Naltrexone Maintenance Treatment of Alcoholism

Completed · Phase 4 · Has a placebo group

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID

NCT00000450

Run by

The Scripps Research Institute

People needed

159

Starts

1997-04-10

Expected to finish

2002-02-13

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Department of Psychiatry, University of Miami School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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