Naltrexone Maintenance Treatment of Alcoholism

Phase 4

Completed

• Conditions: Alcoholism
• Interventions: Drug: Naltrexone Tablet; Drug: Matched Placebo Tablet

• Registration Number: NCT00000450
• Lead Sponsor: The Scripps Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-04-10
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Primary Completion: 2002-02-13
• Study Completion: 2002-02-13
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Naltrexone Tablet	Naltrexone Tablet	-
Matched Placebo Tablet	Matched Placebo Tablet	-

Trial Locations

Locations (1)

Department of Psychiatry, University of Miami School of Medicine; 🇺🇸 Miami, Florida, United States