Status:
COMPLETED
Pharmacological Treatment for Alcoholism
Lead Sponsor:
Bankole Johnson
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to learn whether ondansetron is safe and effective in the treatment of alcohol dependence. We also want to learn whether the study drug ondansetron combined with Cognitive...
Detailed Description
This is a 13 week outpatient clinical trial. Participants will either receive ondansetron or placebo and behavioral therapy. There is a 1, 2, and 3 month post-study follow up visit.Screening for this ...
Eligibility Criteria
Inclusion
- Males and females who have given written informed consent.
- Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
- Audit score equal or more than 8
- Current DSM-IV diagnosis of alcohol dependence
- Currently drinking equal or more than 14 alcohol units/week for women and equal or more than 21 alcohol units/week for men in the last 30 days.
- 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.
- The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
- Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
- Answer an advertisement in the newspaper/radio/television, and express a wish to stop drinking.
- Willingness to participate in behavioral treatments for alcoholism.
Exclusion
- Subjects who are legally mandated to participate in an alcohol treatment program.
- Any current axis I DSM IV psychiatric disorder other than alcohol or nicotine dependence
- Elevation of liver enzymes - (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the normal range, or clinically significant elevated direct bilirubin as deemed by the principal investigator.
- Severe alcohol withdrawal symptoms which in the physicians opinion requires inpatient treatment.
- Serious medical co-morbidity requiring medical intervention or close supervision, or any condition, which can interfere with the receipt of ondansetron.
- Severe or life-threatening adverse reactions to ondansetron or similar medication either in the past or during this clinical trial.
- Female patients 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 (support groups such as AA are not exclusionary).
- Compelled to participate in an alcohol treatment program to maintain their liberty.
- Members of the same household.
- Treated with any medications having a potential effect on alcohol consumption and related behaviors, or mood. These include: opiate antagonist (e.g. naltrexone), glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g. fluoxetine), serotonin antagonists (e.g. ritanserin or buspirone), other antidepressants (e.g. tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g. haloperidol), calcium channel antagonists (e.g. isradipine), or compounds with actions similar to disulfiram (antabuse) or nicotine.
- Before double-blind randomization, urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00382642
Start Date
June 1 2006
End Date
December 1 2009
Last Update
February 7 2012
Active Locations (1)
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1
UVA Center for Addiction Research and Education
Charlottesville, Virginia, United States, 22911