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NCT05283382 Clinical Trial

Cannabidiol Effects on Learning and Anxiety

Anxiety and Fear Clinical Trial

Official title:
Cannabidiol Effects on Learning and Anxiety

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05283382
Other study ID # H21-0159
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date February 1, 2024
Est. completion date February 1, 2025

Study information
Verified date November 2023
Source University of Connecticut
Contact Robert Astur, PhD
Phone 18609851239
Email robert.astur@uconn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date February 1, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cannabidiol Oral Product
Participants will receive a one-time dose of 600 mg Cannabidiol Isolate Gel Capsules in the form of six 100mg capsules.
Other:
• Placebo
Participants will receive a one-time dose of placebo capsules in the form of six capsules.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Connecticut

Outcome
Type Measure Description Time frame Safety issue
Primary Electrodermal activity Electrodermal response as measured by galvanic skin response electrodes that are attached to two of the fingers via sticker electrodes. These passively measure the conductance of the sweat glands on the fingers. 20 minutes
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