Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- CB1R Availability
研究概览
简要总结
The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) by measuring cannabinoid receptor 1 (CB1R) availability.
详细描述
The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand [11C] OMAR, in healthy individuals and individuals diagnosed with opioid use disorder. Research participants may complete screening, MRI, PET scan and follow up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent
- •Male and female 18 years and older
- •DSM-5 diagnosis of opioid use disorder (for OUD group)
- •Physically healthy i.e., no clinically unstable medical conditions
- •Written informed consent and have capacity to consent and comply with study procedures
排除标准
- •Current neuro-psychiatric illness or severe systemic disease (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
- •Hematocrit values lower than 30
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers with no current or past major medical or psychiatric history
干预措施: [11C]OMAR (Drug)
Opioid Use Disorder
Patients diagnosed with opioid use disorder
干预措施: [11C]OMAR (Drug)
结局指标
主要结局
CB1R Availability
时间窗: One time within 4 weeks of screening
To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.
次要结局
- Serum Endocannabinoid Levels(One time within 4 weeks of screening)
研究者
Anahita Bassir Nia
Assistant Professor of Psychiatry
Yale University