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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cocaine use Depression Anxiety Addiction severity Retention Global improvement Psychopathology
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati MDRU
🇺🇸Cincinnati, Ohio, United States
Cincinnati MDRU🇺🇸Cincinnati, Ohio, United States