HealthyEarly Phase 1NCT04731779
Cannabidiol and Autonomic Function at Rest
A Early Phase 1 study testing cannabidiol in people with Healthy, run by Castleton University at 1 site in United States.
Trial summary
Cannabidiol (CBD) is one of 700 chemicals derived from the Cannabis sativa plant and is both legal and widespread for distribution in the state of Vermont. The central hypothesis of this proposal is that in apparently healthy adults, acute CBD favorably affects the autonomic nervous system and that this will be… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 29 Nov 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, 18-35 years of age.
- Participants must agree to fast and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session.
- Completion of Health History Questionnaire with report indicating overall good health.
- The ability to comprehend and satisfactorily comply with protocol requirements.
- Written informed consent given prior to beginning the study.
Who cannot join
- Current medications that might influence the cardiovascular and/or autonomic systems.
- Women who are pregnant or lactating.
- Participants who have a history of adverse reactions to cannabidiol will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Castleton University, Jeffords Science Building
Castleton, Vermont, 05735
About this study
Official title: Cannabidiol and Autonomic Function in Individuals at Rest
Cannabidiol (CBD) is one of 700 chemicals derived from the Cannabis sativa plant and is both legal and widespread for distribution in the state of Vermont. The central hypothesis of this proposal is that in apparently healthy adults, acute CBD favorably affects the autonomic nervous system and that this will be evident by an increase in heart rate variability. The overall goal is to understand how CBD affects the autonomic and cardiovascular systems at rest, and when perturbed. The investigators will study a narrow age range of adults, administer varying acute doses of CBD, characterize baseline cardiovascular variables, and record responses to autonomic challenge maneuvers. This will provide the framework to assess potential therapies and/or risk factors of CBD, particularly as it relates to healthy individuals. More information that is so widely taken, especially one that targets receptors known to be involved in cardiovascular signaling pathways is imperative.
Read the detailed description
The study will be conducted in the Exercise Physiology Laboratory in the Jeffords Science Building at Castleton University. Participants will be asked to fast overnight, avoid beverages or food containing caffeine, alcohol, or CBD for at least 12h, and to not perform physical effort for 6h prior to each session.
During the initial session, individuals will: have their height and body mass measured, complete a health history questionnaire, and sign a consent form approved by Castleton University's Institutional Review Board. Prior to data collection, individuals will be advised of the possible risks, methods, and potential benefits of this study. They will also be familiarized with the noninvasive cardiovascular monitoring equipment, which they will be putting on themselves. These include an automated blood pressure (BP) cuff and a heart rate (HR) chest strap monitor.
On the day of each experiment, participants will be given a standardized meal and asked to put on the BP cuff and HR monitor. Individuals will remain seated for the length of the experiment (doing nothing or reading). Baseline measurements will be taken remotely following 15 minutes of rest. Under supervision, participants will be asked to consume oral CBD oil (0mg, 25 mg, 50 mg, or 200mg), infused in non-CBD containing MCT (medium-chain triglycerides) oil to standardize dose volume of 3ml. Assessments will be measured remotely at intervals up to 2.5 hours after ingestion. The study will be double-blind, thus neither the participant nor researcher will be aware of the CBD dose for a particular session. Participants will be asked to return for 3 additional consecutive weeks, each session will be a different dose of CBD.
In the final experimental session (to be completed after initial analyses of dose responses), participants will be given a standardized meal and asked to put on the blood pressure cuff and HR monitors. Individuals will remain seated for the length of the experiment. Following 15 minutes of rest, participants will be asked to perform two autonomic stress tests: the isometric hand grip test, and the cold face test. First, the maximum voluntary contraction (MVC) for the isometric hand grip test will be assessed. Participants will be asked to press a handgrip dynamometer with full strength. To perform the isometric handgrip test, participants will again use the dynamometer and maintain handgrip at 30 percent MVC for 2 min. A recovery period of 10 minutes between each test will be observed. For the cold face test, a cold compress (1-2 degrees Celcius) will be applied to the forehead and maxillary region of the subjections face for 2 min. Following these baseline tests, participants will be asked to consume a dose of CBD (determined following analyses of the initial 4 sessions) and perform the two autonomic stress tests again 2h post ingestion.
- Conditions
- Healthy
- Being tested
- cannabidiol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannabidiolDrug
Also called CBD
Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil
PlaceboDrug
Placebo oral product formulated in MCT (medium chain triglyceride) oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will ingest 3ml of non-CBD containing MCT (medium-chain triglycerides) oil. Receives: Drug: Placebo |
| 25 mg | Experimental | Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD. Receives: Drug: cannabidiol |
| 50 mg | Experimental | Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD. Receives: Drug: cannabidiol |
| 200 mg | Experimental | Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 200 mg of CBD. Receives: Drug: cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals.
Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: standard deviation of RR intervals (SDNN). Higher values indicate greater HRV.
Measured: 4 weeks
Change in heart rate variability (HRV) as assessed by time-domain analysis: root mean square of successive differences.
Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: root mean square of successive differences (RMSSD). Higher values indicate greater HRV.
Measured: 4 weeks
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: high-frequency (HF).
Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). A high HF reflects parasympathetic dominance.
Measured: 4 weeks
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: low-frequency (LF).
Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). LF reflects both sympathetic and parasympathetic activity.
Measured: 4 weeks
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: LF/HF ratio.
A low LF/HF ratio reflects parasympathetic dominance, whereas a high LF/HF ratio reflects sympathetic dominance.
Measured: 4 weeks
Change in magnitude of autonomic stress test responses as assessed by changes in blood pressure.
Responses to autonomic stress test include a change in blood pressure if sympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.
Measured: 1 day
Change in magnitude of autonomic stress test responses as assessed by changes in heart rate.
Responses to autonomic stress test include a change in heart rate if parasympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start30 Aug 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Model description
- Each participant will receive a different dose in consecutive weeks (4 doses total, one of which is a placebo), thus serving as their own control.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castleton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Corcoran, Castleton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731779
- Sponsor's protocol ID
- VRBN Pilot 2021_Corcoran
- Status last verified
- May 2023
- First submitted
- 21 Jan 2021
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol and Autonomic Function in Individuals at Rest
- ClinicalTrials.gov ID
- NCT04731779
- Acronym / sponsor ID
- VRBN Pilot 2021_Corcoran
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Castleton UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 1 Feb 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 one of 700 chemicals derived from the Cannabis sativa plant and is both legal and widespread for distribution in the state of Vermont. The central hypothesis of this proposal is that in apparently healthy adults, acute CBD favorably affects the autonomic nervous system and that this will be evident by an increase in heart rate variability. The overall goal is to understand how CBD affects the autonomic and cardiovascular systems at rest, and when perturbed. The investigators will study a narrow age range of adults, administer varying acute doses of CBD, characterize baseline cardiovascular variables, and record responses to autonomic challenge maneuvers. This will provide the framework to assess potential therapies and/or risk factors of CBD, particularly as it relates to healthy individuals. More information that is so widely taken, especially one that targets receptors known to be involved in cardiovascular signaling pathways is imperative.
Detailed description
The study will be conducted in the Exercise Physiology Laboratory in the Jeffords Science Building at Castleton University. Participants will be asked to fast overnight, avoid beverages or food containing caffeine, alcohol, or CBD for at least 12h, and to not perform physical effort for 6h prior to each session.
During the initial session, individuals will: have their height and body mass measured, complete a health history questionnaire, and sign a consent form approved by Castleton University's Institutional Review Board. Prior to data collection, individuals will be advised of the possible risks, methods, and potential benefits of this study. They will also be familiarized with the noninvasive cardiovascular monitoring equipment, which they will be putting on themselves. These include an automated blood pressure (BP) cuff and a heart rate (HR) chest strap monitor.
On the day of each experiment, participants will be given a standardized meal and asked to put on the BP cuff and HR monitor. Individuals will remain seated for the length of the experiment (doing nothing or reading). Baseline measurements will be taken remotely following 15 minutes of rest. Under supervision, participants will be asked to consume oral CBD oil (0mg, 25 mg, 50 mg, or 200mg), infused in non-CBD containing MCT (medium-chain triglycerides) oil to standardize dose volume of 3ml. Assessments will be measured remotely at intervals up to 2.5 hours after ingestion. The study will be double-blind, thus neither the participant nor researcher will be aware of the CBD dose for a particular session. Participants will be asked to return for 3 additional consecutive weeks, each session will be a different dose of CBD.
In the final experimental session (to be completed after initial analyses of dose responses), participants will be given a standardized meal and asked to put on the blood pressure cuff and HR monitors. Individuals will remain seated for the length of the experiment. Following 15 minutes of rest, participants will be asked to perform two autonomic stress tests: the isometric hand grip test, and the cold face test. First, the maximum voluntary contraction (MVC) for the isometric hand grip test will be assessed. Participants will be asked to press a handgrip dynamometer with full strength. To perform the isometric handgrip test, participants will again use the dynamometer and maintain handgrip at 30 percent MVC for 2 min. A recovery period of 10 minutes between each test will be observed. For the cold face test, a cold compress (1-2 degrees Celcius) will be applied to the forehead and maxillary region of the subjections face for 2 min. Following these baseline tests, participants will be asked to consume a dose of CBD (determined following analyses of the initial 4 sessions) and perform the two autonomic stress tests again 2h post ingestion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Each participant will receive a different dose in consecutive weeks (4 doses total, one of which is a placebo), thus serving as their own control.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will ingest 3ml of non-CBD containing MCT (medium-chain triglycerides) oil. |
| 25 mg | Experimental | Drug: cannabidiolParticipants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD. |
| 50 mg | Experimental | Drug: cannabidiolParticipants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD. |
| 200 mg | Experimental | Drug: cannabidiolParticipants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 200 mg of CBD. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, 18-35 years of age.
- Participants must agree to fast and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session.
- Completion of Health History Questionnaire with report indicating overall good health.
- The ability to comprehend and satisfactorily comply with protocol requirements.
- Written informed consent given prior to beginning the study.
Key exclusion criteria (3 listed)
- Current medications that might influence the cardiovascular and/or autonomic systems.
- Women who are pregnant or lactating.
- Participants who have a history of adverse reactions to cannabidiol will be excluded.
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 |
|---|---|---|
| cannabidiolAlso: CBDCannabidiol oral product formulated in MCT (medium chain triglyceride) oil | Drug | 200 mg, 25 mg, 50 mg |
| PlaceboPlacebo oral product formulated in MCT (medium chain triglyceride) oil | Drug | Placebo |
Primary outcome
Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals.
Time frame: 4 weeks
Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: standard deviation of RR intervals (SDNN). Higher values indicate greater HRV.
Change in heart rate variability (HRV) as assessed by time-domain analysis: root mean square of successive differences.
Time frame: 4 weeks
Time-domain measurements quantify the amount of variability of the heart's interbeat (RR) intervals and include the metric: root mean square of successive differences (RMSSD). Higher values indicate greater HRV.
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: high-frequency (HF).
Time frame: 4 weeks
Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). A high HF reflects parasympathetic dominance.
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: low-frequency (LF).
Time frame: 4 weeks
Frequency-domain measurements estimate the distribution of absolute or relative power into four heart rate oscillation frequency bands: ultra-low-frequency (ULF), very-low-frequency (VLF), low-frequency (LF) and high-frequency (HF). LF reflects both sympathetic and parasympathetic activity.
Change in heart rate variability (HRV) as assessed by frequency-domain analysis: LF/HF ratio.
Time frame: 4 weeks
A low LF/HF ratio reflects parasympathetic dominance, whereas a high LF/HF ratio reflects sympathetic dominance.
Change in magnitude of autonomic stress test responses as assessed by changes in blood pressure.
Time frame: 1 day
Responses to autonomic stress test include a change in blood pressure if sympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.
Change in magnitude of autonomic stress test responses as assessed by changes in heart rate.
Time frame: 1 day
Responses to autonomic stress test include a change in heart rate if parasympathetic outflow is activated. The magnitude of change will be compared before and after CBD ingestion.
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 15 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Castleton 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 5 inclusion and 3 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 15 May 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?
Change in heart rate variability (HRV) as assessed by time-domain analysis: standard deviation of RR intervals. (time frame: 4 weeks). The study lists 7 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 15 May 2023.