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Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
This study has been completed.
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00027079
  Purpose

This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.


Condition Intervention Phase
Alcoholism
Drug: ondansetron (Zofran)
Drug: naltrexone (ReVia)
Behavioral: Cognitive Behavioral Therapy
Phase II

MedlinePlus related topics: Alcoholism
Drug Information available for: Naltrexone Ondansetron Ondansetron hydrochloride Naltrexone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

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

Estimated Enrollment: 360
Study Start Date: September 2001
Study Completion Date: August 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of alcohol dependence.
  • Provide a written informed consent.
  • Must weigh within 30% of their ideal body weight.
  • Patients must weigh at least 89 lbs. and no more than 342 lbs.
  • Good physical health.
  • Currently drinking 14 or more alcohol units per week for women and 21 or more alcohol units per week for men in the last 30 days.
  • Provide evidence of stable residence in the last month prior to enrollment in the study.
  • No plans to move in the nine months after entering the study.
  • Literate in English and able to read, understand, and complete questionnaires and follow instructions.
  • Willingness to participate in behavioral treatment for alcoholism.

Exclusion Criteria:

  • Current psychiatric disorder other than alcohol or nicotine dependence.
  • Elevated liver enzymes or elevated bilirubin.
  • Severe alcohol withdrawal symptoms which require treatment.
  • Serious medical co-morbidity requiring medical intervention or close supervision.
  • Severe or life-threatening adverse reactions to medications in the past or during this 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.
  • Compelled to participate in an alcohol treatment program for alcohol dependence to maintain their liberty.
  • Members of the same household.
  • Tuberculosis.
  • Current treatment with any medications having a potential effect on alcohol consumption and related behaviors or mood.
  • Urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
  • Pyrexia of unknown origin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027079

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
  More Information

Study ID Numbers: NIAAAJOH12964
Study First Received: November 20, 2001
Last Updated: December 7, 2007
ClinicalTrials.gov Identifier: NCT00027079  
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Sensory System 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