Completed

Nalmefene Maintenance Treatment of Alcoholism

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Naltrexone Tablet

+ Matched Placebo Tablet

Drug
Who is being recruted

Alcoholism+2

+ Mental Disorders

+ Substance-Related Disorders

From 18 to 65 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorThe Scripps Research Institute
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 10, 1997

Actual date on which the first participant was enrolled.

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.

Official TitleNalmefene Maintenance Treatment of Alcoholism
NCT00000450
Principal SponsorThe Scripps Research Institute
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

159 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlcoholismMental DisordersSubstance-Related DisordersAlcohol-Related DisordersChemically-Induced Disorders

Criteria

2 inclusion criteria required to participate
Meets criteria for alcohol dependence.
Expresses a desire to cut down or stop drinking.
13 exclusion criteria prevent from participating
More than 6 weeks of abstinence.
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Psychiatry, University of Miami School of Medicine

Miami, United StatesOpen Department of Psychiatry, University of Miami School of Medicine in Google Maps
CompletedOne Study Center