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Cannabinoid

CBD for Cannabis Effects

Phase 1
Recruiting
Led By Ryan Vandrey, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
Be between the ages of 18 and 55
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 7, 14, and 21
Awards & highlights

Study Summary

This trial will give cannabidiol to people to see if it is effective and safe.

Who is the study for?
This trial is for adults aged 18-55 in good health, with a BMI of 19-36 kg/m2, and prior experience using cannabis or CBD. Participants must not be pregnant, nursing, or have used drugs/alcohol recently. They should have no significant medical/psychiatric issues and not be on certain medications that could affect the study.Check my eligibility
What is being tested?
The study examines how oral Cannabidiol (CBD), alone or with low levels of THC, affects the body under different dosing conditions. It looks at both immediate (acute) and long-term (chronic) effects to understand how CBD behaves over time.See study design
What are the potential side effects?
Potential side effects may include dry mouth, changes in appetite or mood swings due to CBD; THC might cause dizziness, altered senses or coordination issues. However, specific side effects will depend on individual reactions to these substances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not use recreational drugs or alcohol.
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 2, 7, 14, and 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 2, 7, 14, and 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urine cannabinoids
Secondary outcome measures
Blood cannabinoids
Oral Fluid cannabinoids
Subjective drug effects as assessed by the Drug Effect Questionnaire

Trial Design

3Treatment groups
Experimental Treatment
Group I: CBD without THCExperimental Treatment1 Intervention
oral formulation containing 100mg CBD and 0mg THC
Group II: CBD with 3.7 mg THCExperimental Treatment2 Interventions
oral formulation containing 100mg CBD and 3.7mg THC
Group III: CBD with 2.8 mg THCExperimental Treatment2 Interventions
oral formulation containing 100mg CBD and 2.8 mg THC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
THC
2017
Completed Phase 1
~330

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,045 Total Patients Enrolled
Ryan Vandrey, PhDPrincipal InvestigatorJohns Hopkins University
12 Previous Clinical Trials
465 Total Patients Enrolled

Frequently Asked Questions

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

If I meet the requirements, can I join this experiment?

"To be admitted into this study, cannabis users that are between 18-55 years old must express interest. Currently, the trial is looking for around 120 participants."

Answered by AI

How many people are currently a part of this experiment?

"That is accurate. As of September 21st, 2022, the clinical trial detailed on clinicaltrials.gov is recruiting patients. The study, which was created on August 15th, 2021, is seeking a total of 120 individuals from 1 location."

Answered by AI

Are there other ongoing or previous research projects that have studied THC?

"83 studies that involve THC are currently being conducted. Of those, 18 are in the final stage of research. The majority of these studies are based in Brazil, more specifically Ribeirao Preto, Sao Paulo; although, there are 311 locations worldwide conducting these trials."

Answered by AI

Does this experiment only include elderly patients over the age of 60?

"This particular clinical trial is for patients aged 18-55. If you are not in this age group, there are 29 other trials for those under 18 and 104 trials for those over 65."

Answered by AI

Are there any available opening for participants in this research?

"That is correct. The online clinicaltrials.gov registry currently lists this trial as recruiting patients. This study, which was originally posted on August 15th, 2021, is looking for 120 participants from 1 location."

Answered by AI

Are there adverse effects to THC use?

"Given that this is only a Phase 1 trial with limited data to support THC's efficacy and safety, our team at Power has given it a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University
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 does screening take?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure Conditions
2021. "The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04283019.
~0 spots leftby May 2024
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