Naltrexone in Treatment of Cocaine Dependence - 5

Phase 2

Completed

• Conditions: Cocaine-Related Disorders

• Registration Number: NCT00015080
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Detailed Description

Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.

Study Timeline

• Study Start: 1995-05
• Primary Completion: 1996-06
• Study Completion: 1996-07
• Status Verified: 1996-12
• Study First Submitted QC: 2001-04-17
• Study First Submitted: 2001-04-18
• Study First Posted: 2001-04-18
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet DSM-III-R criteria for cocaine dependency,
2. 18 to 65 years of age,
3. capable of understanding the study,
4. voluntarily signed consent,
5. male or non-pregnant female using approved form of birth control.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retention
Global improvement
Psychopathology
Cocaine use
Depression
Anxiety
Addiction severity

Trial Locations

Locations (1)

Cincinnati MDRU; 🇺🇸 Cincinnati, Ohio, United States