Naltrexone Maintenance Treatment of Alcoholism

Study Overview
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Brief Summary
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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.

Official Title
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Nalmefene Maintenance Treatment of Alcoholism

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Naltrexone Tablet
* Drug: Matched Placebo Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Naltrexone 50 mg was provided for 3 months to all study participants, who were masked regarding the identity of study medication. At 3 months, full and partial responders were randomized to an additional 9 months of double blind treatment with naltrexone or matched placebo. Full responders were defined as complete abstinence for the last six weeks of the acute phase. Partial responders were defined as having no more than 2 heavy drinking days in any given week and/or a 50% reduction in weekly alcohol consumption from baseline over the last six weeks of the acute phase.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naltrexone Tablet<br> | Drug: Naltrexone Tablet<br> <br> * Other names: Revia;|
| Placebo Comparator: Matched Placebo Tablet<br> | Drug: Matched Placebo Tablet<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |