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

NCT00678457 | Completed Phase 2 DMC

• 2 other identifiers: TO45228IRB-HSR #12816
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Dependence

Keywords

alcohol dependence; alcohol abuse; drinking; alcohol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Throughout the study

Study Arms (2)

ondansetron/olanzapine

EXPERIMENTAL

ondansetron (4 μg/kg b.i.d.) olanzapine (9 μg/kg)

Drug: Ondansetron; Drug: Olanzapine

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Ondansetron DRUG

ondansetron (4 μg/kg b.i.d.)

Also known as: Zofran

ondansetron/olanzapine

Olanzapine DRUG

olanzapine (9, 18, and 36 μg/kg)

Also known as: Zyprexa

ondansetron/olanzapine

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (2)

UVA CARE

Charlottesville, Virginia, 22911, United States

Location

UVA CARE Richmond

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ondansetron; Olanzapine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzodiazepines; Benzazepines

Study Officials

• Bankole Johnson, DSc, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 15, 2008
• Study Start: January 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

US (2)