Cannabidiol Effects on Fear Extinction in Social Phobia

Social Anxiety Disorder Clinical Trial

Official title:

Cannabidiol Effects on Fear Extinction in Social Phobia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06123702
• Other study ID #: HHC-2023-0022
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: April 30, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Hartford Hospital
• Contact: David Tolin, Ph.D.
• Phone: 860-545-7685
• Email: david.tolin[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Fear extinction
Extinction of conditioned fear response

Drug:
• Cannabidiol Cap/Tab
12 50-mg capsules
• Placebo
12 placebo capsules

Locations

Country	Name	City	State
United States	Anxiety Disorders Center, Institute of Living	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

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