoholism
Olanzapine
Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Ondansetron
Serotonin
Ethanol

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009