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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
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    February 23, 2022
    Last Updated
    May 16, 2022
    Sponsor
    University of Connecticut
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    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

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