Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Ondansetron hydrochloride Ondansetron Olanzapine

U.S. FDA Resources

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

No publications provided

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:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00678457 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Virginia:

alcohol dependence
alcohol abuse
drinking
alcohol

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Disorders of Environmental Origin
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Antipruritics
Alcohol-Related Disorders

Ondansetron
Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Alcoholism
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010