Nalmefene Maintenance Treatment of Alcoholism

The Scripps Research Institute1 site in 1 country159 target enrollmentApril 10, 1997

ConditionsAlcoholism

InterventionsNaltrexone Tablet Matched Placebo Tablet

DrugsNaltrexone Tablet Matched Placebo Tablet

Overview

Phase: Phase 4
Intervention: Naltrexone Tablet
Conditions: Alcoholism
Sponsor: The Scripps Research Institute
Enrollment: 159
Locations: 1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 10, 1997

End Date

February 13, 2002

Last Updated

9 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

The Scripps Research Institute

Responsible Party

Principal Investigator

Barbara J. Mason

Principal Investigator

The Scripps Research Institute

Eligibility 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.