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Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00027079
Recruitment Status : Completed
First Posted : November 21, 2001
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Tracking Information
First Submitted Date  ICMJE November 20, 2001
First Posted Date  ICMJE November 21, 2001
Last Update Posted Date December 10, 2007
Study Start Date  ICMJE September 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • Drug: ondansetron (Zofran)
  • Drug: naltrexone (ReVia)
  • Behavioral: Cognitive Behavioral Therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
360
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00027079
Other Study ID Numbers  ICMJE NIAAAJOH12964
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP