Investigating the Effects of Cannabidiol on Social Anxiety Disorder

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Cannabidiol
  Participants randomized to the cannabidiol arm will receive 3mL of Epidiolex (100mg cannabidiol/mL) in a single-dose.
• Препарат Placebo
  Participants randomized to the placebo arm will receive 3mL of placebo (sesame seed oil) in a single dose.

Первичные конечные точки

• Change in Acute Subjective Anxiety [Срок оценки: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes]

Вторичные конечные точки (1)

• Differences in Salivary Alpha Amylase [Срок оценки: -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Massachusetts Institute of Technology — Cambridge

Идентификаторы

NCT: NCT05649059 · 2206000688

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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