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Combined Pharmacotherapies for Alcoholism (naltrexone/ondansetron) - Article


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Naltrexone

ReVia



Clinical Trial: Combined Pharmacotherapies for Alcoholism (naltrexone/ondansetron)

This study is currently recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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 Treatment or Intervention Phase
Alcoholism
 Drug: ondansetron (Zofran)
 Drug: naltrexone (ReVia)
 Behavior: Cognitive Behavioral Therapy
Phase II

MedlinePlus related topics:  Alcoholism

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Further Study Details: 

Expected Total Enrollment:  360

Study start: September 2001;  Expected completion: August 2005

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information


Texas
      University of Texas Health Science Center, San Antonio,  Texas,  78229,  United States; Recruiting
Dr. Bankole Johnson  210-567-2544 

More Information

Study ID Numbers:  NIAAAJOH12964
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  November 20, 2001
ClinicalTrials.gov Identifier:  NCT00027079
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: June 1, 2005
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