Safety and Tolerability of Modafinil for Methamphetamine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Heart Rate
研究概览
简要总结
This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •18-65 years old
- •not currently enrolled in a treatment program
- •subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
- •subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
- •women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study
排除标准
- •current diagnosis of alcohol, opiate, or sedative physical dependence
- •ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
- •history of schizophrenia, or bipolar type I disorder
- •present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
- •medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine)
- •Current suicidality or psychosis
- •liver function tests (i.e., liver enzymes) greater than three times normal levels
- •pregnancy or breastfeeding
结局指标
主要结局
Heart Rate
时间窗: Thrice weekly for 7 weeks
Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.
Systolic Blood Pressure
时间窗: Thrice weekly for 7 weeks
Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Diastolic Blood Pressure
时间窗: Thrice weekly for 7 weeks
Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
"Modafinil Side Effects Checklist"
时间窗: Weekly for 7 weeks
Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from "not at all" (0) to "very much (4). The score was determined by units on a scale.
Anxiety as Measured by the Hamilton Anxiety Scale
时间窗: Thrice weekly for 7 weeks
Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.
Depression as Measured by the Hamilton Depression Scale
时间窗: Thrice weekly for 7 weeks
Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.
次要结局
- Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.(Thrice weekly for the first three weeks)