Donepezil Effects on Cocaine Craving and Pharmacokinetics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cocaine Safety in Subjects Receiving Donepezil
研究概览
简要总结
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
详细描述
This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or intravenous injection within the four weeks prior to screening, and must supply a cocaine-positive urine obtained within four weeks of entry into the study.
排除标准
- •Shows signs of psychostimulant toxicity, or has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
- •Has a current psychiatric disorder other than drug abuse or dependence or dementia.
- •Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
- •Has received opiate-substitution therapy (methadone or buprenorphine) within two months prior to enrollment.
- •Has current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, or family history of seizure disorder.
- •Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral beta-adrenergic agonist.
- •Has had head trauma that resulted in neurological sequelae.
- •Has an unstable medical condition, which, in the judgement of investigators, would make participation hazardous.
研究组 & 干预措施
Oral Placebo First
Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil
干预措施: Donepezil, 5 mg daily (Drug)
Oral Placebo First
Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil
干预措施: Oral Placebo (Other)
Donepezil First
Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.
干预措施: Donepezil, 5 mg daily (Drug)
Donepezil First
Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.
干预措施: Oral Placebo (Other)
结局指标
主要结局
Cocaine Safety in Subjects Receiving Donepezil
时间窗: Two weeks
Patients evaluated for clinical and laboratory adverse events
次要结局
- Cocaine Subjective Effects(3 to 30 minutes)
- Cocaine Pharmacokinetics(0 to 8 hours)