Social Anxiety DisorderEarly Phase 1NCT06123702
Cannabidiol Effects on Fear Extinction in Social Phobia
A Early Phase 1 study testing Fear extinction and Cannabidiol Cap/Tab in people with Social Anxiety Disorder, run by Hartford Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Fear extinction and Cannabidiol Cap/Tab
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Disorders Center, Institute of Living
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Fear extinction, Cannabidiol Cap/Tab, Placebo
- Keywords
- Cannabidiol, fear extinction
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fear extinctionBehavioural
Extinction of conditioned fear response
Cannabidiol Cap/TabDrug
Also called CBD
12 50-mg capsules
PlaceboDrug
12 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | 600 mg oral cannabidiol Receives: Behavioral: Fear extinction; Drug: Cannabidiol Cap/Tab |
| Placebo | Placebo comparator | Placebo capsules Receives: Behavioral: Fear extinction; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance
Galvanic skin responses to conditioned stimuli
Measured: Single session (2.5 hours)
Distress ratings
Subjective units of discomfort (0-100, 100 = maximum distress)
Measured: Single session (2.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start30 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to CBD or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Tolin, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123702
- Sponsor's protocol ID
- HHC-2023-0022
- Status last verified
- Apr 2024
- First submitted
- 2 Nov 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol Effects on Fear Extinction in Social Phobia
- ClinicalTrials.gov ID
- NCT06123702
- Acronym / sponsor ID
- HHC-2023-0022
- Conditions
- Social Anxiety Disorder
- Keywords
- Cannabidiol, fear extinction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to CBD or placebo.
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Behavioral: Fear extinction, Drug: Cannabidiol Cap/Tab600 mg oral cannabidiol |
| Placebo | Placebo comparator | Behavioral: Fear extinction, Drug: PlaceboPlacebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fear extinctionExtinction of conditioned fear response | Behavioural | Cannabidiol, Placebo |
| Cannabidiol Cap/TabAlso: CBD12 50-mg capsules | Drug | Cannabidiol |
| Placebo12 placebo capsules | Drug | Placebo |
Primary outcome
Skin conductance
Time frame: Single session (2.5 hours)
Galvanic skin responses to conditioned stimuli
Distress ratings
Time frame: Single session (2.5 hours)
Subjective units of discomfort (0-100, 100 = maximum distress)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tolin, Ph.D. principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fear extinction and Cannabidiol Cap/Tab in people with Social Anxiety Disorder, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Tolin, Ph.D. (860-545-7685, david.tolin@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance (time frame: Single session (2.5 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.