Clinical trial

Cannabidiol Effects on Learning and Anxiety

Name
H21-0159
Description
To examine the extent to which Cannabidiol (CBD) enhances fear conditioning extinction in college undergraduates who show elevated social anxiety. Undergraduates who display elevated social anxiety on standard assessments will be recruited at the University of Connecticut. All participants will be put in a standard fear conditioning paradigm where they are conditioned to fear a face that occasionally is followed by a shock to their wrist. The other face never is paired with a shock. After everybody learns this, half of the participants will receive 600 mg CBD Isolate Gel Capsules one time, and the other half will receive a placebo dose. Participants will then be presented with the faces with no shocks, and the rate and duration of extinction as measured by electrodermal response as well as subjective fear ratings via a visual analogue scale will be examined. It is hypothesized that participants that receive CBD will display enhanced extinction compared to the placebo group, as evidenced by reduced electrodermal response and reduced visual analogue fear ratings.
Trial arms
Trial start
2024-02-01
Estimated PCD
2024-12-30
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Cannabidiol Oral Product
Participants will receive a one-time dose of 600 mg Cannabidiol Isolate Gel Capsules in the form of six 100mg capsules.
Arms:
Cannabidiol
Placebo
Participants will receive a one-time dose of placebo capsules in the form of six capsules.
Arms:
Placebo
Size
160
Primary endpoint
Electrodermal activity
20 minutes
Eligibility criteria
Inclusion Criteria: * 18-50 years of age Exclusion Criteria: 1. Difficulties seeing a computer screen 2. Anyone currently taking CBD within the last 24 hours. 3. Anyone using any cannabis product within the last 24 hours. 4. Heart problems or heart disease 5. A neurological disorder such as epilepsy, stroke, multiple sclerosis, tumor, vascular malformations, aneurysm 6. Are currently pregnant or breast-feeding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Drug group vs. Placebo group', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'double blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2023-11-28

1 organization

1 product

1 indication