Naltrexone Maintenance Treatment of Alcoholism

The Scripps Research Institute

Status and phase

Completed

Phase 4

Conditions

Alcoholism

Treatments

Drug: Matched Placebo Tablet

Drug: Naltrexone Tablet

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00000450

R01AA010518 (U.S. NIH Grant/Contract)

NIAAAMAS10518

Details and patient eligibility

About

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.

Enrollment

159 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.