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Cannabinoid

CBD 1mg/Kg for Cannabis

Phase 1
Waitlist Available
Led By Tory Spindle, 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hrs
Awards & highlights

Study Summary

This trial is testing a new oral product containing CBD and CBD-A to see how it is metabolized and affects the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hrs
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hrs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics - AUC for CBD
Pharmacokinetics - AUC for CBD-A
Pharmacokinetics - AUC for THC
+9 more
Secondary outcome measures
Distance from Central Stimulus on the Divided Attention Task (DAT)
Driving Under the Influence of Drugs (DRUID) application global impairment score
Feel Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3Experimental Treatment4 Interventions
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 4 mg/kg and then switch to other doses after washout periods.
Group II: Arm 2Experimental Treatment4 Interventions
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 2 mg/kg and then switch to other doses after washout periods.
Group III: Arm 1Experimental Treatment4 Interventions
Participants will start with ingestion of soft gel tablets high in CBD and CBD-A, but low in THC and THC-A. The total amount of cannabinoids ingested will be 1 mg/kg and then switch to other doses after washout periods.
Group IV: Arm 4Placebo Group4 Interventions
Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBD 4mg/Kg
2022
Completed Phase 1
~30
Placebo CBD
2022
Completed Phase 1
~30
CBD 1mg/Kg
2022
Completed Phase 1
~30
CBD 2mg/Kg
2022
Completed Phase 1
~30

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
2,260 Previous Clinical Trials
14,820,759 Total Patients Enrolled
7 Trials studying Cannabis
220 Patients Enrolled for Cannabis
Cultivate BiologicsUNKNOWN
Tory Spindle, PhDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
363 Total Patients Enrolled
1 Trials studying Cannabis
47 Patients Enrolled for Cannabis

Frequently Asked Questions

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

Is the target demographic for this investigation limited to those over 55 years of age?

"To join this investigation, patients must be between 18 and 55 years of age. For those below the legal voting age, there are 28 different trials they could participate in while 105 such opportunities exist for senior citizens."

Answered by AI

How many individuals are engaged in the ongoing clinical trial?

"Affirmative. According to the clinicaltrials.gov website, this medical trial has been open since March 7th 2020 and was last updated on September 8th 2022. The research team is currently seeking out 50 participants from a single site for inclusion in their study."

Answered by AI

What is the primary aim of this research endeavor?

"This study is designed to assess the maximum concentration of CBD-A within a 48 hour time frame, serving as its primary outcome. As secondary objectives, researchers will measure participants' working memory performance with Computerized version of Paced Auditory Serial Addition Task (PASAT), divided attention through a computerized Divided Attention Task and acute cognitive and behavioral impairment via the DRUID app global impairment score."

Answered by AI

Have earlier studies been conducted with CBD administered at 1mg/Kg?

"Currently, 79 investigations into the efficacy of CBD 1mg/Kg are ongoing with 16 in Phase 3. Research is mainly concentrated around Ribeirao Preto, Sao Paulo; nevertheless 290 sites across the globe host trials for this cannabinoid therapy."

Answered by AI

Has the administration given its stamp of approval for CBD 1mg/Kg?

"As this is a Phase 1 trial, the safety of CBD 1mg/Kg has been estimated at a rating of 1 due to limited data that support its efficacy and security."

Answered by AI

Are there any vacancies available for prospective participants of this research trial?

"Clinicaltrials.gov reports confirm that this medical trial has been recruiting participants since March 7th 2022 and is still actively looking for patients as of September 8th 2022."

Answered by AI

Is it possible for me to register as a participant in this experiment?

"Candidates with a history of cannabis use should be between 18 and 55 years old to qualify for this trial. There are currently 50 openings available."

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 Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. Johns Hopkins Behavioral Pharmacology Research Unit: < 24 hours
Recent research and studies
clinicaltrials.govStudy
The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A
2022. "The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05049733.
~7 spots leftby Apr 2025
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