Use of CBD in the Treatment of Anxiety

Inclusion Criteria:

• Any biological sex and ages 18 to 55 years old

• Willing and able to give informed consent for participation in the study

• Willing and able to comply with all study requirements, including willingness todonate blood during the study

• Meet diagnosis for moderate to severe anxiety based on a score of more than 14 inthe Hamilton Anxiety Rating Scale (HAM-A)

• Subjects of childbearing potential should use two forms of highly effectivecontraception methods combined (e.g., barrier methods combined with Long-ActingReversible Contraceptives) to be eligible for study participation.

• Normal clinical history and laboratory test

Exclusion Criteria:

• Pregnancy or breastfeeding

• Any history of suicidal behavior or any suicidal ideation in the past six months orat screening

• Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication withinsix weeks of baseline visit.

• Active daily or almost daily (3+ days/week) use of cannabinoids or THC in the pastmonth or any other illicit drug within the past 6 months

• Inability to refrain from using alcohol (4 or more drinks in one occasion or 3+days/week), antiepileptics, antipsychotics, oral antifungals, verapamil,nitrofurantoin, or any other medication in drug classes, such as antibiotics,nonsteroidal anti-inflammatory drugs, herbal and dietary supplements, cardiovasculardrugs, central nervous system agents, or antineoplastic drugs, inducing transaminaseelevation based on the LiverTox database. 17,18

• Inability to adjust the doses of prescription medications displaying a narrowtherapeutic index that are potentially impacted by concomitant cannabinoid use18,19.

• Inability to refrain from using acetaminophen, or topic antifungals on a regularbasis (more than two times per week) over the course of the trial.

• Active use of benzodiazepines, opioids, and antihistamines or any other medicationinducing lethargy and sedation, except for antidepressants, for which detailedinformation will be collected.

• History of liver disease or current liver disease or clinically significantelevation in serum liver chemistries at baseline (i.e., Serum aspartateaminotransferase (AST) or alanine aminotransferase (ALT) >3 times upper limit ofnormal (ULN) or alkaline phosphatase (ALP) >2 times ULN (or the baseline value ifbaseline is elevated); Total serum bilirubin >2.5 mg/dL with elevated AST, ALT orALP; or International normalized ratio (INR) >1.5 with elevated AST, ALT or ALP).20

• Current substance use disorder

• Unstable medical or neurological condition

• Positive drug screen for substances of abuse

• Lifetime history of psychotic disorder, bipolar disorder, PTSD or OCD

• Psychotherapy newly instituted during the 6 weeks leading up to enrollment in thestudy. Subjects established in psychotherapy without change during the course of thestudy may participate.

• Severe depression symptoms in the past six months.

• Known or suspected hypersensitivity to cannabidiol or any other components in theextract.