Post-Treatment Effects of Naltrexone

Alcoholism Clinical Trial

Official title:

Post-Treatment Effects of Naltrexone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006449
• Other study ID #: NIAAADAV12696
• Secondary ID: R01AA012696
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2000
• Last updated: May 11, 2010
• Start date: September 2000
• Est. completion date: July 2006

Study information

• Verified date: May 2010
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment

• Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.

• Must be fluent in English.

• Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

• Severe hepatic disease or a liver function test greater than 4 times normal.

• Opiate use in the last 14 days or a history of opioid dependence in the past year.

• Pregnant or lactating females who are not using a reliable method of birth control.

• Inability to follow medication instructions and safety precautions.

• Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana dependence.

• Use of medications intended to decrease drinking.

• Meets criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Behavioral:
• broad spectrum treatment

• motivational enhancement therapy

Locations

Country	Name	City	State
United States	Institute of Psychiatric Research, Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,