HealthyEarly Phase 1NCT05232123
Cannabidiol Effects on Cardiovascular System and Exercise Responses
A Early Phase 1 study testing Cannabidiol in people with Healthy, run by Castleton University at 1 site in United States.
Trial summary
To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2023to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female
- 18+ years (aims 3\&4)
- 50+ years (aims 1\&2)
- participants must agree to fast for 4 hours and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session
- participants must agree to avoid exercise for 6 hours prior to each experimental session
- completion of Health History Screening Questionnaire with report indicating overall good health
Show all 9Show fewer
- ability to comprehend and satisfactorily comply with protocol requirements
- written informed consent given prior to study participation
- low-risk for VO2max testing (aims 3\&4)
Who cannot join
- women who are pregnant or lactating
- participants who have a history of adverse reactions to cannabidiol
- current medications that might influence the cardiovascular and/or autonomic systems
- any cardiac, pulmonary, renal, or metabolic disease
- walking difficulty (aims 3\&4)
- waiting for a stress test for a medical reason (aims 3\&4)
- medical contraindication to performing a treadmill stress test (aims 3\&4)
Trial locations and contacts
1 site in 1 country.
United States1 site
Castleton University, Jeffords Science Building
Castleton, Vermont, 05735
About this study
To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery.
Read the detailed description
Heart rate variability (HRV) analysis is a common method used to evaluate the function of the autonomic nervous system. While heart rate is the number of heart beats per minute, HRV is the fluctuation of the time intervals between those beats (interbeat intervals). If the interbeat intervals are too similar, this is an indication of an unhealthy heart. A major influence on heart rate (and thus interbeat interval), is the autonomic nervous system which is divided into two branches: sympathetic and parasympathetic. HRV represents the balance between both systems, with higher HRV being associated with greater parasympathetic activity, and lower HRV with greater sympathetic activity. While there is no optimal level of HRV, a higher HRV is associated with reduced stress and good health, and a lower HRV is associated with chronic diseases and cardiovascular risk. The current study will evaluate the effect of recreationally-relevant doses of CBD (25-200mg) on resting HRV in older adults (aims 1\&2). Investigators will also look at the effects of CBD on cardiovascular fitness by having participants complete a maximum graded exercise test under the influence of a placebo and again after ingesting a single dose of CBD (aims 3\&4).
- Conditions
- Healthy
- Being tested
- Placebo, Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo oral product formulated in MCT (medium chain triglyceride) oil
CannabidiolDrug
Also called CBD
Cannabidiol 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 |
| Cannabidiol 25 mg | Experimental | Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD. Receives: Drug: Cannabidiol |
| Cannabidiol 50 mg | Experimental | Participants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD. Receives: Drug: Cannabidiol |
| 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: Week 5
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: Week 5
Maximal oxygen consumption (VO2max)
Maximum oxygen consumption will be calculated during treadmill test (using the Bruce Protocol)
Measured: 8 days
Heart rate
Change in heart rate will be assessed throughout session
Measured: through study completion, an average of 4 weeks
Secondary outcomes (2)
Blood pressure
Change in blood pressure will be assessed throughout session
Measured: through study completion, an average of 4 weeks
Borg's Category-Ratio Scale for Rating of Perceived Exertion
The Borg Scale is a self-reporting instrument assessing intensity of perceived exertion on a 0 to 10 scale, 0 being rest and 10 maximal effort.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study startJul 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: did not receive funding
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 (one of which is a placebo), thus serving as their own control.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT05232123
- Sponsor's protocol ID
- VBRN Project 2022_Corcoran
- Status last verified
- Mar 2024
- First submitted
- 11 Jan 2022
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol Effects on Cardiovascular System and Exercise Responses
- ClinicalTrials.gov ID
- NCT05232123
- Acronym / sponsor ID
- VBRN Project 2022_Corcoran
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Castleton UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Feb 2022 (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.
To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery.
Detailed description
Heart rate variability (HRV) analysis is a common method used to evaluate the function of the autonomic nervous system. While heart rate is the number of heart beats per minute, HRV is the fluctuation of the time intervals between those beats (interbeat intervals). If the interbeat intervals are too similar, this is an indication of an unhealthy heart. A major influence on heart rate (and thus interbeat interval), is the autonomic nervous system which is divided into two branches: sympathetic and parasympathetic. HRV represents the balance between both systems, with higher HRV being associated with greater parasympathetic activity, and lower HRV with greater sympathetic activity. While there is no optimal level of HRV, a higher HRV is associated with reduced stress and good health, and a lower HRV is associated with chronic diseases and cardiovascular risk. The current study will evaluate the effect of recreationally-relevant doses of CBD (25-200mg) on resting HRV in older adults (aims 1\&2). Investigators will also look at the effects of CBD on cardiovascular fitness by having participants complete a maximum graded exercise test under the influence of a placebo and again after ingesting a single dose of CBD (aims 3\&4).
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 (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. |
| Cannabidiol 25 mg | Experimental | Drug: CannabidiolParticipants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 25 mg of CBD. |
| Cannabidiol 50 mg | Experimental | Drug: CannabidiolParticipants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 50 mg of CBD. |
| Cannabidiol 200 mg | Experimental | Drug: CannabidiolParticipants will ingest 3ml of MCT (medium-chain triglycerides) oil containing 200 mg of CBD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- male or female
- 18+ years (aims 3\&4)
- 50+ years (aims 1\&2)
- participants must agree to fast for 4 hours and abstain from food or beverages containing alcohol, caffeine, or CBD for 12 hours prior to each experimental session
- participants must agree to avoid exercise for 6 hours prior to each experimental session
Key exclusion criteria (7 listed)
- women who are pregnant or lactating
- participants who have a history of adverse reactions to cannabidiol
- current medications that might influence the cardiovascular and/or autonomic systems
- any cardiac, pulmonary, renal, or metabolic disease
- walking difficulty (aims 3\&4)
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 |
|---|---|---|
| PlaceboPlacebo oral product formulated in MCT (medium chain triglyceride) oil | Drug | Placebo |
| CannabidiolAlso: CBDCannabidiol oral product formulated in MCT (medium chain triglyceride) oil | Drug | Cannabidiol 200 mg, Cannabidiol 25 mg, Cannabidiol 50 mg |
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: Week 5
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: Week 5
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.
Maximal oxygen consumption (VO2max)
Time frame: 8 days
Maximum oxygen consumption will be calculated during treadmill test (using the Bruce Protocol)
Heart rate
Time frame: through study completion, an average of 4 weeks
Change in heart rate will be assessed throughout session
2 secondary outcomes
Blood pressure
Time frame: through study completion, an average of 4 weeks
Borg's Category-Ratio Scale for Rating of Perceived Exertion
Time frame: 8 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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 9 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 27 Mar 2024.