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Pharmacological Treatment for Alcoholism
This study is ongoing, but not recruiting participants.
First Received: September 28, 2006   Last Updated: October 14, 2008   History of Changes
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00382642
  Purpose

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 Behavioral Therapy will assist researchers to determine whether having a certain gene is responsible for determining how a person benefits or does not benefit from the use of ondansetron for alcohol dependence.


Condition Intervention Phase
Alcohol Dependence
Drug: Ondansetron
Behavioral: Group behavioral therapy
Phase III

MedlinePlus related topics: Alcoholism
Drug Information available for: Ondansetron hydrochloride Ondansetron
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Pharmacological Treatment for Alcoholism

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Self-reported measure of alcohol consumption (Drinks per Day, Drinks per Drinking Day, Percent Days Abstinent) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: June 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Arm 1 = Ondansetron + group behavioral therapy
Drug: Ondansetron
13 week outpatient trial
2: Placebo Comparator
Arm 2 = Placebo + group behavioral therapy
Behavioral: Group behavioral therapy
13 week outpatient trial

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 study is initially done over the telephone and takes 15-20 minutes. If participants are eligible after the initial screen, they will be invited to come in for a more thorough in house screen which takes about 5 to 6 hours. The screening will include a physical exam, review of medical, alcohol and drug histories and blood collection. If participants are found to be eligible after the in house screen, they will be enrolled in the 13 week outpatient clinical trial.

  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.
  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382642

Locations
United States, Virginia
UVA Center for Addiction Research and Education
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Investigators
Principal Investigator: Bankole Johnson, M.D., Ph.D. University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: University of Virginia Center for Addiction Research and Education ( Bankole Johnson, M.D., Study Principal Investigator )
Study ID Numbers: R01AA10522-11
Study First Received: September 28, 2006
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00382642     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
alcoholism, alcohol disorder, drinking,alcohol

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Antiemetics
Antipsychotic Agents
Serotonin
Mental Disorders
Alcoholism
Substance-Related Disorders
Antipruritics
Anti-Anxiety Agents
Alcohol-Related Disorders
Ondansetron
Peripheral Nervous System Agents
Ethanol

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
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
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Alcoholism
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009