Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
研究概览
简要总结
Studies proposed in this application will image mitochondrial Complex-I (MCI-I) and cerebral glucose metabolism (CGM) in alcohol use disorder (AUD) and matched healthy controls
详细描述
This study uses [18F]BCPP-EF and [18F]FDG positron emission tomography (PET) to image mitochondrial complex I and cerebral glucose metabolism (CGM) in subjects with alcohol use disorder (AUD) and healthy controls (HC). Correlating PET outcome measures with relapse to alcohol in this study will clarify the mechanisms by which abnormal brain energetics modulate addictive behaviors.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alcohol use disorders (AUD)
- •Males or females between 18 and 55 years old
- •fulfill DSM-5 criteria for alcohol use disorder
- •History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week; for females, routinely consuming more than 3 drinks on any day or more than 7 drinks per week) in the past 30 days
- •No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders (unless they are related to alcohol intoxication, withdrawal, or an alcohol- induced mood disorder).
- •No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants. Subjects with moderate and severe DSM-5 cannabis and tobacco use disorder will also be excluded;
- •Subjects 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 medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson's disease, mild or major neurocognitive disorders, and mitochondrial disorders; CGM is altered in diabetes, severe hyperlipidemia, hypertension, obesity), increase the risks associated with blood sampling (anemia), or placement of an arterial line (history of deep vein thrombosis, pulmonary embolism, thrombocytopenia or thrombocytosis) for PET
- •Not currently pregnant or breast-feeding
- •Not currently employed as a radiation worker; or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study [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 55 years old
- •No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- •No history of heavy drinking as defined using NIAAA criteria in the past year
- •5 to 10 above.
排除标准
- 未提供
研究组 & 干预措施
PET
Positron Emission Tomography Scans
干预措施: [F-18]BCPP-EF (Drug)
PET
Positron Emission Tomography Scans
干预措施: [F-18]FDG (Drug)
结局指标
主要结局
Dorsolateral prefrontal 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, mL/cm3
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 in mL/cm3
Medial Prefrontal 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, mL/cm3
Dorsolateral prefrontal cortex [F-18]FDG SUVR
时间窗: Baseline scan (time 0)
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Orbitofrontal cortex [F-18]FDG SUVR
时间窗: Baseline scan (time 0)
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
Medial Prefrontal Cortex [F-18]FDG SUVR
时间窗: Baseline scan (time 0)
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless
次要结局
- Relapse to alcohol severity measure(during 8-week follow up)
- Penn Alcohol Craving Scale (PACS)(during 8-week follow up)
研究者
Rajesh Narendran
Professor of Radiology and Psychiatry
University of Pittsburgh