NCT01007539已完成3 期
Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Urinary drug screening test
研究概览
简要总结
The purpose of the study is to determine if cytidine 5'diphosphocholine (CDP-choline, a naturally occurring chemical in your body) has efficacy in reducing the methamphetamine craving of the subjects with methamphetamine dependence craving and helping them maintain the abstinence. In addition, investigators will measure the brain N-acetyl aspartate (a biologic marker for neuronal viability) level of participants to determine if brain deficits induced by methamphetamine may recover by taking CDP-choline.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-60 year-old male or female
- •Methamphetamine dependence diagnosed by DSM-IV
- •Total cumulative dose for methamphetamine during the last two years: over 10 gram (over 200 shots of 0,05 mgram intravenous methamphetamine injection)
- •Methamphetamine use in recent 4 weeks
- •Subscale score of drug use in ASI: >2
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
- •Lifetime axis I psychiatric disorders of bipolar disorder, schizophrenia, identified by SCID-IV
- •Socially dysfunctional antisocial personality disorder
- •Current alcohol or nicotine dependence identified by SCID-IV
- •Taking psychotropic medication in recent two months
- •Head trauma history with loss of consciousness or seizure
- •Intelligence quotient < 80
- •Pregnant subjects. 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.
- •Any contraindication to an MR scan
研究组 & 干预措施
Placebo (fructose)
Placebo Comparator
干预措施: Placebo (fructose) (Dietary Supplement)
CDP-choline
Experimental
干预措施: CDP-choline (Dietary Supplement)
结局指标
主要结局
Urinary drug screening test
时间窗: 0-8 week visits
次要结局
- Craving symptoms(0-8 week visits)
- Depressive symptoms(0-8 week visits)
- Anxiety symptoms(0-8 week visits)
- Side effect check(1-8 week visits)
- Neuropsychological test battery(0, 8 week visits)
- Clinical Global Impression(0-8 week visits)
- Alcohol and tobacco use(0, 4, 8 week visits)
- Addiction severity index(0, 8 week visits)
- Withdrawal symptoms(0-8 week visits)
- Magnetic Resonance Scan(0, 8 week visits)
- Self-reported drug diary(0-8 week visits)
研究者
In Kyoon Lyoo, MD, PhD, MMS
Professor
Seoul National University Hospital
研究点 (2)
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