Efficacy of Nefazodone in Cocaine Dependent Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Urine benzoylecgonine (BE) concentration
研究概览
简要总结
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nefazodone
Nefazodone 100 mg tablet, titrated to a maximum of 200 mg administered twice daily by treatment day 10. Drug tapered over 7 days at the conclusion of the treatment period. Treatment was administered for 8 weeks.
干预措施: Nefazodone (Drug)
Nefazodone
Nefazodone 100 mg tablet, titrated to a maximum of 200 mg administered twice daily by treatment day 10. Drug tapered over 7 days at the conclusion of the treatment period. Treatment was administered for 8 weeks.
干预措施: Psychosocial Treatment (Behavioral)
Matched Placebo Tablet
Matched placebo tablet, titrated up to 2 tablets twice daily by day 10 and tapered over 7 days at the conclusion of the study. Treatment period lasted 8 weeks.
干预措施: Nefazodone (Drug)
Matched Placebo Tablet
Matched placebo tablet, titrated up to 2 tablets twice daily by day 10 and tapered over 7 days at the conclusion of the study. Treatment period lasted 8 weeks.
干预措施: Psychosocial Treatment (Behavioral)
结局指标
主要结局
Urine benzoylecgonine (BE) concentration
时间窗: 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.
次要结局
- Alcohol Drug Use Inventory(Baseline through Study Week 8)
- Hamilton Depression Scale (HAM-D)(Baseline through Study Week 8)
- Cocaine-Craving Scale(Baseline through Week 8)
- Adverse Events Self Report(Study Weeks 1 through 8)
研究者
Dominic Ciraulo
Principal Investigator
Boston Medical Center