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OpenTrials
Completed

NCT Number: NCT00027079

Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron (Zofran)

Drug

naltrexone (Revia)

Drug

Cognitive behavioral therapy

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Nih

Registry information

Important dates

Study start
2001
Study completion
2004
First posted
Nov 21, 2001
Registry last updated
Dec 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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