Cannabidiol Effects on Learning and Anxiety

Sponsor

University of Connecticut (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05283382

Collaborator

(none)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety and Fear	Drug: Cannabidiol Oral Product Other: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Drug group vs. Placebo groupDrug group vs. Placebo group

Masking:

Double (Participant, Investigator)

Masking Description:

double blind

Primary Purpose:

Basic Science

Official Title:

Cannabidiol Effects on Learning and Anxiety

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabidiol 600 mg Cannabidiol Isolate Gel Capsules / participant. One-time dose.	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.
Placebo Comparator: Placebo Same number of placebo capsules / participant. One-time dose.	Other: Placebo Participants will receive a one-time dose of placebo capsules in the form of six capsules.

Arm

Intervention/Treatment

Experimental: Cannabidiol

600 mg Cannabidiol Isolate Gel Capsules / participant. One-time dose.

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.

Placebo Comparator: Placebo

Same number of placebo capsules / participant. One-time dose.

Other: Placebo

Participants will receive a one-time dose of placebo capsules in the form of six capsules.

Outcome Measures

Primary Outcome Measures

Electrodermal activity [20 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18-50 years of age

Exclusion Criteria:

Difficulties seeing a computer screen
Anyone currently taking CBD within the last 24 hours.
Anyone using any cannabis product within the last 24 hours.
Heart problems or heart disease
A neurological disorder such as epilepsy, stroke, multiple sclerosis, tumor, vascular malformations, aneurysm
Are currently pregnant or breast-feeding