NCT00015080

Brief Summary

The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1995

Shorter than P25 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

Study Start

First participant enrolled

May 1, 1995

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1996

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1996

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
Last Updated

January 16, 2017

Status Verified

December 1, 1996

Enrollment Period

1.1 years

First QC Date

April 18, 2001

Last Update Submit

January 13, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (7)

  • Retention

  • Cocaine use

  • Depression

  • Anxiety

  • Addiction severity

  • Global improvement

  • Psychopathology

Interventions

NaltrexoneDRUG

Eligibility Criteria

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

You may qualify if:

  • Meet DSM-III-R criteria for cocaine dependency,
  • to 65 years of age,
  • capable of understanding the study,
  • voluntarily signed consent,
  • male or non-pregnant female using approved form of birth control.

You may not qualify if:

  • abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values),
  • opioid use within the last 7 days,
  • use of neuroleptics,
  • having a severe acute medical problem,
  • unable to complete psychiatric rating scales, or
  • judged by the investigator to be unlikely to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • Somoza, E., et al. A Double-Blind,Placebo Controlled Clinical Trial of Naltrexone as a Treatment for Cocaine Dependence. NIDA Research Monograph, 1998, 179, p. 295.. None

    BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders

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

  • Eugene Somoza, M.D., Ph.D.

    Cincinnati MDRU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

May 1, 1995

Primary Completion

June 1, 1996

Study Completion

July 1, 1996

Last Updated

January 16, 2017

Record last verified: 1996-12

Locations

US(1)