Use of CBD in the Treatment of Anxiety
A Pilot Double-Blind Placebo-Controlled, Randomized, Safety, Efficacy, and Acceptability Trial of a Hemp-Derived Cannabidiol Extract for the Treatment of Anxiety
University of Florida
30 participants
Jan 6, 2025
INTERVENTIONAL
Conditions
Summary
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 Criteria6
- 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 Criteria16
- 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.
Interventions
Participants will be given the study drug in a titrated method of 50-150mgs per day for 4 weeks
Partcipants will be given placebo substance to be taken with titrated instructions that mimic IP dispensing method daily for 4 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06672666