Cocaine-Related Disorders
Conditions
Keywords
cocaine dependence
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.
Interventions
DRUGNaltrexone
Sponsors
Cincinnati MDRU
National Institute on Drug Abuse (NIDA)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention | — |
| Cocaine use | — |
| Depression | — |
| Anxiety | — |
| Addiction severity | — |
| Global improvement | — |
| Psychopathology | — |
Countries
United States
Outcome results
None listed