Naltrexone in Treatment of Cocaine Dependence - 5

Cocaine-Related Disorders Clinical Trial

Official title:

Naltrexone in Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00015080
• Other study ID #: NIDA-5-0012-5
• Secondary ID: Y01-5-0012-5
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2001
• Last updated: January 13, 2017
• Start date: May 1995
• Est. completion date: July 1996

Study information

• Verified date: December 1996
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1996
• Est. primary completion date: June 1996
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• Naltrexone

Locations

Country	Name	City	State
United States	Cincinnati MDRU	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Cincinnati MDRU

Country where clinical trial is conducted

United States, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention
Primary	Cocaine use
Primary	Depression
Primary	Anxiety
Primary	Addiction severity
Primary	Global improvement
Primary	Psychopathology