RecruitingPhase 2NCT06672666

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

Sponsor

University of Florida

Enrollment

30 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Generalized Anxiety Disorder Sleep Problems

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether CBD (cannabidiol), a non-psychoactive compound found in cannabis, can reduce symptoms of moderate to severe anxiety. Participants will take CBD and be monitored for changes in anxiety levels and overall wellbeing. **You may be eligible if...** - You are between 18 and 55 years old (any sex) - You have moderate to severe anxiety, with a score above 14 on the Hamilton Anxiety Rating Scale - You are willing to donate blood during the study - You agree to use effective contraception throughout the study if you are of childbearing potential - You are in generally good health with normal lab results **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a history of suicidal behavior or thoughts in the past 6 months - You are currently taking medications that may interact with CBD - You have a history of psychosis or substance dependence Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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