Cannabidiol for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Icahn School of Medicine at Mount Sinai, New York, NYHealthy SubjectsCannabidiol - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if CBD is safe and affects the body in healthy people.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 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

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

Trial Safety

Safety Progress

1 of 3

Side Effects for

CBD Oil Group
38%Tiredness
24%Poor sleep
24%Drowsiness
22%Constipation
18%Poor Appetite
16%Dizziness
9%Headache
7%Diarrhea
7%Nausea
4%Itching
This histogram enumerates side effects from a completed 2022 Phase 2 & 3 trial (NCT04387617) in the CBD Oil Group ARM group. Side effects include: Tiredness with 38%, Poor sleep with 24%, Drowsiness with 24%, Constipation with 22%, Poor Appetite with 18%.

Trial Design

4 Treatment Groups

Cannabidiol 400 mg with standard meal
1 of 4
Cannabidiol 200 mg with standard meal
1 of 4
Epidiolex 400 mg with standard meal
1 of 4
Cannabidiol 400 mg with high fat meal
1 of 4

Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: Cannabidiol · No Placebo Group · Phase 1

Cannabidiol 400 mg with standard meal
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: Drug
Cannabidiol 200 mg with standard meal
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: Drug
Epidiolex 400 mg with standard meal
Drug
Experimental Group · 1 Intervention: Epidiolex · Intervention Types: Drug
Cannabidiol 400 mg with high fat meal
Drug
Experimental Group · 1 Intervention: Cannabidiol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2018
Completed Phase 3
~980
Epidiolex
2015
Completed Phase 1
~170

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial 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

Who is running the clinical trial?

Hurd,Yasmin, Ph.D.Lead Sponsor
5 Previous Clinical Trials
297 Total Patients Enrolled
Yasmin Hurd, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
63 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to fully understand the study information and agree to participate.
You must be able to speak English.

Who else is applying?

What state do they live in?
New York87.5%
California12.5%
How old are they?
18 - 65100.0%
What site did they apply to?
Icahn School of Medicine at Mount Sinai100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I'm interesting in advancing research efforts of cannabidiol and its family of compounds."
What questions have other patients asked about this trial?
  • "Approximately when would this trial begin?"
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Typically responds via
Email50.0%
Phone Call50.0%
Average response time
  • < 1 Day
Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 24 hours

Frequently Asked Questions

How many participants are currently engaged in this research initiative?

"Affirmative, the details listed on clinicaltrials.gov attest to this medical trial's continued recruitment of patients. It was initially announced on May 18th 2022 and has since been revised November 28th 2022. Currently 24 participants are sought from 1 location." - Anonymous Online Contributor

Unverified Answer

Is there an opportunity for me to partake in this experiment?

"This experiment requires 24 participants aged 18-65 with robust health. Criteria for inclusion include: comprehension of informed consent, English language fluency, healthy physical/psychological history and laboratory values, abstention from drugs or nicotine use, and sex as a biological variable (50% female recruitment)." - Anonymous Online Contributor

Unverified Answer

Are there any slots left in this clinical research for new participants?

"According to current information on clinicaltrials.gov, this research is recruiting participants as of now. The initial posting date was May 18th 2022 and the most recent update occurred November 28th 2022." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Cannabidiol for therapeutic use?

"Considering that this is a Phase 1 clinical trial, with limited evidence regarding its safety and efficacy, Cannabidiol scored a 1 on our team's scale." - Anonymous Online Contributor

Unverified Answer

Does this research encompass individuals of advanced age?

"This study is designed for adults aged between 18 and 65. There are, however, 50 trials available to those younger than this set age range and 372 studies targeting senior citizens." - 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.