Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

Inclusion Criteria:

1. Male or female outpatients aged 18 to 45 years of age

2. A primary mental health complaint (designated by the patient as the most importantsource of current distress and confirmed on Structured Clinical Interview for DSM-5diagnoses by a certified clinical evaluator) of Social Anxiety Disorder (SAD), asdefined by DSM-5 criteria

3. Overall social anxiety severity defined by a Liebowitz Social Anxiety Scale (LSAS)score of at least 60

4. Willingness and ability to participate in the informed consent process and complywith the requirements of the study protocol. Includes compliance with therequirements and restrictions listed in ICF and in the protocol (including consentto abstain from using marijuana, any cannabis-related products, or any tobaccoproducts during the study).

Exclusion Criteria:

1. Known allergy or hypersensitivity to CBD or any of the excipients

2. A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusionaldisorders; obsessive-compulsive disorder or an eating disorder in the past 12months; neurocognitive disorders, intellectual disabilities, communication disordersor other cognitive dysfunction that could interfere with capacity to engage intherapy or complete study procedures; major depressive disorder, substance oralcohol use disorder (other than nicotine) in the last 6 months.

3. Positive urine toxicology for illicit drugs and/or cannabinoids, or self-reporteduse of CBD, THC or marijuana in the past 4 weeks prior to baseline

4. Patients with significant suicidal ideation (assessed by CSSRS SI score greater than

2. or who have enacted suicidal behaviors within 6 months prior to intake will beexcluded from study participation and referred for appropriate clinicalintervention.

5. Patients must be free of concurrent psychotropic medications includingantipsychotics, anticonvulsants, benzodiazepines, and opioids, and medications thatboth have a narrow therapeutic index as determined by the study clinician, and arealso substrates or moderate to strong inhibitors of CYP2C9, CYP2C19, CYP3A5, CYP3A7,UGT1A9, UGT2B7, CYP2C8, CYP1A2 or CYP2B6, or are strong inducers of CYP3A4 orCYP2C19, for at least 4 weeks prior to initiation of randomized treatment.

6. Inability to understand study procedures or informed consent process, or significantpersonality dysfunction likely to interfere with study participation (assessedduring the clinical interview) or inability to comply with study procedures (such asplanned extended travel) assessed on clinical interview.

7. Serious current unstable medical illness, or a condition for which hospitalizationmay be likely within the next year as assessed by medical history and physical exam.If any questions about medical safety emerge with screening procedures, consent willbe formally obtained to contact patient's PCP in order to determine whether anymedical concerns making participation unsafe or not feasible (such as need forextended inpatient care or medications with concern for significant druginteractions and/or safe utilization of CBD) are present.

8. Clinically significant abnormal physical examination, vital signs or 12 lead ECG atscreening. Clinically significant abnormal values for hematology, clinicalchemistry, or urinalysis at screening.

9. Pregnant women (to be ruled out by urine ß-HCG) and women of childbearing potentialwho are not using medically accepted forms of contraception (such as IUD, oralcontraceptives, barrier devices, condoms and foam, or implanted progesterone rodsstabilized for at least 3 months). Men must also be using at least one medicallyaccepted form of contraception.

10. Any concurrent psychotherapy initiated within 3 months of baseline, or ongoingpsychotherapy of any duration directed specifically toward treatment of SAD.Prohibited psychotherapy includes CBT, DBT, ACT, mindfulness-based approaches orpsychodynamic therapy focusing on exploring specific, dynamic causes of the SADsymptomatology and providing management skills. General supportive therapy initiatedgreater than 3 months prior is acceptable.

11. Has received an investigational drug or used an invasive investigational medicaldevice within 1 month or within a period less than 10 times the drug's half-life,whichever is longer, before Day 1

12. Patients with a history of head trauma causing loss of consciousness, seizure orongoing cognitive impairment.

13. Contraindications for MRI including metal implants, surgical clips, probability ofmetal fragments, or braces that are prohibited due to severe risk of injury.

14. Left-handed

15. A prior history of a diagnosis of moderate to severe hepatic dysfunction or currentbilirubin >=1.5X ULN and/or ALT or AST as 2X ULN, and/or if clinically significantsigns and symptoms that are together suggestive of significant hepatic injury (i.e.,nausea, vomiting, right upper quadrant pain, anorexia, fatigue, jaundice, darkurine).