Cannabidiol Effects on Fear Extinction in Social Phobia

NCT06123702 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: HHC-2023-0022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Cannabidiol, fear extinction

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Cannabidiol

EXPERIMENTAL

600 mg oral cannabidiol

Behavioral: Fear extinction; Drug: Cannabidiol Cap/Tab

Placebo

PLACEBO COMPARATOR

Placebo capsules

Behavioral: Fear extinction; Drug: Placebo

Interventions

Fear extinction BEHAVIORAL

Extinction of conditioned fear response

Cannabidiol; Placebo

Cannabidiol Cap/Tab DRUG

12 50-mg capsules

Also known as: CBD

Cannabidiol

Placebo DRUG

12 placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Anxiety Disorders Center, Institute of Living

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• David Tolin, Ph.D.

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Tolin, Ph.D.

CONTACT

860-545-7685; david.tolin@hhchealth.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Capsules will be in opaque bottles and the experimenter will not see the contents of the bottle.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to CBD or placebo.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 9, 2023
• Study Start: April 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)