NCT05472818招募中早期 1 期
SV2A Density Cannabis Use Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Hippocampal SV2A synaptic density
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CUD Participants Inclusion Criteria:
- •Able to provide informed consent
- •Male and female 18-75 years old
- •Daily cannabis use
- •Positive urine screen for cannabinoids and negative for all other drugs on
- •Diagnosis of DSM-5 cannabis use disorder (≥ moderate, i.e., ≥ 4 [of 11] symptoms).
- •Must express a willingness at screening to set a date to attempt to quit using cannabis.
- •Physically healthy i.e., no clinically unstable medical conditions.
- •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.
- •Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.
- •CUD Participants
排除标准
- •Laboratory tests with clinically significant abnormalities or positive urine toxicology screen with exception of cannabinoids.
- •Women with a positive pregnancy test or women who are lactating.
- •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
- •Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
- •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
- •Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
- •Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.
- •Healthy Controls Inclusion Criteria:
- •Willing and able to give voluntary written informed consent
- •Male and Female subjects, age 18 to 75 years, inclusive
- •BMI within 19 to 35 kg/m2, inclusive
- •Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests.
- •Negative urine drug screen
- •If female, not pregnant or breastfeeding
- •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.
- •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.
- •Have arterial access sufficient to allow blood sampling as per the protocol.
- •Healthy Controls Exclusion Criteria:
- •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.
- •Abnormal clinically significant laboratory or physical findings during screening
- •History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto)
- •A condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
- •Medications that could alter synaptic density and, therefore, confound the interpretation of study data.
- •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.
- •Subjects who suffer from claustrophobia.
- •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
- •Additional criteria not disclosed here in order to minimize the risk of ineligible subjects enrolling in the study.
研究组 & 干预措施
Healthy Controls
Active Comparator
Participants will be scanned using anatomical magnetic resonance imaging (MRI) and PET. All participants will receive two PET scans, 4 weeks apart.
干预措施: [11C]APP311 (Drug)
CUD Group
Active Comparator
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.
干预措施: [11C]APP311 (Drug)
结局指标
主要结局
Hippocampal SV2A synaptic density
时间窗: 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).
次要结局
- Hippocampal binding and Groton Maze Learning in CUDs(The Groton Maze Learning Task will be administered before and after the 4 week abstinence period.)
- Hippocampal binding and Hippocampal Verbal Memory Task(The Auditory Verbal Learning Task (AVLT) will be administered before and after the 4 week abstinence period.)
研究者
Deepak C. D'Souza
Professor of Psychiatry
Yale University
研究点 (1)
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