Dopamine Transporter (DAT) in Pharmacological Treatments of Cocaine Dependence. CAIMAN (Cocaine Addiction Imaging Medications and Neurotransmitters) Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.
研究概览
简要总结
-Context: Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.
Primary Hypothesis:
More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during cocaine detoxification.
详细描述
Context:
Cocaine dependence is a disorder with a rapidly progressive evolution, associated with various complications. Because of cocaine's direct action on the dopamine transporter (DAT), dopaminergic system dysregulation plays a fundamental role in reinforcement phenomenon and in dependence. This has been proven in numerous animal and post-death human studies of striatal DAT. In vivo studies in cocaine dependent patients are rare. Currently no pharmacotherapy is available to treat this pathology. Current studies indicate that pharmacological agents such as modafinil may be able to reverse the neuroadaptations induced by cocaine dependence. However, no functional neuroimaging study (Positron Emission Tomography, PET) has analysed the impact of medications on DAT density in cocaine dependent patients. However, in primates, in vivo PET has shown modafinil affinity for DAT.
Primary Hypothesis:
More rapid normalisation of DAT concentrations measured by PET using modafinil versus placebo from D3 to D21 during therapeutic cocaine withdrawal.
Study objectives Primary: impact of modafinil versus placebo on DAT density modifications in the striatal and extra-striatal regions in cocaine dependent subjects hospitalised from D3 to D21.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men of at least 18 years of age
- •Cocaine dependent according to DSM IV TR criteria
- •Seeking treatment
- •Capable of understanding and giving their informed written consent
- •With National Health coverage
- •Urinary screen positive for cocaine in the weeks prior to inclusion
排除标准
- •Other DSM IV TR axe I diagnostic criteria (except for tobacco)
- •Neurological disorders
- •Treatment that interferes with the DAT and modafinil
- •Contraindications for modafinil and Magnetic Resonance Imaging
研究组 & 干预措施
1
active
干预措施: Modafinil and PET (brain imaging) (Drug)
2
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Decreased DAT occupation rates in the modafinil group versus placebo from day 3 to day of cocaine detoxification.
时间窗: day 3 and day of cocaine detoxification
次要结局
- Evaluation of the clinical efficacy of modafinil during therapeutic cocaine withdrawal.(D3 to D90)
- Correlation between craving measurements, depressive symptom measurements and cognitive deficit measurements observed and modifications of DAT density.(D3 to D21)
- Study of DAT from D3 to D21 versus a pre-existing data base of control subjects.(D3 to D21)
- Tolerance and safety evaluation of high modafinil doses, measured by adverse events and biological parameters.(D3 to D90)