NCT00000307

Brief Summary

The purpose of this study is to evaluate naltrexone as an adjunct in alcoholic cocaine dependent patients; concurrent relapse prevention theory.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2003

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
3.5 years until next milestone

Study Start

First participant enrolled

April 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Alcohol-Related DisordersCocaine-Related Disorders

Keywords

alcohol dependence

Outcome Measures

Primary Outcomes (1)

  • Verified abstinence from cocaine

    over the 12 weeks of study

Interventions

NaltrexoneDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77225, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersCocaine-Related DisordersAlcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Substance-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 Officials

  • John Grabowski, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

April 1, 2003

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)