Cocaine-Related Disorders, Substance-Related Disorders
Conditions
Keywords
Cocaine Use Disorders Dependence Depression
Brief summary
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
Detailed description
The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.
Interventions
DRUGNefazodone
BEHAVIORALPsychosocial Treatment
All subjects attended a weekly 1-hour therapy session during the 8 week treatment period.
Sponsors
Boston University
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.
Exclusion criteria
Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history. Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine benzoylecgonine (BE) concentration | Study Weeks Basekine to Week 8 | Natural log BE in urine samples collected weekly were analyzed for the baseline week and the subsequent 8 treatment weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | Baseline through Study Week 8 | HAM-D collected on a weekly basis. |
| Cocaine-Craving Scale | Baseline through Week 8 | CCS scores were collected on a weekly basis. |
| Adverse Events Self Report | Study Weeks 1 through 8 | Data for adverse events were collected on a weekly basis |
| Alcohol Drug Use Inventory | Baseline through Study Week 8 | Subjects were asked about the amount of cocaine consumed and the number of days in cocaine was used in the previous week, on a weekly basis. |
Countries
United States
Outcome results
None listed