Investigating the Effects of Cannabidiol on Social Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Acute Subjective Anxiety
研究概览
简要总结
The purpose of this study is to test whether a single-dose of Epidiolex (cannabidiol) is associated with reduced psychological, physiological, and neuroimaging measures of anxiety in people diagnosed with social anxiety disorder (SAD).
详细描述
Using a randomized, double-blind, placebo-controlled, parallel-group study design, this scientific investigation will examine the effect of 3 milliliters (mL) of Epidiolex (100mg cannabidiol/mL) on behavioral, physiological, and neuroimaging measures of anxiety in subjects diagnosed with SAD. The study will enroll 50 subjects with SAD who will be randomized in a double-blind manner to receive either Epidiolex or placebo before experiencing the Trier Social Stress Test (TSST), the gold-standard for ethically inducing stress in a controlled laboratory setting. Following the TSST, neuroimaging measures of emotional processing and self-referential processing will be acquired using functional magnetic resonance imaging (fMRI).
This study will be conducted primarily at Massachusetts Institute of Technology with research and clinical support from Massachusetts General Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and willingness to provide written informed consent.
- •Sufficiently fluent in English to participate in the trial.
- •Between 18-55 years of age (inclusive).
- •Right-hand dominant.
- •Current medications are stable for past 30 days (no changes to dose or frequency).
- •Negative result on pregnancy test (if female).
- •Negative result on urine drug screening.
- •Liebowitz Social Anxiety Scale (LSAS ≥ 60).
排除标准
- •History of bipolar disorder, schizophrenia, psychosis, delusional disorders.
- •History of eating disorder within past 6 months.
- •History of any traumatic brain injury.
- •Currently diagnosed with diabetes mellitus.
- •Presence of severe medical illness that would prevent completion of study procedures.
- •Presence of significant neurological illness or cognitive dysfunction (e.g.; seizures, dementia).
- •History of substance use disorder within past 6 months (other than nicotine and caffeine).
- •Use of any cannabis-containing products in past 30 days (CBD or THC).
- •Use of benzodiazepines in past 2 weeks.
- •Use of alpha- or beta-blockers in past week.
- •History of claustrophobia.
- •Contraindications for MRI (e.g.; shrapnel).
- •Presence of any other medical condition that, in the investigator's opinion, may interfere with the study procedures.
- •Use of concomitant medication that has a strong interaction with CBD.
- •History of liver disease.
- •History of hypersensitivity to cannabinoids.
- •History of hypersensitivity to sesame seed oil.
- •Currently breastfeeding (if female).
研究组 & 干预措施
Placebo
Placebo (3mL sesame seed oil), oral, single-dose
干预措施: Placebo (Drug)
Cannabidiol
300mg Cannabidiol (3mL Epidiolex), oral, single-dose
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Change in Acute Subjective Anxiety
时间窗: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Subjective anxiety will be assessed with a modified Visual Analog Mood Scale (VAMS) which utilizes a vertical 100 millimeter (mm) bipolar visual scale between two opposing moods consisting of the following word pairs: calm-excited, relaxed-tense, and tranquil-troubled. Total subjective anxiety for each timepoint will be the average distance from the top for the three-question battery. VAMS will be assessed 15 minutes before drug administration (-180 minutes before start of TSST), 150 minutes after drug administration (-15 minutes before start of TSST), after the Anticipation Phase (-5 minutes before start of TSST), after the Stress Procedures (+10 minutes after start of TSST), after 5 minutes in the Recovery Phase (+20 minutes after start of TSST), and 15 minutes after start of the Recovery Phase (+30 minutes after start of TSST).
Change in Acute Subjective Anxiety
时间窗: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Subjective anxiety will be assessed with a modified Visual Analog Mood Scale (VAMS) which utilizes a vertical 100 millimeter (mm) bipolar visual scale between two opposing moods consisting of the following word pairs: calm-excited, relaxed-tense, and tranquil-troubled. Total subjective anxiety for each timepoint will be the average distance from the top for the three-question battery. VAMS will be assessed 15 minutes before drug administration (-180 minutes before start of TSST), 150 minutes after drug administration (-15 minutes before start of TSST), after the Anticipation Phase (-5 minutes before start of TSST), after the Stress Procedures (+10 minutes after start of TSST), after 5 minutes in the Recovery Phase (+20 minutes after start of TSST), and 15 minutes after start of the Recovery Phase (+30 minutes after start of TSST).
次要结局
- Differences in Salivary Alpha Amylase(-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes)