NCT00385801已完成2 期
A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
研究概览
简要总结
The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •current cocaine dependence who use cocaine at least every 2 weeks
- •Non-treatment seekers who intend to continue using cocaine
- •Male 18-60 years of age
- •Potential participants must be literate in the English language, and be able to understand and complete rating scales and questionnaires accurately
- •Able to provide informed consent
- •Potential participants must be able to identify at least one "locator" person to assist in tracking the participant for follow-up assessments
排除标准
- •Other current substance dependence requiring immediate detoxification
- •Diagnosis of schizophrenia, bipolar disorder, current major depressive disorder
- •Currently suicidal or at high risk for suicide in the judgment of the investigator
- •Carrying a medical device incompatible with MRI (e.g., metal implants such as surgical clips or pacemakers and extensive dental work such as bridges) or suffering from significant claustrophobia that would make MRI unfeasible.
- •Size incompatible with MRI procedures
- •Serious medical illness including HIV-1 infection
- •Hepatitis C + titer with liver enzymes more than 2x normal or a Mini-Mental Status Exam Score of <25/30
- •Insulin dependent diabetes mellitus (IDDM) or non- insulin dependent diabetes mellitus (NIDDM) and abnormal Hemoglobin A1C
- •Severe hepatic or renal impairment
- •History of seizure disorder, delirium, dementia, or mental disorders due to general medical conditions
- •History of head trauma or stroke with lasting neurological sequelae
- •Tardive dyskinesia, extrapyramidal movement disorder, Parkinson's Disease or history of Neuroleptic Malignant Syndrome
- •Clinical or laboratory evidence of uncontrolled hypothyroidism/hyperthyroidism
- •Orthostatic hypotension, defined as a decrease of at > 10 mm Hg in systolic blood pressure and/or an increase in heart rate of > 20 beats per minute, measured one minute following transition from a supine to a standing position.
- •History of allergy or hypersensitivity to Risperidone
- •Treatment with: Neuroleptics, Antidepressants, Antiarrhythmics, Carbamazepine, Phenytoin, Valproate, Rifampin, Phenobarbital, Levodopa and other dopamine agonists, Fluoxetine, Interferon, Propylthiouracil, Methimazole, Opiates.
- •Treatment within 30 days prior to screening with an investigational drug or medication with the potential to influence cocaine use outcomes
研究组 & 干预措施
Placebo
Placebo Comparator
Identical placebo tablets and injections
干预措施: Placebo (Drug)
risperidone consta
Active Comparator
Risperidone 1-2 mg tablets and Risperidone 25 mg injections
干预措施: Risperidone (Drug)
结局指标
主要结局
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
时间窗: 12 weeks
Measure of Dispersion/Precision not calculated, and raw data are no longer available
Cocaine Use by Quantitative Urine Samples
时间窗: 12 weeks
After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below
次要结局
- Amygdala Volume by MRI(12 weeks)
- Cocaine Craving(12 weeks)
研究者
A. Eden Evins
PI
Massachusetts General Hospital
研究点 (1)
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