Back to resultsNaltrexone in Treatment of Cocaine Dependence - 5
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria: Meet DSM-III-R criteria for cocaine dependency, 18 to 65 years of age, capable of understanding the study, voluntarily signed consent, male or non-pregnant female using approved form of birth control. Exclusion Criteria: 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
Sites / Locations
- Cincinnati MDRU
Outcomes
Primary Outcome Measures
Retention
Cocaine use
Depression
Anxiety
Addiction severity
Global improvement
Psychopathology
Secondary Outcome Measures
Full Information
NCT ID
NCT00015080
First Posted
April 18, 2001
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati MDRU
1. Study Identification
Unique Protocol Identification Number
NCT00015080
Brief Title
Naltrexone in Treatment of Cocaine Dependence - 5
Official Title
Naltrexone in Treatment of Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
December 1996
Overall Recruitment Status
Completed
Study Start Date
May 1995 (undefined)
Primary Completion Date
June 1996 (Actual)
Study Completion Date
July 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati MDRU
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Primary Outcome Measure Information:
Title
Retention
Title
Cocaine use
Title
Depression
Title
Anxiety
Title
Addiction severity
Title
Global improvement
Title
Psychopathology
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet DSM-III-R criteria for cocaine dependency,
18 to 65 years of age,
capable of understanding the study,
voluntarily signed consent,
male or non-pregnant female using approved form of birth control.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Somoza, M.D., Ph.D.
Organizational Affiliation
Cincinnati MDRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati MDRU
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
background
Learn more about this trial
Naltrexone in Treatment of Cocaine Dependence - 5
We'll reach out to this number within 24 hrs