Cannabidiol Effects on Learning and Anxiety

NCT05283382 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: H21-0159
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Fear

Keywords

social anxiety; fear conditioning; cannabidiol; electrodermal response

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol Oral Product

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cannabidiol Oral Product DRUG

Participants will receive a one-time dose of 600 mg Cannabidiol Isolate Gel Capsules in the form of six 100mg capsules.

Cannabidiol

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269-1020, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Robert Astur, PhD

CONTACT

2032369938; robert.astur@uconn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Drug group vs. Placebo group

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 17, 2022
• Study Start: October 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)