CBDEarly Phase 1NCT04777643
Sex Differences in Neural Response to Cannabidiol
A Early Phase 1 study testing Cannabidiol in people with CBD and Neural Responses, run by Yale University at 1 site in United States.
Trial summary
This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CBD, Neural Responses
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 27 Apr 2023
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-65
- In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
- Body Mass Index between 18.5 and 30
- For females of reproductive potential: agreement to use highly effective contraception during study participation and/or negative pregnancy test prior to fMRI scanning
Who cannot join
- Recent use of cannabis (any past month use)
- Lifetime history of cannabis use disorder
- Lifetime history of chronic pain disorder
- Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
- Presence of any contraindication to MRI scanning
- Known allergic reactions to cannabidiol
Show all 11Show fewer
- Lifetime use of Epidiolex
- Currently taking any medications that could interact with cannabidiol
- Current smoker or tobacco use >1x/week
- Not fluent in English
- Less than 6th grade reading level
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.
- Conditions
- CBD, Neural Responses
- Being tested
- Cannabidiol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
PlaceboOther
Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amygdala activation during stress
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Emotion Regulation Task (ERT). The first primary outcome measure will be amygdala response during the negative emotionality contrast of the ERT during their CBD relative to their placebo scan.
Measured: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Insula activation during social exclusion
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Cyberball Task. The second primary outcome measure will be insula response during the exclusion versus inclusion contrast of the Cyberball Task during their CBD relative to their placebo scan.
Measured: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Secondary outcomes (2)
Patterns of amygdala functional connectivity during stress
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Emotion Regulation Task (ERT). The first secondary outcome measure will be participants' pattern of seed-based functional connectivity with the amygdala during the negative emotionality contrast of the ERT during their CBD relative to their placebo scan.
Measured: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Patterns of insula functional connectivity during social exclusion
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Cyberball Task. The second secondary outcome measure will be participants' pattern of seed-based functional connectivity with the insula during the exclusion versus inclusion contrast of the Cyberball Task during their CBD relative to their placebo scan.
Measured: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start7 Jun 2022
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah D. Lichenstein, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777643
- Sponsor's protocol ID
- 2000029579
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2021
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Because this is a pilot project, we do not plan to share to data. Pending the results of the pilot project, we hope to pursue funding for a larger study to examine sex differences in neural response to CBD more directly (including both male and female participants) and on a larger scale (larger sample than pilot project), and we will plan to make these data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Neural Response to Cannabidiol
- ClinicalTrials.gov ID
- NCT04777643
- Acronym / sponsor ID
- 2000029579
- Conditions
- CBD, Neural Responses
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 2 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.
This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: CannabidiolParticipants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single oral dose of placebo 2 hours prior to fMRI scanning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-65
- In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
- Body Mass Index between 18.5 and 30
Key exclusion criteria (11 listed)
- Recent use of cannabis (any past month use)
- Lifetime history of cannabis use disorder
- Lifetime history of chronic pain disorder
- Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
- Presence of any contraindication to MRI scanning
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 |
|---|---|---|
| CannabidiolParticipants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning. | Drug | Cannabidiol |
| PlaceboParticipants will receive a single oral dose of placebo 2 hours prior to fMRI scanning. | Other | Placebo |
Primary outcome
Amygdala activation during stress
Time frame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Emotion Regulation Task (ERT). The first primary outcome measure will be amygdala response during the negative emotionality contrast of the ERT during their CBD relative to their placebo scan.
Insula activation during social exclusion
Time frame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Participants will complete 1 fMRI scan following CBD administration and another fMRI scan following placebo administration. During each scan, participants will complete the Cyberball Task. The second primary outcome measure will be insula response during the exclusion versus inclusion contrast of the Cyberball Task during their CBD relative to their placebo scan.
2 secondary outcomes
Patterns of amygdala functional connectivity during stress
Time frame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Patterns of insula functional connectivity during social exclusion
Time frame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No. Because this is a pilot project, we do not plan to share to data. Pending the results of the pilot project, we hope to pursue funding for a larger study to examine sex differences in neural response to CBD more directly (including both male and female participants) and on a larger scale (larger sample than pilot project), and we will plan to make these data available to other researchers.
Related trials for CBD
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
RecruitingPhase 1
A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment of Focal-Onset Seizures
Focal Seizures
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Not yet recruitingPhase 4
A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS
Lennox-Gastaut Syndrome
RecruitingEarly Phase 1
Cannabidiol in Opioid Use Disorder and Chronic Pain With Buprenorphine
Chronic Pain, Opioid Use Disorder
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.
Sarah D. Lichenstein, PhD principal investigator
Yale University
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 Cannabidiol in people with CBD and Neural Responses, run by Yale University 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: finished, as of the sponsor's last update on 21 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amygdala activation during stress (time frame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.). 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 21 Dec 2023.