Imaging Brain Energy Use in Cocaine Use Disorder: a [F-18]BCPP-EF PET Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Orbitofrontal Cortex [F-18]BCPP-EF VT
研究概览
简要总结
Studies proposed in this application will image mitochondrial Complex-I in cocaine use disorder (CUD) and matched healthy controls
详细描述
This study uses [18F]BCPP-EF positron emission tomography (PET) to image mitochondrial complex-I in subjects with cocaine use disorder (CUD) and healthy controls (HC). Correlating PET outcome measures with relapse to cocaine in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.
This study is supported by "the NIH The Helping to End Addiction Long-term® Initiative, HEAL Initiative (https://www.nih.gov/heal)"
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Cocaine use disorders (CUD)
- •Males or females between 18 and 45 years old.
- •fulfill DSM-5 criteria for moderate or severe (4+ criteria) cocaine use disorder.
- •No lifetime DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder, and developmental disorders.
- •No comorbid DSM-5 major depressive or severe anxiety disorders (including cocaine-induced mood and anxiety disorders) in the past 12 months.
- •No comorbid DSM-5 alcohol, opioids, sedative-hypnotics, hallucinogens, and inhalant use disorders in the past 12 months. Subjects with a moderate to severe DSM-5 cannabis use disorder will also be excluded.
- •Not currently on psychotropic or medical medications that can influence binding to MC-I (e.g., metformin) or CGM (e.g., insulin, GLP-1 agonists), or increase the risks associated with an arterial line (e.g., warfarin, clopidogrel, aspirin, naproxen, ibuprofen, etc.).
- •No comorbid medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson' disease, mild or major neurocognitive disorders, mitochondrial disorders, immune disorders; and CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), or are a contraindication for blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis).
- •Not currently pregnant or breast-feeding.
- •Not currently employed as radiation worker; or has not participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in previous radioactive drug studies and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of radiotracers.
- •No medical or psychiatric contraindications to undergo an MRI scan (such as ferromagnetic tattoos/piercings, implants, medical equipment, history of gunshot, and claustrophobia).
- •Healthy controls (HC)
- •Males or females between 18 and 45 years old.
- •No DSM-5 psychiatric or substance use disorder other than tobacco use disorder
- •6 to 10 above.
排除标准
- 未提供
研究组 & 干预措施
PET
[F-18]BCPP-EF
干预措施: [F-18]BCPP-EF (Drug)
结局指标
主要结局
Orbitofrontal Cortex [F-18]BCPP-EF VT
时间窗: Baseline scan (time 0)
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Midbrain [F-18]BCPP-EF VT
时间窗: Baseline scan (time 0)
VT is the volume of distribution expressed relative to total plasma radioligand concentration
Ventral Striatum [F-18]BCPP-EF VT
时间窗: Baseline scan (time 0)
VT is the volume of distribution expressed relative to total plasma radioligand concentration
次要结局
未报告次要终点
研究者
Rajesh Narendran
Professor of Radiology and Psychiatry
University of Pittsburgh