NCT01490216终止1 期
Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period
研究概览
简要总结
The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving.
详细描述
Evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving as determined by self-report and cocaine-positive urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence
- •Used cocaine at least four days in the past month
- •Individuals must be in good general health
- •Individuals must be capable of giving informed consent and capable of complying with study procedures
- •Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception; 2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.
排除标准
- •Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
- •Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period
- •Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
- •Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
- •Individuals with current suicidal risk
- •Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
- •Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, diastolic blood pressure > 90, or heart rate > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases (< 3x upper limit of normal are acceptable), or uncontrolled diabetes
- •Individuals with a history of seizures, hyperthyroidism and/or glaucoma
- •History of allergic reaction to study medication
- •Women who are pregnant or nursing
- •Currently being prescribed psychotropic medication by another physician (other than sleep medication)
- •Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program
研究组 & 干预措施
lisdexamfetamine
Other
open label
干预措施: lisdexamfetamine (Drug)
结局指标
主要结局
maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period
时间窗: Study weeks 3-6
次要结局
未报告次要终点
研究者
研究点 (1)
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