Naltrexone Maintenance Treatment of Alcoholism

NCT00000450 | Completed Phase 4 FDA Drug

• 2 other identifiers: NIAAAMAS10518R01AA010518
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Study Arms (2)

Naltrexone Tablet

ACTIVE COMPARATOR

Drug: Naltrexone Tablet

Matched Placebo Tablet

PLACEBO COMPARATOR

Drug: Matched Placebo Tablet

Interventions

Naltrexone Tablet DRUG

Also known as: Revia

Naltrexone Tablet

Matched Placebo Tablet DRUG

Also known as: Placebo

Matched Placebo Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets criteria for alcohol dependence.
• Expresses a desire to cut down or stop drinking.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Department of Psychiatry, University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Barbara Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Naltrexone and placebo were identical in appearance and packaging to preserve the double blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: November 3, 1999
• Study Start: April 10, 1997
• Primary Completion: February 13, 2002
• Study Completion: February 13, 2002
• Last Updated: April 20, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)