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Cannabidiol Effects on Learning and Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283382
Recruitment Status : Not yet recruiting
First Posted : March 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Robert Astur, University of Connecticut

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Drug group vs. Placebo group
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Basic Science
Official Title: Cannabidiol Effects on Learning and Anxiety
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Cannabidiol

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.




Primary Outcome Measures :
  1. Electrodermal activity [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283382


Contacts
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Contact: Robert Astur, PhD 18609851239 robert.astur@uconn.edu

Sponsors and Collaborators
University of Connecticut
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Responsible Party: Robert Astur, Associate Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT05283382    
Other Study ID Numbers: H21-0159
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Astur, University of Connecticut:
social anxiety
fear conditioning
cannabidiol
electrodermal response
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Cannabidiol
Anticonvulsants