Citicoline Treatment of Methamphetamine Dependence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo
研究概览
简要总结
The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.
详细描述
This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who use methamphetamine as their preferred drug of abuse.
- •Subjects must be between the ages of 18 and 45 years.
- •Subjects must have recent methamphetamine use (within 6 months of screening).
- •Subjects must have an established residence and phone.
- •Subjects must be able to give informed consent.
排除标准
- •Significant current or past medical, neurological, or psychiatric co-morbidity including cardiovascular, renal, and endocrine disorder, as identified by medical history.
- •Pregnant subjects - due to the unknown effects of MRI on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded. Female subjects who are of child-bearing potential will have to pass a urine pregnancy test before each visit.
- •Subjects who, in the investigator's judgment, pose a current serious homicidal or suicidal risk.
- •Subjects who will not likely be able to comply with the study protocol.
- •Subjects who have any contraindication to an MR scan.
- •Hypersensitivity to any of the study drugs or excipients
- •Subjects with current DSM-IV diagnosis of a major mental illness. Major illness will be defined as Major Depression, Manic Depression, Schizophrenia, Dissociative Disorder, other psychotic illnesses, Attention-Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, Borderline Personality Disorder, Reactive Attachment Disorder, and Panic Disorder.
- •Predominant alcohol or other substance dependence as preferred drug of abuse.
- •Positive HIV test result.
- •An individual having any pending legal or criminal charge or action, or who has pending or a reasonable potential for court involvement, or a person who is incarcerated or is in detention, or who is pending or having completed a competency evaluation or commitment procedure.
- •Healthy Control Subject Eligibility:
- •Inclusion Criteria:
- •Subjects must be between the ages of 18 and 45 years.
- •Subjects must be able to give informed consent.
- •To have an established residence and phone.
- •Exclusion Criteria:
- •Significant medical, neurological, or psychiatric disorders
- •Pregnant subjects - due to the unknown effects of MRI on a fetus. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded. Female subjects who are of child-bearing potential will have to pass a urine pregnancy test before each visit.
- •Subjects who have any contraindication to an MR scan.
- •Subjects unable to comply with protocol.
- •Positive HIV test result.
- •Positive urine drug screen.
研究组 & 干预措施
Citicoline
In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.
干预措施: Citicoline (Drug)
Placebo
In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo
时间窗: 8 weeks, assessed twice weekly starting week1
Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.
次要结局
- Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects.(Neuroimaging will occur at week 0 and week 8/9)
- Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use.(Throughout the course of the study)
- Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance.(Neuropsychological testing will occur at week 0 and week 8/9)
研究者
Perry Renshaw
Professor of Psychiatry
University of Utah