Status:
TERMINATED
A Clinical Trial of a Hemp-Derived Cannabidiol Product for Anxiety
Lead Sponsor:
Mclean Hospital
Conditions:
Anxiety
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This open-label to double-blind study evaluates the impact of cannabidiol (CBD) on anxiety in adults. Participants will use a custom-formulated sublingual (under-the-tongue) solution of whole plant, h...
Detailed Description
This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived product in individuals with anxiety. Despite the recent interest in medical cannabis and cann...
Eligibility Criteria
Inclusion
- Subject has provided informed consent
- Subject is 18 or older
- Subject is a native English speaker or acquired English prior to age 5
- Subject endorses moderate or severe anxiety at the screening visit
Exclusion
- Non-native English speakers
- Estimated IQ \< 75
- Current substance abuse/dependence, psychotic disorder, bipolar disorder, or an eating disorder
- A history of head injury or loss of consciousness greater than 5 minutes
- Currently uses marijuana or cannabinoid-based products more frequently than 1x/month
- Female subjects will be excluded if they have a positive urine pregnancy test, or if they are currently breastfeeding
- Presence of a serious medical illness, including liver or kidney disease, or neurological disorder
- Allergy to coconut oil
- Current use of valproate
- Additional exclusions related to MR imaging, including claustrophobia, metal implanted within the body, etc.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04286594
Start Date
February 1 2021
End Date
August 24 2023
Last Update
August 27 2024
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478