← Back to Search

Cannabinoid

CBD Pharmacokinetics in Healthy Subjects

Phase 1
Waitlist Available
Led By Yasmin Hurd
Research Sponsored by Hurd,Yasmin, Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial will study the effects of CBD in healthy individuals to see if it is safe and affects them pharmacologically.

Who is the study for?
This trial is for healthy adults aged 18-65 who speak English, are not using any medications or drugs (including nicotine), and have normal liver function. They must use effective contraception if applicable. Pregnant or breastfeeding individuals, those with a history of drug abuse or certain medical conditions, and anyone participating in another drug trial recently cannot join.Check my eligibility
What is being tested?
The study is testing the safety and how the body processes cannabidiol (CBD) in healthy people. It's an open cross-over design which means participants will receive CBD at some point during the study to compare different ways it can be administered.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include allergic reactions to cannabinoids or other ingredients like gelatin/sesame oil used in the product formulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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's timeline: 3 weeks for screening, Varies for treatment, and 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration curve (AUC)
Peak plasma concentration (Cmax)
Safety and adverse effects
Secondary outcome measures
Area under the urine concentration curve (AUC)
Peak urine concentration of CBD (Umax)

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Diarrhea
7%
Nausea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control Group

Trial Design

4Treatment groups
Experimental Treatment
Group I: Test condition 4Experimental Treatment1 Intervention
Cannabidiol 400 mg with high fat meal
Group II: Test condition 3Experimental Treatment1 Intervention
Epidiolex 400 mg with standard meal
Group III: Test condition 2Experimental Treatment1 Intervention
Cannabidiol 400 mg with standard meal
Group IV: Test condition 1Experimental Treatment1 Intervention
Cannabidiol 200 mg with standard meal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hurd,Yasmin, Ph.D.Lead Sponsor
5 Previous Clinical Trials
433 Total Patients Enrolled
Yasmin HurdPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05023070 — Phase 1
Healthy Subjects Research Study Groups: Test condition 1, Test condition 2, Test condition 3, Test condition 4
Healthy Subjects Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05023070 — Phase 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023070 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05023070 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join the clinical research experiment?

"In order to fit the criteria of this clinical trial, prospects must possess healthy subjects (hs) and be within a 18 to 65 year old age bracket. 24 individuals are needed for enrolment."

Answered by AI

How many participants is the maximum capacity for this clinical experiment?

"Unfortunately, the recruitment period for this trial has closed. It was initially advertised on July 22nd 2021 and last updated November 28th 2022. Should you want to investigate other studies, there are presently 841 trials seeking healthy participants (hs) and 79 medical investigations actively recruiting for Cannabidiol trials."

Answered by AI

What potential hazards should one be aware of when using Cannabidiol for therapeutic purposes?

"Due to its status as a Phase 1 trial, our team at Power assigned Cannabidiol a score of one on the safety scale - signaling that there is only preliminary data regarding both efficacy and safety."

Answered by AI

Are there still spots available for individuals to participate in this trial?

"As per the information on clinicaltrials.gov, at this time this medical trial is not seeking out participants. It was initially posted in July 2021 and last updated in November 2022; however, there are still 920 other trials that remain open to recruitment."

Answered by AI

Does this study encompass individuals of advanced age?

"The enrollment criteria states that those aged between 18 and 65 are eligible to participate in the study. There is also a separate cohort of 62 trials for minors, as well as 425 studies targeting senior citizens."

Answered by AI

To what degree has Cannabidiol been the subject of prior investigations?

"Currently, 79 clinical trials are researching the potential of Cannabidiol as a treatment. Of those being monitored, 16 have progressed to Phase 3. Most studies related to this drug take place in Ribeirao Preto, Sao Paulo; however there are 290 sites investigating its use across the globe."

Answered by AI

Who else is applying?

What state do they live in?
California
New Jersey
New York
How old are they?
65+
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long would the screening take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’ve always been interested in this subject. I’m curious to see the effects of the treatment.
PatientReceived 1 prior treatment
I would like to know if using CBD, would improve your condition.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Icahn School of Medicine at Mount Sinai: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Investigation of the Pharmacokinetic Profile of CBD
2021. "Investigation of the Pharmacokinetic Profile of CBD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05023070.
All > Cbd > Epidiolex
~7 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top