Phase 1, Double-blind, Placebo-controlled Assessment of Interactions Between 2 Doses of Cocaine and Three Doses of Escalating Vanoxerine (GBR 12909) in Cocaine Using Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Medication effects, including frequency of adverse events
研究概览
简要总结
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.
详细描述
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Dopamine transporters (DAT) play an important role in the addictive nature of cocaine; the use of compounds that target DAT may be effective in treating cocaine dependent individuals. Research shows that GBR 12909 has a strong affinity for DAT. The purpose of this study is to determine the safety and potential interaction of GBR 12909 and cocaine in cocaine dependent individuals.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets DSM-IV criteria for current cocaine dependence
- •Not currently seeking treatment for cocaine dependence
- •Currently uses cocaine, as determined by a self-report and a positive urine test for cocaine, within 30 days prior to study entry
- •Within 20 % of ideal body weight, and weighs at least 100 lbs
- •Good general health
- •Normal electrocardiogram
- •Willing to use acceptable methods of contraception for the duration of the study
排除标准
- •Current or history of a major psychiatric illness, other than drug dependence or disorders secondary to drug abuse
- •Meets DSM-IV criteria for dependence on any drugs other than cocaine, marijuana, nicotine, or alcohol
- •Physiologically dependent on alcohol and requires medical detoxification
- •Use of prescription drugs within 14 days prior to study entry
- •Use of non-prescription drugs within 7 days prior to study entry
- •If female, used an oral contraceptive, Depo-Provera, Norplant, or intrauterine progesterone contraceptive system, within 30 days prior to study entry
- •Pregnant or breastfeeding
- •History of liver disease
- •Current elevated aspartate aminotransferase or alanine aminotransferase levels
- •Donated a unit of blood within 4 weeks prior to study entry
- •Participated in any other clinical investigation within 4 weeks prior to study entry
- •History of any illness or behavior that, in the opinion of the investigator, might interfere with the study
- •Family history of early significant cardiovascular disease
- •Exhibits Hepatitis B surface antigen or Hepatitis C antibody
- •HIV infected
- •Active tuberculosis
- •Adult asthma
- •Chronic obstructive pulmonary disease
- •Unable to distinguish between 20 mg and 40 mg of intravenous cocaine
研究组 & 干预措施
1
50 mg of GBR 12909
干预措施: GBR 12909 (Drug)
2
75 mg of GBR 12909
干预措施: GBR 12909 (Drug)
3
100 mg of GBR 12909
干预措施: GBR 12909 (Drug)
结局指标
主要结局
Medication effects, including frequency of adverse events
时间窗: 12 days of trial
次要结局
未报告次要终点