Sex Differences in Neural Response to Cannabidiol
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Amygdala activation during stress
研究概览
简要总结
This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female, aged 18-65
- •In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
- •Body Mass Index between 18.5 and 30
- •For females of reproductive potential: agreement to use highly effective contraception during study participation and/or negative pregnancy test prior to fMRI scanning
排除标准
- •Recent use of cannabis (any past month use)
- •Lifetime history of cannabis use disorder
- •Lifetime history of chronic pain disorder
- •Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
- •Presence of any contraindication to MRI scanning
- •Known allergic reactions to cannabidiol
- •Lifetime use of Epidiolex
- •Currently taking any medications that could interact with cannabidiol
- •Current smoker or tobacco use >1x/week
- •Not fluent in English
- •Less than 6th grade reading level
研究组 & 干预措施
Cannabidiol
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
干预措施: Cannabidiol (Drug)
Placebo
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
干预措施: Placebo (Other)
结局指标
主要结局
Amygdala activation during stress
时间窗: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Emotion Regulation Task (ERT). The first primary outcome measure will be amygdala response during the negative emotionality contrast of the ERT during their CBD relative to their placebo scan.
Insula activation during social exclusion
时间窗: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Cyberball Task. The second primary outcome measure will be insula response during the exclusion versus inclusion contrast of the Cyberball Task during their CBD relative to their placebo scan.
次要结局
- Patterns of amygdala functional connectivity during stress(fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.)
- Patterns of insula functional connectivity during social exclusion(fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.)