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SV2A 密度大麻使用障碍

2026年11月2日 更新者:Deepak C. D'Souza、Yale University

The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal [11C]APP-311/[11C]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal [11C]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

42

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。

学习地点

    • Connecticut
      • New Haven、Connecticut、美国、06511
        • Yale University School of Medicine

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

18年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

CUD Participants Inclusion Criteria:

  1. Able to provide informed consent
  2. Male and female 18-75 years old
  3. Daily cannabis use
  4. Positive urine screen for cannabinoids and negative for all other drugs on
  5. Diagnosis of DSM-5 cannabis use disorder (≥ moderate, i.e., ≥ 4 [of 11] symptoms).
  6. Must express a willingness at screening to set a date to attempt to quit using cannabis.
  7. Physically healthy i.e., no clinically unstable medical conditions.
  8. For women of childbearing potential (WOCBP) and men, willingness to practice birth control and to inform study staff immediately if either they (for women) or their partner (for men) becomes pregnant.
  9. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

CUD Participants Exclusion Criteria:

  1. Laboratory tests with clinically significant abnormalities or positive urine toxicology screen with exception of cannabinoids.
  2. Women with a positive pregnancy test or women who are lactating.
  3. Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field
  4. Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
  5. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) Subjects who have donated blood within 8 weeks of the present study
  6. Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
  7. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

Healthy Controls Inclusion Criteria:

  1. Willing and able to give voluntary written informed consent
  2. Male and Female subjects, age 18 to 75 years, inclusive
  3. BMI within 19 to 35 kg/m2, inclusive
  4. Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests.
  5. Negative urine drug screen
  6. If female, not pregnant or breastfeeding
  7. If female of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study and up to one month after completion of PET scans.
  8. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the clinic staff.
  9. Have arterial access sufficient to allow blood sampling as per the protocol.

Healthy Controls Exclusion Criteria:

  1. History or presence of clinically significant and unstable respiratory, GI, renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers.
  2. Abnormal clinically significant laboratory or physical findings during screening
  3. History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
  4. A condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
  5. Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
  6. MRI incompatible implants and other contraindications for MRI, such as pace-maker, artificial joints, non-removable body piercings, metal fragments in head and/or body, or history working with ferrous metals either as a vocation or hobby in such a way that might have led to unknown, indwelling metal fragments that could cause injury during MRI etc.
  7. Subjects who suffer from claustrophobia.
  8. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for healthy volunteers
  9. Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.

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:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:CUD Group

Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart. CUD participants will be asked to abstain from cannabis for the 4 week period.

For each [11C]APP311 (UCB-J) PET scan, up to 20 mCi of [11C]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.

有源比较器:Healthy Controls

Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart.

For each [11C]APP311 (UCB-J) PET scan, up to 20 mCi of [11C]APP311 (UCB-J) will be administered by infusion pump. All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart. Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan.

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
Hippocampal SV2A synaptic density
大体时间:All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart.

Hippocampal SV2A synaptic density will be measured using [11C]APP311 (UCB-J).

All participants will receive at least two [11C]APP311 (UCB-J) PET scans approx. 4 weeks days apart.

次要结果测量

结果测量
措施说明
大体时间
Hippocampal binding and Hippocampal Verbal Memory Task
大体时间:The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period.

To determine the relationship between hippocampal [11C]APP311 (UCB-J) binding and performance on the hippocampal verbal memory task (Auditory Verbal Learning Task [AVLT]), a cognitive task that measures total immediate recall, before and after 4 weeks of confirmed cannabis abstinence.

The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period.
Hippocampal binding and Groton Maze Learning in CUDs
大体时间:The Groton Maze Learning Task will be administered before and after the 4 week abstinence period.

To determine the relationship between hippocampal [11C]APP311 (UCB-J) binding and performance on the Groton Maze Learning task, a cognitive task that measures total number of errors, in CUDs before and after 4 weeks of confirmed cannabis abstinence.

The Groton Maze Learning Task will be administered before and after the 4 week abstinence period.

其他结果措施

结果测量
措施说明
大体时间
Hippocampal synaptic density and first age of cannabis exposure
大体时间:Before and after the 4 week abstinence period.

To determine the relationship between hippocampal synaptic density (n=26+12 historical data) and indices of cannabis exposure such as first age of cannabis exposure, as measured by self-report data.

Before and after the 4 week abstinence period.
Hippocampal synaptic density and cumulative lifetime cannabis exposure.
大体时间:Before and after the 4 week abstinence period.

To determine the relationship between hippocampal synaptic density (n=26+12 historical data) and indices of cannabis exposure such as cumulative lifetime cannabis exposure, as measured by self-report data.

Before and after the 4 week abstinence period.
Hippocampal SV2A synaptic density after 8 weeks
大体时间:Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan. (8 weeks in total).

To explore whether hippocampal synaptic density and function continues to improve with 8 weeks of abstinence in a subset of CUD participants using [11C]APP311 (UCB-J).

Approximately 8 CUD participants will be asked to return for a third [11C]APP311 (UCB-J) PET scan after an additional 4 weeks following their second scan. (8 weeks in total).

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:Deepak C D'Souza、Yale University

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 (实际的)

2022年4月12日

初级完成 (实际的)

2026年4月28日

研究完成 (实际的)

2026年5月14日

研究注册日期

首次提交

2022年7月14日

首先提交符合 QC 标准的

2022年7月20日

首次发布 (实际的)

2022年7月25日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2000032181
  • 1R01DA054314 (美国 NIH 拨款/合同)

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

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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