Naltrexone Maintenance Treatment of Alcoholism

• Status: Completed
• Trial end date: 2002-02-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.