NCT00000445

Brief Summary

This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at 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
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2003

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Alcoholism

Interventions

naltrexone (Revia)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for alcohol dependence (within the past 3 months).
  • Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse.
  • Must be able to provide an informed consent.
  • Consent to random assignment and be willing to commit to possible medication treatment and research follow-up.
  • Must be eligible for treatment at the Dorchester Alcohol and Drug Commission.

You may not qualify if:

  • Meets criteria for opiate dependence.
  • Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion.
  • Hepatocellular disease.
  • Women who are pregnant, nursing, or not practicing an effective means of birth control.
  • Currently being prescribed naltrexone.
  • Known sensitivity or allergy to naltrexone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Drug and Alcohol Programs, Medical University of South Carolina

Charleston, South Carolina, 29425, 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
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

September 1, 2002

Last Updated

June 24, 2005

Record last verified: 2003-07

Locations

US(1)