Overview

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

Eligibility

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 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

Exclusion Criteria:

• 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.