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Imaging Mitochondrial Complex-I in Alcohol Use Disorder

2026年9月11日 更新者:Rajesh Narendran

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

介入性

注册 (估计的)

100

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • 招聘中
        • University of Pittsburgh
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Alcohol use disorders (AUD)

  1. Males or females between 18 and 55 years old
  2. fulfill DSM-5 criteria for alcohol use disorder
  3. 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
  4. 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).
  5. 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;
  6. 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.).
  7. 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
  8. Not currently pregnant or breast-feeding
  9. 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
  10. 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)

  1. Males or females between 18 and 55 years old
  2. No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
  3. No history of heavy drinking as defined using NIAAA criteria in the past year
  4. 5 to 10 above.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rajesh Narendran, MD、University of Pittsburgh

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2032年12月31日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2026年9月11日

首先提交符合 QC 标准的

2026年9月11日

首次发布 (实际的)

2026年9月17日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY24030081
  • R01AA031453-01A1 (其他赠款/资助编号:NIAAA)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

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

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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