Investigating the Effects of Cannabidiol on Social Anxiety Disorder

ConditionPhobia, Social

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-55

SponsorMassachusetts Institute of Technology

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: CannabidiolActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Acute Subjective Anxiety

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).

Time frame

-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes

Secondary outcomes

Differences in Salivary Alpha Amylase

Physiological stress will be assessed indirectly with salivary alpha amylase (sAA) activity which is regulated by the sympathetic branch of the autonomic nervous system. Samples will be collected using the SalivaBio Oral Swab (SOS) from Salimetrics. Participants will place the SOS in their mouth for 1-2 minutes at each timepoint to collect saliva. sAA 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).

Time frame

-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes

Other outcomes

Differences in fMRI BOLD Response

Patterns of brain activation measured as blood-oxygenation-level dependent (BOLD) signals will be assessed using 3.0 Tesla (3T) functional magnetic resonance imaging (fMRI). Several exploratory imaging paradigms, including the emotional face-matching task (EFMT) and the self-referential comment task (SRCT), will be used to examine differences between participants who receive Epidiolex (cannabidiol) and those that receive placebo. Neuroimaging will begin approximately 210 minutes after drug administration (+45 minutes after the TSST).

Time frame

+45 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Institute of Technology

Lead sponsor

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov

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