Naltrexone Maintenance Treatment of Alcoholism

April 18, 2017 updated by: Barbara J. Mason, The Scripps Research Institute

Nalmefene Maintenance Treatment of Alcoholism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Department of Psychiatry, University of Miami School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Naltrexone Tablet
Drug: Naltrexone Tablet
Other Names:
  • Revia
Placebo Comparator: Matched Placebo Tablet
Drug: Matched Placebo Tablet
Other Names:
  • Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Scripps Research Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Barbara Mason, Ph.D., The Scripps Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 1997

Primary Completion (Actual)

February 13, 2002

Study Completion (Actual)

February 13, 2002

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAMAS10518
  • R01AA010518 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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