CBDPhase 1/2NCT04778644
Hippocampal Response to Acute Oral Doses of CBD During an fMRI Memory Task
A Phase 1/2 study testing CBD in people with CBD, run by Hartford Hospital at 1 site in United States.
Trial summary
Cannabidiol (CBD) is another cannabis plant derivative for which, like THC, there has been extensive research. Unlike THC however, CBD is non-intoxicating and non-psychedelic. CBD has antipsychotic effects. Logically, if CBD opposes THC effects, it may be a potential antipsychotic treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- CBD
- What is being tested?
- CBD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 15 Dec 2025
- Phase
- Phase 1/2
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50y/o
- Males and females of all races and ethnicities
- Able to provide written informed consent
- Able to read, speak, and understand English
- Meet DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features OR healthy controlled with no diagnosed severe mental illness
- No history of adverse normal baseline values for liver function tests (LFTs)
Who cannot join
- Strongly left-handed individuals defined as a 60:40 or greater ratio of left to right hand preference (assessed using the Edinburgh Handedness Inventory)
- Premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest, age-corrected standardized score)
- Comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months
- Neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovascular disorder, AIDS) that may affect central nervous system function
- Concomitant medications that may interact with study drug adversely such as platelet inhibitors, benzodiazepines, or valproate
- Initial detection of abnormal liver function tests or previous medical history of abnormal liver function or liver disease
Show all 11Show fewer
- Vulnerable populations (e.g., pregnant, nursing, incarcerated); unwilling to use reliable means of contraception
- High risk for suicide defined as more than 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
- Current homicidal ideation with plan and intent such that outpatient care is precluded
- Positive result on breathalyzer or positive urine toxicology test for any substance, including CBD
- History of prior allergic reaction with CBD or CBD-containing products
Trial locations and contacts
1 site in 1 country.
About this study
Cannabidiol (CBD) is another cannabis plant derivative for which, like THC, there has been extensive research. Unlike THC however, CBD is non-intoxicating and non-psychedelic. CBD has antipsychotic effects. Logically, if CBD opposes THC effects, it may be a potential antipsychotic treatment. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug (CBD versus placebo) in patients who have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychosis compared to healthy controls.
Read the detailed description
The investigators conjecture that CBD may act both to modify THC effects and to reduce psychosis symptoms (at least in part) through downstream ECS-related mechanisms, both of which actions converge on the hippocampus, a region rich in CB1 receptors. As such, observing hippocampus activity levels using fMRI can be an effective means of measuring CBD target engagement within this pilot study context. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug cannabidiol (CBD) versus placebo, in BSNIP Biotype 3 compared to Biotypes 1 and 2 and to healthy control subjects, during performance of an fMRI paired associated memory task. Here, investigators will use B-SNIP-based observations in already-characterized B-SNIP subjects, to predict in which individuals CBD engages a theoretically-based brain target. In turn (in future planned studies) such engagement may predict CBD treatment responders. At present, CBD is still an experimental drug for psychosis treatment (although now FDA-approved for treatment of specific types of childhood seizures), but one with a rather benign side-effect profile that could easily be added to ongoing antipsychotic treatment. The purpose of the study is to study response to a single, acute dose of CBD compared to placebo, under double-blind conditions in a small-scale pilot study.
- Conditions
- CBD
- Being tested
- CBD, Placebo
- Keywords
- CBD, Memory, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
Also called CBD Oil, Food grade CBD
Oral gel capsule CBD
PlaceboDrug
Also called Placebo CBD
Oral gel capsule placebo
| Study group | Role | What they receive |
|---|---|---|
| Patients with psychosis | Experimental | People who are part of a dimensionally-organized psychosis sample spanning several serious mental illness diagnoses including schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules. Receives: Drug: CBD; Drug: Placebo |
| Healthy controls | Experimental | People who do not have a diagnosis of schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules. Receives: Drug: CBD; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBD dose-response for fMRI Hippocampal BOLD values
Primary outcome of fMRI-measured hippocampus BOLD values during memory recall task
Measured: Post drug administration at 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Dec 2021
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CBDStudies 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
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will receive both the study drug and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Godfrey Pearlson, Yale University
- Investigators
- Godfrey Pearlson, MD, Principal investigator, Founding Director Olin Research Center; Professor Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778644
- Sponsor's protocol ID
- HHC-2020-0367
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal Response to Acute Oral Doses of CBD During an fMRI Memory Task
- ClinicalTrials.gov ID
- NCT04778644
- Acronym / sponsor ID
- HHC-2020-0367
- Conditions
- CBD
- Keywords
- CBD, Memory, MRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 3 Mar 2021 (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.
Cannabidiol (CBD) is another cannabis plant derivative for which, like THC, there has been extensive research. Unlike THC however, CBD is non-intoxicating and non-psychedelic. CBD has antipsychotic effects. Logically, if CBD opposes THC effects, it may be a potential antipsychotic treatment. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug (CBD versus placebo) in patients who have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder with psychosis compared to healthy controls.
Detailed description
The investigators conjecture that CBD may act both to modify THC effects and to reduce psychosis symptoms (at least in part) through downstream ECS-related mechanisms, both of which actions converge on the hippocampus, a region rich in CB1 receptors. As such, observing hippocampus activity levels using fMRI can be an effective means of measuring CBD target engagement within this pilot study context. The purpose of this pilot research is to show target engagement of the hippocampus with the study drug cannabidiol (CBD) versus placebo, in BSNIP Biotype 3 compared to Biotypes 1 and 2 and to healthy control subjects, during performance of an fMRI paired associated memory task. Here, investigators will use B-SNIP-based observations in already-characterized B-SNIP subjects, to predict in which individuals CBD engages a theoretically-based brain target. In turn (in future planned studies) such engagement may predict CBD treatment responders. At present, CBD is still an experimental drug for psychosis treatment (although now FDA-approved for treatment of specific types of childhood seizures), but one with a rather benign side-effect profile that could easily be added to ongoing antipsychotic treatment. The purpose of the study is to study response to a single, acute dose of CBD compared to placebo, under double-blind conditions in a small-scale pilot study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects will receive both the study drug and placebo.
| Arm | Type | Receives |
|---|---|---|
| Patients with psychosis | Experimental | Drug: CBD, Drug: PlaceboPeople who are part of a dimensionally-organized psychosis sample spanning several serious mental illness diagnoses including schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules. |
| Healthy controls | Experimental | Drug: CBD, Drug: PlaceboPeople who do not have a diagnosis of schizophrenia, schizoaffective disorder, or psychotic bipolar I disorder. Eligible participants will be scheduled for two dose visits where they will receive a 600mg CBD dose on one day and a placebo dose on the other day. Doses will be randomized and double-blind. Doses will be administered via oral gel capsules. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-50y/o
- Males and females of all races and ethnicities
- Able to provide written informed consent
- Able to read, speak, and understand English
- Meet DSM-IV (SCID-based) criteria for schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features OR healthy controlled with no diagnosed severe mental illness
Key exclusion criteria (11 listed)
- Strongly left-handed individuals defined as a 60:40 or greater ratio of left to right hand preference (assessed using the Edinburgh Handedness Inventory)
- Premorbid intellectual ability estimate below 70 (WRAT-4, Word Reading subtest, age-corrected standardized score)
- Comorbid DSM-IV diagnosis of alcohol or substance abuse in prior 1 month or substance dependence in prior 3 months
- Neurological (e.g., seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min) or severe medical condition (e.g., decompensated cardiovascular disorder, AIDS) that may affect central nervous system function
- Concomitant medications that may interact with study drug adversely such as platelet inhibitors, benzodiazepines, or valproate
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 |
|---|---|---|
| CBDAlso: CBD Oil, Food grade CBDOral gel capsule CBD | Drug | Healthy controls, Patients with psychosis |
| PlaceboAlso: Placebo CBDOral gel capsule placebo | Drug | Healthy controls, Patients with psychosis |
Primary outcome
CBD dose-response for fMRI Hippocampal BOLD values
Time frame: Post drug administration at 3 hours
Primary outcome of fMRI-measured hippocampus BOLD values during memory recall task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Godfrey Pearlson, MD principal investigator
Founding Director Olin Research Center; Professor Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBD in people with CBD, 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 6 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 12 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBD dose-response for fMRI Hippocampal BOLD values (time frame: Post drug administration at 3 hours). 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 12 Apr 2024.