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Cannabidiol Effects on Fear Extinction in Social Phobia

Sponsor
Hartford Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06123702
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will randomly assign participants with social anxiety disorder to receive oral cannabidiol (CBD) or placebo. Participants will undergo a fear conditioning and extinction trial, and the investigators will examine whether CBD increases the degree of fear reduction during extinction.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fear extinction
  • Drug: Cannabidiol Cap/Tab
  • Drug: Placebo
 Early Phase 1

Detailed Description

This will be a double-blind, randomized controlled trial of cannabidiol (CBD) vs. placebo for potentiating fear extinction in adult outpatients with social anxiety disorder (SAD). After providing written informed consent and passing medical screening, participants will be assessed for SAD and other mental health concerns. They will then engage in a fear conditioning paradigm in which an electrical stimulation is applied to the wrist that is aversive but not painful (at a level determined by each participant) paired with pictures of angry faces. Following the fear conditioning paradigm, they will receive orally administered CBD or placebo. They will then undergo a fear extinction phase in which the conditioned angry faces are shown repeatedly with no further electrical stimulus. Fear toward the conditioned faces following extinction will be measured using galvanic skin response (GSR) and a visual analog scale of self-reported fear. The investigators predict that CBD, compared to placebo, will result in lower GSR and self-reported fear ratings.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to CBD or placebo.Participants will be randomly assigned to CBD or placebo.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Capsules will be in opaque bottles and the experimenter will not see the contents of the bottle.
Primary Purpose:
Basic Science
Official Title:
Cannabidiol Effects on Fear Extinction in Social Phobia
Anticipated Study Start Date :
Nov 30, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cannabidiol

600 mg oral cannabidiol

Behavioral: Fear extinction
Extinction of conditioned fear response

Drug: Cannabidiol Cap/Tab
6 100-mg capsules
Other Names:
  • CBD

    		•
    Placebo Comparator: Placebo

    Placebo capsules

    Behavioral: Fear extinction
    Extinction of conditioned fear response

    Drug: Placebo
    6 placebo capsules

    Outcome Measures

    Primary Outcome Measures

    1. Skin conductance [Single session (2.5 hours)]

      Galvanic skin responses to conditioned stimuli

    2. Distress ratings [Single session (2.5 hours)]

      Subjective units of discomfort (0-100, 100 = maximum distress)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 18 and above

    2. Any gender

    3. Any race/ethnicity

    4. Primary diagnosis of SAD according to the DIAMOND

    5. At least moderate severity of SAD as evidenced by a DIAMOND severity rating of 4 (moderate) or higher

    6. Able to speak, read and write English (this is necessary because the study measures are only validated in English)

    7. Concurrent medications will be allowed so long as there is not a substantial risk of interaction with CBD

    8. Able/willing to consent to participate in study

    Exclusion Criteria:

    1. <18 years old

    2. Active substance use disorder or mania according to the DIAMOND

    3. Severe risk of suicide or non-suicidal self-injury in the interviewer's judgment

    4. Current or past schizophrenia spectrum disorder according to the DIAMOND

    5. Developmental disability, including autism spectrum disorder, according to clinical interview

    6. History of organic brain illness or head injury with loss of consciousness > 5 minutes

    7. Liver function abnormalities as detected by liver functioning test

    8. History of allergic reaction to CBD according to clinical interview

    9. Unable or unwilling to abstain from CBD or tetrahydrocannabinol use for 24 hr prior to study participation

    10. Pregnancy or lack of adequate contraception

    11. Any clinical factors that would preclude the participant from providing informed consent or otherwise participating in the research, according to the interviewer's judgment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anxiety Disorders Center, Institute of Living Hartford Connecticut United States 06106

    Sponsors and Collaborators

    • Hartford Hospital

    Investigators

    • Principal Investigator: David Tolin, Ph.D., Hartford Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hartford Hospital
    ClinicalTrials.gov Identifier:
    NCT06123702
    Other Study ID Numbers:
    • HHC-2023-0022
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hartford Hospital
    Cannabidiol, fear extinction
    Additional relevant MeSH terms:
    Anxiety Disorders
    Phobia, Social
    Cannabidiol

    Study Results

    No Results Posted as of Nov 9, 2023