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临床试验/NCT01730781
NCT01730781招募中不适用

Characterization of CB1 Receptors Using [11-C]OMAR

Yale University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
PET Imaging

研究概览

简要总结

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available.

Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Males ages 18-55
  • For cannabis users:
  • Willing to abstain from cannabis use for four weeks
  • For schizophrenia:
  • Meets DSM-IV-TR criteria for schizophrenia or schizoaffective disorder
  • For prodrome for psychotic illness:
  • Meets SIPS criteria for prodromal syndrome
  • For family history positive:
  • First degree relative with alcoholism
  • For Post-Traumatic Stress Disorder
  • Meets DSM-IV-TR criteria for PTSD
  • Meets DSM-IV-TR criteria for Opioid Use Disorder

排除标准

  • Current neuro-psychiatric illness (including cannabis dependence) or severe systemic disease. Cannabis use disorder is permitted in the cannabis dependent group. Schizophrenia and schizoaffective disorder is permitted in the schizophrenia group. Psychotic symptoms are permitted in the prodromal group. Post-Traumatic Stress Disorder is permitted in the PTSD group and Opioid Use Disorder is permitted in the OUD group.
  • Presence of ferromagnetic metal in the body or heart pacemaker
  • Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits
  • Are claustrophobic

研究组 & 干预措施

Family history of alcoholism

Healthy volunteers with a first degree relative with alcoholism

干预措施: [11-C]OMAR (Radiation)

Prodrome for psychotic illness

Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms

干预措施: [11-C]OMAR (Radiation)

Healthy Volunteers

Healthy volunteers with no current or past major medical or psychiatric history

干预措施: [11-C]OMAR (Radiation)

PTSD-Post Traumatic Stress Disorder

Patients diagnosed with Post Traumatic Stress Disorder

干预措施: [11-C]OMAR (Radiation)

Opioid Use Disorder

Patients diagnosed with Opioid Use Disorder

干预措施: [11-C]OMAR (Radiation)

Schizophrenia

Patients diagnosed with schizophrenia both on medication and off medication

干预措施: [11-C]OMAR (Radiation)

Cannabis dependence

Frequent users of cannabis

干预措施: [11-C]OMAR (Radiation)

结局指标

主要结局

PET Imaging

时间窗: One time within 4 weeks of screening

This study will utilize the radioligand \[11C\]OMAR and High Resolution Research Tomography (HRRT) Positron Emission Tomography (PET) to measure brain CB1 receptor availability in all study populations. Those in the cannabis dependent population of the study will have PET scanning on three occasions: once within four weeks of screening while smoking as usual, once 48-hours later after remaining abstinent, and once four weeks later after remaining abstinent. The change in receptor density at each time point will be evaluated. Those in the other populations will have PET scanning done on one occasion within four weeks of screening.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deepak C. D'Souza

Associate Professor

Yale University

研究点 (2)

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