Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 11
- 主要终点
- Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.
研究概览
简要总结
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.
详细描述
Cocaine addiction, a serious public health concern associated with significant medical, social, and economic consequences, is difficult to treat using traditional psychosocial and behavioral therapies. Despite testing of a number of different agents for cocaine dependency, there remains no proven pharmacologic treatment for cocaine addiction.
The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system (CNS). Cocaine administration increases the levels of dopamine, a neurotransmitter associated with sensations of pleasure and reward. Therefore, blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction.
Another neurotransmitter, gamma-aminobutyric acid (GABA), suppresses striatal dopamine release, and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence. Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward. Thus, drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study and provide written informed consent.
- •Male or female at least 18 years of age.
- •Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
- •Provide at least one urine sample that is positive for cocaine according to a rapid screening test.
- •Seeking treatment for cocaine dependence.
- •Have normal visual fields.
- •Be in generally good health based on history, physical examination, electrocardiogram and laboratory findings.
- •If female of childbearing potential, use acceptable contraceptive methods. (oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable
排除标准
- •Has current dependence, as determined by the SCID, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiologic dependence on alcohol requiring medical detoxification.
- •Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk.
- •Be under court mandate to obtain treatment.
- •Be enrolled in an opiate substitution treatment program within 2 months of randomization.
- •Has ever taken vigabatrin in the past.
- •Is pregnant or lactating.
- •Has clinically significant ophthalmologic disease, which would preclude safety monitoring or is undergoing treatment for ocular disease.
- •Has received a drug with known major organ toxicity, including retinotoxicity within 30 days of randomization.
- •Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
- •Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol, due to imminent relocation from the clinic area, legal difficulties, work-related problems, transportation, etc.
研究组 & 干预措施
1
3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks
干预措施: vigabatrin (Drug)
2
3 Placebo Tablets, bid, for 9 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.
时间窗: Week 13
Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.
次要结局
未报告次要终点