Imaging Mitochondrial Complex-I in Alcohol Use Disorder
Imaging Mitochondrial Complex-I With [F-18]BCPP-EF Positron Emission Tomography (PET) in Alcohol Use Disorder (AUD)
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名:Rajesh Narendran
- 电话号码:412-647-5176
- 邮箱:narendranr@upmc.edu
学习地点
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- 招聘中
- University of PIttsburgh
-
接触:
- Principal Investigator
- 电话号码:412-647-5176
- 邮箱:narendranr@upmc.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:PET
Positron Emission Tomography Scans |
Radiotracer to measure binding to mitochondria complex -I Radiotracer to measure cerebral glucose metabolism |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dorsolateral prefrontal cortex [F-18]BCPP-EF VT
大体时间:Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3 |
Baseline scan (time 0)
|
|
Orbitofrontal cortex [F-18]BCPP-EF VT
大体时间:Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration in mL/cm3 |
Baseline scan (time 0)
|
|
Medial Prefrontal Cortex [F-18]BCPP-EF VT
大体时间:Baseline scan (time 0)
|
VT is the volume of distribution expressed relative to total plasma radioligand concentration, mL/cm3 |
Baseline scan (time 0)
|
|
Dorsolateral prefrontal cortex [F-18]FDG SUVR
大体时间:Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
|
Orbitofrontal cortex [F-18]FDG SUVR
大体时间:Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
|
Medial Prefrontal Cortex [F-18]FDG SUVR
大体时间:Baseline scan (time 0)
|
SUVR is the standardized uptake value ratio with whole brain activity as a reference region, unitless |
Baseline scan (time 0)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relapse to alcohol severity measure
大体时间:during 8-week follow up
|
Total number of ETG-negative urines (0 to 16) |
during 8-week follow up
|
|
Penn Alcohol Craving Scale (PACS)
大体时间:during 8-week follow up
|
Mean weekly PACS scores (range 0 to 30; higher scores indicate more craving) |
during 8-week follow up
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Categorical relapse to alcohol
大体时间:8-week follow up
|
Abstained v Relapsed v Drop-out |
8-week follow up
|
|
TIme to relapse
大体时间:during 8 week follow up
|
in weeks (0 to 8) |
during 8 week follow up
|
|
Perceived Stress Scale (PSS)
大体时间:during 8-week follow up
|
Mean weekly PSS scores (0 to 40; higher scores indicate more stress) |
during 8-week follow up
|
|
Prefrontal Cortical Thickness
大体时间:Baseline scan (time 0)
|
MRI-derived cortical thickness measure derived using FreeSurfer, in mm |
Baseline scan (time 0)
|
合作者和调查者
调查人员
- 首席研究员:Rajesh Narendran, MD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STUDY24030081
- R01AA031453-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
All individual participant data that underlie the results reported in the publication or upon study completion will be shared after de-identification via NIAAA Data Archive
IPD 共享时间框架
Upon publication or study completion Data will be available as long as it is archived as per NIAAA Data Archive policy
IPD 共享访问标准
Aavailable as per NIAAA Data Archive policy
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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