Naltrexone Maintenance Treatment of Alcoholism

The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, University of Miami School of Medicine

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Meets criteria for alcohol dependence.
Expresses a desire to cut down or stop drinking.

Exclusion criteria

Currently meets criteria for dependence on substances other than alcohol.
History of opiate dependence or evidence of current opiate use.
Significant medical disorders that will increase potential risk or interfere with study participation.
Liver function tests more than 3 times normal or elevated bilirubin.
Female patients who are pregnant, nursing, or not using a reliable method of birth control.
Inability to understand and provide a consent form.
Treatment with an investigational drug during the previous month.
Prior treatment with naltrexone.
Chronic treatment with any narcotic-containing medications during the previous month.
Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
Current treatment with disulfiram.
More than 6 weeks of abstinence.
Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.

Treatment and study plan

Naltrexone tablet

Drug

Other names: Revia

matched placebo tablet

Drug

Other names: Placebo

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Nalmefene Maintenance Treatment of Alcoholism

Important dates

Study start: 1997
Primary completion: 2002
Study completion: 2002
First posted: Nov 3, 1999
Registry last updated: Apr 20, 2017

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