Cannabidiol Effects on Learning and Anxiety
Primary Purpose
Anxiety and Fear
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Cannabidiol Oral Product
Placebo
Sponsored by

About this trial
This is an interventional basic science trial for Anxiety and Fear focused on measuring social anxiety, fear conditioning, cannabidiol, electrodermal response
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cannabidiol
Placebo
Arm Description
600 mg Cannabidiol Isolate Gel Capsules / participant. One-time dose.
Same number of placebo capsules / participant. One-time dose.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05283382
First Posted
February 23, 2022
Last Updated
May 16, 2022
Sponsor
University of Connecticut
1. Study Identification
Unique Protocol Identification Number
NCT05283382
Brief Title
Cannabidiol Effects on Learning and Anxiety
Official Title
Cannabidiol Effects on Learning and Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Connecticut
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety and Fear
Keywords
social anxiety, fear conditioning, cannabidiol, electrodermal response
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Model Description
Drug group vs. Placebo group
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cannabidiol
Arm Type
Experimental
Arm Description
600 mg Cannabidiol Isolate Gel Capsules / participant. One-time dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Same number of placebo capsules / participant. One-time dose.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oral Product
Intervention Description
Participants will receive a one-time dose of 600 mg Cannabidiol Isolate Gel Capsules in the form of six 100mg capsules.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a one-time dose of placebo capsules in the form of six capsules.
Primary Outcome Measure Information:
Title
Electrodermal activity
Description
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.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Astur, PhD
Phone
18609851239
Email
robert.astur@uconn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cannabidiol Effects on Learning and Anxiety
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