Cannabidiol for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Healthy Subjects (HS)
Cannabidiol - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether cannabidiol can be safely administered in a nanoemulsion.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

This trial is evaluating whether Cannabidiol will improve 3 primary outcomes and 2 secondary outcomes in patients with Healthy Subjects (HS). Measurement will happen over the course of Study Visit 1 Day.

Study Visit 1 Day
Safety and adverse effects
Hour 24
Area under the urine concentration curve (AUC)
Peak urine concentration of CBD (Umax)
Hour 24
Area under the plasma concentration curve (AUC)
Peak plasma concentration (Cmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Side Effects for

Cannabidiol
Temporary increased seizures
60%
Behavioral Issues
40%
Right eye exotropia and redness/intermittent exotropia without redness
20%
Facial Skin Infection
20%
Tiredness
20%
Left Eye Vertical Nystagmus
20%
Pneumonia
20%
Increased aspartate aminotransferase liver function test
20%
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02332655) in the Cannabidiol ARM group. Side effects include: Temporary increased seizures with 60%, Behavioral Issues with 40%, Right eye exotropia and redness/intermittent exotropia without redness with 20%, Facial Skin Infection with 20%, Tiredness with 20%.

Trial Design

4 Treatment Groups

Test condition 1
1 of 4
Test condition 4
1 of 4
Test condition 2
1 of 4
Test condition 3
1 of 4
Experimental Treatment

This trial requires 24 total participants across 4 different treatment groups

This trial involves 4 different treatments. Cannabidiol is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Test condition 1
Drug
Cannabidiol 200 mg with standard meal
Test condition 4
Drug
Cannabidiol 400 mg with high fat meal
Test condition 2
Drug
Cannabidiol 400 mg with standard meal
Test condition 3
Drug
Epidiolex 400 mg with standard meal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the cbd capsules.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time point -60,15, 30, 45 and 60 minutes and 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the cbd capsules. for reporting.

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).
English speakers.
Ability to understand and give informed consent;
Being healthy as determined by study physician according to screening medical and psychiatric history, physical examination, vitals, ECG and safety laboratory values. Only healthy volunteers with normal hepatic laboratory values will be enrolled.
Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications.

Patient Q&A Section

Does cannabidiol improve quality of life for those with healthy subjects (hs)?

"The present double-blind study suggests that cannabidiol does not improve physical component of QOL or the overall mental/sociological well-being of volunteers with healthy subjects. This is the preliminary report to the literature." - Anonymous Online Contributor

Unverified Answer

What are the signs of healthy subjects (hs)?

"A combination of the presence of a family history of heart disease and BMI of above 30, or a waist circumference greater than 102 cm is most significant in identifying the healthy subjects (hs)." - Anonymous Online Contributor

Unverified Answer

How many people get healthy subjects (hs) a year in the United States?

"Each year, 4.9 million US adults are diagnosed with chronic disease. These include a mean of 62.0 years old men and women, or almost 16% of US adults over 65 years of age. A majority of these individuals (69.6%) have chronic disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for healthy subjects (hs)?

"Healthy subjects often undergo a variety of health screening and related medical procedures. The prevalence and use of such preventive and diagnostic procedures are increasing in a large and varied variety of medical specialties, underscoring the important contribution that medical care plays to population mental health. It is important that the patient-doctor relationship and the practice patterns in these settings be described." - Anonymous Online Contributor

Unverified Answer

What is healthy subjects (hs)?

"Healthy subjects (hs) are individuals of a population where the risk or development of disease has not yet occurred. Therefore, a definition that specifies a population where a cohort of people have been screened does not meet the concept of healthy." - Anonymous Online Contributor

Unverified Answer

What causes healthy subjects (hs)?

"In children, age and sex had the strongest effects. In adults, however, age and race also had significant effects. hs of the same sex displayed a much larger range of adiposity than hs of dissimilar sex, but both sexes displayed a much larger range of adiposity than hs." - Anonymous Online Contributor

Unverified Answer

Can healthy subjects (hs) be cured?

"Laser irradiation of the irradiated area of the oral cavity is well tolerated in hs. The laser at irradiated areas has the ability to increase the number of viable lymphocytes and reduces the percentage of T-cells. The laser irradiation can possibly increase the number of CD4(+) /CD8(+) T subgroups, and decrease the percentage of CD20(+) B cells in oral cavity of hs. Hs who are irradiated on the oral cavity can be cured of bacterial gingivitis/periodontitis without the need for further therapy and long-term antibiotics application." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating healthy subjects (hs)?

"New medical advances have been made in recent years, but progress has been modest. However, studies are needed to demonstrate whether new discoveries, if any, would benefit hs. Because most evidence in medical research was done using hs, current research can be very helpful for identifying promising study designs to test in hs." - Anonymous Online Contributor

Unverified Answer

What is cannabidiol?

"CBD can be found in all [legal] edible hemp products and in several [commonly cultivated] ornamental plants. The CBD content of these plants is widely variable. This variation underscores the need for new standardization of CBD extraction from food plants. The CBD content in food plants can be quantified using a variety of different analytical approaches. Moreover, the composition of food oil, which is an important factor in CBD intake, can be investigated using (gas) chromatography-mass spectrometry. The development of such standardized CBD analysis procedures will enhance the utilization of CBD in food/drug products and help ensure the safety of consumption." - Anonymous Online Contributor

Unverified Answer

Has cannabidiol proven to be more effective than a placebo?

"The addition of cannabidiol to a low-glycemic diet in obese hs subjects significantly reduced body weight and waist circumference as well as other metabolic profile variables. The cannabinoid receptor 2-selective receptor agonists is being developed with the aim of producing better anti-obesity and anti-diabetic properties compared with cannabidiol. Cannabinoid receptor agonists such as rimonabant have the ability to treat metabolic and cardiovascular disease, but there has been concern about their safety and other side effects in humans, leading to a temporary halt to development and testing. Cannabinoid receptor agonists are now undergoing evaluation in clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cannabidiol?

"CBD has several common adverse effects in healthy subjects, and the side effects reported differ from those of placebo. Most common are dry mouth, insomnia, increased appetite, nausea, and dizziness." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for healthy subjects (hs)?

"Patients with chronic disease, and patients who are not well enough to undergo the required study treatment are most likely to need hs for their hs. In most medical trials, hs are excluded because of their lack of relevance for the test. Patients, patients' relatives, and hs are the groups most likely to be affected by the study treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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