Cannabidiol Effects on Fear Extinction in Social Phobia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Fear extinction; Drug: Cannabidiol Cap/Tab; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: David Tolin, Ph.D.; Phone Number: 860-545-7685; Email: david.tolin@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Anxiety Disorders Center, Institute of Living

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsules	Behavioral: Fear extinction; Extinction of conditioned fear response; Drug: Placebo; 12 placebo capsules
Experimental: Cannabidiol; 600 mg oral cannabidiol	Behavioral: Fear extinction; Extinction of conditioned fear response; Drug: Cannabidiol Cap/Tab; 12 50-mg capsules; Other Names: CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin conductance	Galvanic skin responses to conditioned stimuli	Single session (2.5 hours)
Distress ratings	Subjective units of discomfort (0-100, 100 = maximum distress)	Single session (2.5 hours)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cannabidiol, fear extinction
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: HHC-2023-0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No