Naltrexone Maintenance Treatment of Alcoholism

Alcoholism Clinical Trial

Official title:

Nalmefene Maintenance Treatment of Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000450
• Other study ID #: NIAAAMAS10518
• Secondary ID: R01AA010518
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: April 18, 2017
• Start date: April 10, 1997
• Est. completion date: February 13, 2002

Study information

• Verified date: April 2017
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 13, 2002
• Est. primary completion date: February 13, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Naltrexone Tablet

• Matched Placebo Tablet

Locations

Country	Name	City	State
United States	Department of Psychiatry, University of Miami School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,