Post-Treatment Effects of Naltrexone

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.

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Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Psychiatric Research, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

naltrexone (Revia)

Drug

broad spectrum treatment

Behavioral

Motivational Enhancement Therapy

Behavioral

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start: 2000
Study completion: 2006
First posted: Nov 7, 2000
Registry last updated: May 12, 2010

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.

Published trials that share one or more normalized conditions with this study.

Completed