Cannabidiol Effects on Fear Extinction in Social Phobia

Study Overview
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Brief Summary
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The investigators will randomly assign participants with social anxiety disorder to receive oral cannabidiol (CBD) or placebo. Participants will undergo a fear conditioning and extinction trial, and the investigators will examine whether CBD increases the degree of fear reduction during extinction.

Detailed Description
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This will be a double-blind, randomized controlled trial of cannabidiol (CBD) vs. placebo for potentiating fear extinction in adult outpatients with social anxiety disorder (SAD). After providing written informed consent and passing medical screening, participants will be assessed for SAD and other mental health concerns. They will then engage in a fear conditioning paradigm in which an electrical stimulation is applied to the wrist that is aversive but not painful (at a level determined by each participant) paired with pictures of angry faces. Following the fear conditioning paradigm, they will receive orally administered CBD or placebo. They will then undergo a fear extinction phase in which the conditioned angry faces are shown repeatedly with no further electrical stimulus. Fear toward the conditioned faces following extinction will be measured using galvanic skin response (GSR) and a visual analog scale of self-reported fear. The investigators predict that CBD, compared to placebo, will result in lower GSR and self-reported fear ratings.

Official Title
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Cannabidiol Effects on Fear Extinction in Social Phobia

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Fear extinction
* Drug: Cannabidiol Cap/Tab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and above Any gender Any race/ethnicity Primary diagnosis of SAD according to the DIAMOND At least moderate severity of SAD as evidenced by a DIAMOND severity rating of 4 (moderate) or higher Able to speak, read and write English (this is necessary because the study measures are only validated in English) Concurrent medications will be allowed so long as there is not a substantial risk of interaction with CBD Able/willing to consent to participate in study Exclusion Criteria: <18 years old Active substance use disorder or mania according to the DIAMOND Severe risk of suicide or non-suicidal self-injury in the interviewer's judgment Current or past schizophrenia spectrum disorder according to the DIAMOND Developmental disability, including autism spectrum disorder, according to clinical interview History of organic brain illness or head injury with loss of consciousness > 5 minutes Liver function abnormalities as detected by liver functioning test History of allergic reaction to CBD according to clinical interview Unable or unwilling to abstain from CBD or tetrahydrocannabinol use for 24 hr prior to study participation Pregnancy or lack of adequate contraception Any clinical factors that would preclude the participant from providing informed consent or otherwise participating in the research, according to the interviewer's judgment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to CBD or placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol<br>600 mg oral cannabidiol | Behavioral: Fear extinction<br>* Extinction of conditioned fear response<br>Drug: Cannabidiol Cap/Tab<br>* 6 100-mg capsules<br>* Other names: CBD;|
| Placebo Comparator: Placebo<br>Placebo capsules | Behavioral: Fear extinction<br>* Extinction of conditioned fear response<br>Drug: Placebo<br>* 6 placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin conductance | Galvanic skin responses to conditioned stimuli | Single session (2.5 hours) | 
| Distress ratings | Subjective units of discomfort (0-100, 100 = maximum distress) | Single session (2.5 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol, fear extinction