NCT00000442

Brief Summary

This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 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
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

June 20, 2011

Status Verified

June 1, 2011

First QC Date

November 2, 1999

Last Update Submit

June 17, 2011

Conditions

Alcoholism

Interventions

naltrexone (Revia)DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets criteria for alcohol dependence.
  • Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
  • Able to read English and complete study evaluations.
  • Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.

You may not qualify if:

  • Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
  • Prior history of opioid dependence.
  • Regular use of psychoactive drugs including anxiolytics and antidepressants.
  • Prior treatment with naltrexone.
  • Current use of disulfiram.
  • Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).
  • Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.
  • Abstinent longer than 28 days prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Pennsylvania

Philadelphia, Pennsylvania, 19103, 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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

December 1, 2002

Last Updated

June 20, 2011

Record last verified: 2011-06

Locations

US(1)