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
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.
Description
Approximately one-third (33.1%) of Americans will experience an anxiety disorder at some point in their lifetime. Anxiety disorders are primarily treated with antidepressants or benzodiazepines, but unfortunately, many patients report a partial response or cannot tolerate the side effects of these medications, which include risk for abuse, cognitive impairment, and even death. The therapeutic potential of various compounds derived from the Cannabis sativa plant has generated considerable interest, particularly for managing neuropsychiatric disorders that have limited treatment options. Among t…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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 partic…
Interventions
- DrugHemp Derived Cannabidiol Extract
Participants will be given the study drug in a titrated method of 50-150mgs per day for 4 weeks
- DrugPlacebo
Partcipants will be given placebo substance to be taken with titrated instructions that mimic IP dispensing method daily for 4 weeks
Location
- University of FloridaGainesville, Florida