Naltrexone Maintenance Treatment of Alcoholism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-10

Study Completion Date

2002-02-13

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.

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Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Naltrexone and placebo were identical in appearance and packaging to preserve the double blind.

Study Groups

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Naltrexone Tablet

Group Type ACTIVE_COMPARATOR

Naltrexone Tablet

Intervention Type DRUG

Matched Placebo Tablet

Group Type PLACEBO_COMPARATOR

Matched Placebo Tablet

Intervention Type DRUG

Interventions

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Naltrexone Tablet

Intervention Type DRUG

Matched Placebo Tablet

Intervention Type DRUG

Other Intervention Names

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Revia Placebo

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No