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Naltrexone Maintenance Treatment of Alcoholism

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naltrexone Tablet
Matched Placebo Tablet
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Psychiatry, University of Miami School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Naltrexone Tablet

Matched Placebo Tablet

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 18, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000450
Brief Title
Naltrexone Maintenance Treatment of Alcoholism
Official Title
Nalmefene Maintenance Treatment of Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 10, 1997 (Actual)
Primary Completion Date
February 13, 2002 (Actual)
Study Completion Date
February 13, 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Naltrexone and placebo were identical in appearance and packaging to preserve the double blind.
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone Tablet
Arm Type
Active Comparator
Arm Title
Matched Placebo Tablet
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone Tablet
Other Intervention Name(s)
Revia
Intervention Type
Drug
Intervention Name(s)
Matched Placebo Tablet
Other Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Naltrexone Maintenance Treatment of Alcoholism

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