Actively Recruiting
Use of CBD in the Treatment of Anxiety
Led by University of Florida · Updated on 2025-02-03
30
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of CBD in the Treatment of Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any biological sex aged 18 to 55 years old
- Willing and able to give informed consent for participation
- Willing and able to follow all study requirements, including blood donation
- Diagnosed with moderate to severe anxiety by a Hamilton Anxiety Rating Scale score over 14
- Subjects of childbearing potential must use two effective contraception methods combined
- Normal clinical history and laboratory test results
You will not qualify if you...
- Pregnant or breastfeeding
- History of suicidal behavior or ideation in past 6 months or at screening
- Changed SSRI, SNRI, or non-benzodiazepine anxiolytic medication within 6 weeks before baseline
- Active daily or near-daily cannabinoid or THC use in past month, or illicit drug use in past 6 months
- Unable to avoid alcohol, certain medications, or supplements affecting liver enzymes
- Unable to adjust doses of medications with narrow therapeutic index affected by cannabinoids
- Unable to avoid regular use of acetaminophen or topical antifungals during trial
- Active use of benzodiazepines, opioids, antihistamines, or sedative medications except antidepressants
- History or current liver disease or significant liver enzyme elevations at baseline
- 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
- Newly started psychotherapy within 6 weeks before enrollment
- Severe depression symptoms in past 6 months
- Known or suspected allergy to cannabidiol or components of the extract
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
Research Team
R
Robyn R Nelson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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