NCT00000438

Brief Summary

This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

May 14, 2010

Status Verified

May 1, 2010

First QC Date

November 2, 1999

Last Update Submit

May 13, 2010

Conditions

Alcoholism

Interventions

naltrexone (Revia)DRUG

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets criteria for alcohol dependence.
  • Committed to alcohol abstinence as a treatment goal.
  • Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.

You may not qualify if:

  • Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
  • Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
  • Females who are pregnant, lactating, or not using a reliable method of contraception.
  • Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
  • Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
  • Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
  • Vocabulary below the 5th grade reading level.
  • Abnormal MRI scan.
  • HIV infection due to the neurological sequelae.
  • Significant central nervous system diseases.
  • Seizure disorder or history of closed head trauma.
  • Neuroendocrine disorders.
  • Treatment with opiates within the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

March 1, 2003

Last Updated

May 14, 2010

Record last verified: 2010-05

Locations

US(1)