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
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Anxiety and Fear
• Anxiety Disorders

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