Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

NCT00027079 | Completed Phase 2

• 1 other identifier: NIAAAJOH12964
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Interventions

ondansetron (Zofran) DRUG

naltrexone (ReVia) DRUG

Cognitive Behavioral Therapy BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ondansetron; Naltrexone; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 20, 2001
• First Posted: November 21, 2001
• Study Start: September 1, 2001
• Study Completion: August 1, 2004
• Last Updated: December 10, 2007

Record last verified: 2007-12

Locations

US (1)