Use of CBD in the Treatment of Anxiety

ConditionsAnxiety Generalized Anxiety Disorder Sleep Problems

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-55

SponsorUniversity of Florida

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

Hemp Derived Cannabidiol Extract
Placebo

Treatment groups

30 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Florida

Lead sponsor

Source ClinicalTrials.gov