Cytidine-5'-Diphosphate-choline Treatment in Amphetamine Type Stimulant-using Adolescents
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
研究概览
简要总结
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline in amphetamine-type stimulants-using adolescents.
详细描述
This study is a 12-week, randomized, double-blind, placebo-controlled trial of cytidine-5'-diphosphate choline (CDP-choline) in amphetamine-type stimulants-using adolescents. Multi-level assessments will be performed to determine whether CDP-choline administration with supportive psychotherapy, compared to placebo administration with supportive psychotherapy, will 1) repair ATS-induced neural cell damage of the target brain regions, 2) improve cognitive deficits and normalize the relevant target neural circuits, and then 3) reduce ATS-taking behaviors in ATS-using adolescents.
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
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 14-40 years
- •Amphetamine (or amphetamine-like) use disorder (DSM-IV-TR)
- •Informed consent
- •Seeking treatment
排除标准
- •Major medical or neurological illnesses
- •Psychiatric illnesses requiring hospitalization, prescription of psychotropic medications, or emergency psychiatric interventions
- •Current and past diagnosis of a psychotic disorder, bipolar disorder, conduct disorder, or attention-deficit hyperactivity disorder
- •Occasional ATS use (less than monthly use)
- •IQ of 80 or lower
- •Pregnancy or breastfeeding
- •Clinically significant suicidal or homicidal ideation
- •Substance use disorders (substances other than amphetamine or MA)
研究组 & 干预措施
CDP-choline+supportive psychotherapy
CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
干预措施: CDP-choline (Drug)
CDP-choline+supportive psychotherapy
CDP-choline 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
干预措施: Supportive psychotherapy (Behavioral)
Placebo+supportive psychotherapy
Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
干预措施: Placebo (Drug)
Placebo+supportive psychotherapy
Placebo 500mg once a day for 12 weeks / Supportive psychotherapy 1 session/2 weeks for 12 weeks
干预措施: Supportive psychotherapy (Behavioral)
结局指标
主要结局
the total number of amphetamine- and methamphetamine(MA)-negative samples using urine screening
时间窗: baseline through 12 weeks
abstinence which is defined as five or more consecutive weeks of amphetamine- and MA-negative samples
时间窗: baseline through 12 weeks
treatment program retention
时间窗: baseline through 12 weeks
次要结局
- standardized scores on a neuropsychological test battery(baseline and 12 weeks)
- structural brain changes in magnetic resonance imaging assessed by computational approaches(baseline and 12 weeks)
- number of participants with adverse events(baseline through 12 weeks)
- functional brain changes in magnetic resonance imaging assessed by computational approaches(baseline and 12 weeks)
- metabolic brain changes in magnetic resonance imaging assessed by computational approaches(baseline and 12 weeks)
研究者
Sujung Yoon
Professor
Ewha Womans University Mokdong Hospital