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Naltrexone Maintenance Treatment of Alcoholism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000450
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Naltrexone Tablet Drug: Matched Placebo Tablet Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Naltrexone 50 mg was provided for 3 months to all study participants, who were masked regarding the identity of study medication. At 3 months, full and partial responders were randomized to an additional 9 months of double blind treatment with naltrexone or matched placebo. Full responders were defined as complete abstinence for the last six weeks of the acute phase. Partial responders were defined as having no more than 2 heavy drinking days in any given week and/or a 50% reduction in weekly alcohol consumption from baseline over the last six weeks of the acute phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Naltrexone and placebo were identical in appearance and packaging to preserve the double blind.
Primary Purpose: Treatment
Official Title: Nalmefene Maintenance Treatment of Alcoholism
Actual Study Start Date : April 10, 1997
Primary Completion Date : February 13, 2002
Study Completion Date : February 13, 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Naltrexone Tablet Drug: Naltrexone Tablet
Other Name: Revia
Placebo Comparator: Matched Placebo Tablet Drug: Matched Placebo Tablet
Other Name: Placebo


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000450


Locations
United States, Florida
Department of Psychiatry, University of Miami School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Barbara Mason, Ph.D. The Scripps Research Institute
More Information

Responsible Party: Barbara J. Mason, Principal Investigator, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00000450     History of Changes
Other Study ID Numbers: NIAAAMAS10518
R01AA010518 ( U.S. NIH Grant/Contract )
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents