Status:
NOT_YET_RECRUITING
Cannabidiol Effects on Fear Extinction in Social Phobia
Lead Sponsor:
Hartford Hospital
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 t...
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 writ...
Eligibility Criteria
Inclusion
- Age 18 and above
- Any gender
- Any race/ethnicity
- Primary diagnosis of SAD according to the DIAMOND
- At least moderate severity of SAD as evidenced by a DIAMOND severity rating of 4 (moderate) or higher
- Able to speak, read and write English (this is necessary because the study measures are only validated in English)
- Concurrent medications will be allowed so long as there is not a substantial risk of interaction with CBD
- Able/willing to consent to participate in study
Exclusion
- \<18 years old
- Active substance use disorder or mania according to the DIAMOND
- Severe risk of suicide or non-suicidal self-injury in the interviewer's judgment
- Current or past schizophrenia spectrum disorder according to the DIAMOND
- Developmental disability, including autism spectrum disorder, according to clinical interview
- History of organic brain illness or head injury with loss of consciousness \> 5 minutes
- Liver function abnormalities as detected by liver functioning test
- History of allergic reaction to CBD according to clinical interview
- Unable or unwilling to abstain from CBD or tetrahydrocannabinol use for 24 hr prior to study participation
- Pregnancy or lack of adequate contraception
- Any clinical factors that would preclude the participant from providing informed consent or otherwise participating in the research, according to the interviewer's judgment
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06123702
Start Date
April 30 2024
End Date
December 31 2024
Last Update
April 19 2024
Active Locations (1)
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1
Anxiety Disorders Center, Institute of Living
Hartford, Connecticut, United States, 06106