Expired Study
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San Antonio, Texas 78229


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.


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.


Study is Available At:


Original ID:

NIAAAJOH12964


NCT ID:

NCT00027079


Secondary ID:


Study Acronym:


Brief Title:

Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)


Official Title:


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Double-Blind, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

360


Enrollment Type:


Study Dates

Start Date:September 2001
Completion Date:August 2004
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 7, 2007
First Received Date:November 20, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:ondansetron (Zofran)
Intervention Type:Drug
Name:naltrexone (ReVia)
Intervention Type:Behavioral
Name:Cognitive Behavioral Therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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