Brain Function and Connectivity in Methamphetamine Dependence: The Link to Neuroinflammation and the Effects of Ibudilast
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)
研究概览
简要总结
Addiction to methamphetamine is a serious health problem in the United States. Right now, there are no medications that a doctor can give someone to help them stop using methamphetamine. More research is needed to develop drugs for methamphetamine addiction. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.
详细描述
Addiction to methamphetamine is a serious health problem in the United States. Right now, there are no medications that a doctor can give someone to help them stop using methamphetamine. More research is needed to develop drugs for methamphetamine addiction. Ibudilast (the study drug) is a drug that could help people addicted to methamphetamine.
The investigators are interested to know if the study drug can help some symptoms that methamphetamine can cause, specifically inflammation in the brain. Inflammation has been shown to affect decision-making. The study drug has anti-inflammatory properties, however it is not yet known whether the drug will reduce inflammation in the brain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •abstinent from all drugs except marijuana and methamphetamine and have a negative urine drug screen on test days
- •Meet diagnosis for recent Methamphetamine-Use Disorder (DSM-V) or does not meet any substance-use disorders
排除标准
- •Known sensitivity to ibudilast
- •Left handed
- •MRI contraindications
- •Clinically significant neurological, endocrine, renal, hepatic, or systemic diseases that would compromise safe participation or confound outcomes
- •Any psychiatric diagnoses or primary psychotic or mood disorders (past depression diagnoses allowed)
- •Any drug use disorder diagnosis besides methamphetamine or tobacco
- •Any recreational or prescriptive use of psychotropic medications
- •Claustrophobia
- •Women who are pregnant or breast-feeding
- •Neurodegenerative diseases that present with neuroinflammation
- •More than 4 weeks abstinent from methamphetamine
- •rs6971 genotype that confers low translocator protein (TSPO) binding affinity to prevent unnecessary radiation exposure
- •Liver disease requiring medication or medical treatment and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit
- •Participation in any drug study in the last 3 months
研究组 & 干预措施
Placebo
Placebo Group will be dosed with a placebo oral tablet twice daily for 6 weeks. Participants will have pre/post evaluations for neuroinflammation and associated behaviors
干预措施: Placebo Oral Tablet (Drug)
Ibudilast
Ibudilast Group will be dosed with ibudilast twice daily for 6 weeks. The first 2 weeks will be 20 mg twice daily followed by 4 weeks of 50 mg twice daily. Participants will have pre/post evaluations for neuroinflammation and associated behaviors
干预措施: Ibudilast (Drug)
Controls
Healthy controls will only undergo baseline evaluations and will not be enrolled in the drug portion of the study.
结局指标
主要结局
Effects of ibudilast on brain function as assessed by magnetic resonance imaging (MRI)
时间窗: 6 weeks
Pre and post differences in brain function will be assessed.
次要结局
- Effects of ibudilast on overall cognitive battery score.(6 weeks)