Use of CBD in the Treatment of Anxiety

Eligibility 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 to donate blood during the study
• * Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A)
• * Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation.
• * Normal clinical history and laboratory test
• * Pregnancy or breastfeeding
• * Any history of suicidal behavior or any suicidal ideation in the past six months or at screening
• * Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of baseline visit.
• * Active daily or almost daily (3+ days/week) use of cannabinoids or THC in the past month 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, cardiovascular drugs, central nervous system agents, or antineoplastic drugs, inducing transaminase elevation based on the LiverTox database. 17,18
• * Inability to adjust the doses of prescription medications displaying a narrow therapeutic index that are potentially impacted by concomitant cannabinoid use18,19.
• * Inability to refrain from using acetaminophen, or topic antifungals on a regular basis (more than two times per week) over the course of the trial.
• * Active use of benzodiazepines, opioids, and antihistamines or any other medication inducing lethargy and sedation, except for antidepressants, for which detailed information will be collected.
• * History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries at baseline (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) \>2 times ULN (or the baseline value if baseline is elevated); Total serum bilirubin \>2.5 mg/dL with elevated AST, ALT or ALP; 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 the study. Subjects established in psychotherapy without change during the course of the study may participate.
• * Severe depression symptoms in the past six months.
• * Known or suspected hypersensitivity to cannabidiol or any other components in the extract.