Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

This study has been completed.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier:
First received: November 20, 2001
Last updated: December 7, 2007
Last verified: December 2007
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
Drug: ondansetron (Zofran)
Drug: naltrexone (ReVia)
Behavioral: Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

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
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Please refer to this study by its identifier: NCT00027079

United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information Identifier: NCT00027079     History of Changes
Other Study ID Numbers: NIAAAJOH12964 
Study First Received: November 20, 2001
Last Updated: December 7, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Anti-Anxiety Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Antagonists
Tranquilizing Agents processed this record on May 26, 2016