CannabisPhase 1NCT05049733

The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A

A Phase 1 study testing CBD 1mg/Kg, CBD 2mg/Kg and CBD 4mg/Kg in people with Cannabis, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cannabis
What is being tested?: CBD 1mg/Kg, CBD 2mg/Kg and CBD 4mg/Kg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2022to 1 Jun 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Have provided written informed consent
Be between the ages of 18 and 55
Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session
Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission

Show all 11Show fewer

Weigh between 110 lbs (50 kg) and 220 lbs (100 kg)
Blood pressure at screening visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
Self-report prior experience using cannabis or CBD products, but no cannabis, cannabinoid, or hemp product use in the prior 30 days
Have not donated blood in the prior 30 days
For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last drug administration session

Who cannot join

Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the past 30 days
History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures
Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing
Epilepsy or a history of seizures.
Individuals with anemia for whom, in the opinion of the study team, participation would pose increased medical risk.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224

Other trials in United States

About this study

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

Read the detailed description

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of a novel hemp-derived oral cannabinoid product, at various doses, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design. Drug administration will be double blind (the participant and research staff will be unaware of the dose administered). Upon enrollment, participants will complete 4 dosing conditions (placebo, 1 mg/kg, 2 mg/kg, 4 mg/kg of cannabinoids). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic (PK) drug effects. Biological specimens (blood and urine) will be obtained throughout these 8 hours to characterize the pharmacokinetics of CBD, CBD-A, delta-9-Tetrahydrocannabinol (THC), and THC-A, as well as other relevant cannabinoids and metabolites. Pharmacodynamic assessments including subjective drug effects, cognitive performance testing, and vital signs will also be collected for 8 hours post-drug administration. For each of the two days after each experimental session, participants will be asked to return to the lab for brief visits (~20 min) to provide additional biospecimens (~24 and ~48 hrs after dosing) to allow for further PK analysis. These procedures will be completed 4 separate times by each participant (sessions will be separated by at least 1 week to allow for sufficient drug washout between doses).

Conditions: Cannabis
Being tested: CBD 1mg/Kg, CBD 2mg/Kg, CBD 4mg/Kg, Placebo CBD
Medical subject headings: Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBD 1mg/KgDrug
Participants will ingest soft gel tablets containing CBD 1mg/Kg
CBD 2mg/KgDrug
Participants will ingest soft gel tablets containing CBD 2mg/Kg
CBD 4mg/KgDrug
Participants will ingest soft gel tablets containing CBD 4mg/Kg
Placebo CBDDrug
Participants will ingest soft gel tablets containing placebo for CBD

Study groups in NCT05049733
Study group	Role	What they receive
Arm 1	Experimental	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. Receives: Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD
Arm 2	Experimental	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. Receives: Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD
Arm 3	Experimental	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. Receives: Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD
Arm 4	Placebo comparator	Participants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods. Receives: Drug: CBD 1mg/Kg; Drug: CBD 2mg/Kg; Drug: CBD 4mg/Kg; Drug: Placebo CBD

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics - maximum concentration (CMax) for CBD
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Measured: 48 hrs
Pharmacokinetics - maximum concentration (CMax) for CBD-A
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Measured: 48 hrs
Pharmacokinetics - maximum concentration (CMax) for THC
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Measured: 48 hrs
Pharmacokinetics - maximum concentration (CMax) for THC-A
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Measured: 48 hrs
Pharmacokinetics - AUC for CBD
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Measured: 48 hrs
Pharmacokinetics - AUC for CBD-A
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Measured: 48 hrs
Pharmacokinetics - AUC for THC
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Measured: 48 hrs
Pharmacokinetics - AUC for THC-A
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Measured: 48 hrs
Pharmacokinetics - Tmax for CBD
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Measured: 48 hrs
Pharmacokinetics - Tmax for CBD-A
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Measured: 48 hrs
Pharmacokinetics - Tmax for THC
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Measured: 48 hrs
Pharmacokinetics - Tmax for THC-A
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Measured: 48 hrs

Secondary outcomes (5)

Driving Under the Influence of Drugs (DRUID) application global impairment score
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Measured: 8 hrs
Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
Measured: 8 hrs
Number of Correct Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
Measured: 8 hrs
Distance from Central Stimulus on the Divided Attention Task (DAT)
Computerized version of Divided Attention Task will be administered to assess divided attention. Will report the mean total distance from the central stimulus (in computer pixels) over the course of the task (higher scores indicate worse performance). Note that there is no defined upper limit to these scores.
Measured: 8 hrs
Feel Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: 8 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Mar 20221 Jun 2023

First posted20 Sep 2021
Study start7 Mar 2022
Primary completion1 Jun 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CannabisStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: All participants will complete all dose conditions (study arms) in a randomized order
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05049733
Sponsor's protocol ID: IRB00290381
Status last verified: Jun 2023
First submitted: 9 Sep 2021
Last updated: 7 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Elder HJ, Zamarripa CA, Klausner M, Wakshlag J, Davis R, Dresser B, Kjaer C, Weerts EM, Vandrey R, Spindle TR. The Pharmacokinetics and Pharmacodynamics of a Hemp-Derived "Full-Spectrum" Oral Cannabinoid Product with a 1:1 Ratio of Cannabidiol to Cannabidiolic Acid and Delta-9-Tetrahydrocannabinol to Delta-9-Tetrahydrocannabinolic Acid: A Double-Blind, Placebo-Controlled, Within-Subjects Human Laboratory Study. Cannabis Cannabinoid Res. 2025 Apr;10(2):e299-e313. doi: 10.1089/can.2024.0187. Epub 2025 Mar 5.
PubMed 40040421

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 ID: NCT05049733
Acronym / sponsor ID: IRB00290381
Conditions: Cannabis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Cultivate Biologics
Study start: 7 Mar 2022 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 20 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4
Model description: All participants will complete all dose conditions (study arms) in a randomized order

Arm	Type	Receives
Arm 1	Experimental	Drug: CBD 1mg/Kg, Drug: CBD 2mg/Kg, Drug: CBD 4mg/Kg, Drug: Placebo CBDParticipants 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.
Arm 2	Experimental	Drug: CBD 1mg/Kg, Drug: CBD 2mg/Kg, Drug: CBD 4mg/Kg, Drug: Placebo CBDParticipants 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.
Arm 3	Experimental	Drug: CBD 1mg/Kg, Drug: CBD 2mg/Kg, Drug: CBD 4mg/Kg, Drug: Placebo CBDParticipants 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.
Arm 4	Placebo comparator	Drug: CBD 1mg/Kg, Drug: CBD 2mg/Kg, Drug: CBD 4mg/Kg, Drug: Placebo CBDParticipants will begin with ingestion of placebo soft gel tablets that do not contain cannabinoids and then switch to other doses after washout periods.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Have provided written informed consent
Be between the ages of 18 and 55
Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session
Test negative for other drugs of abuse, including alcohol, at the screening visit and upon arrival for the experimental session

Key exclusion criteria (8 listed)

Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the past 30 days
History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures
Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant
Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBD 1mg/KgParticipants will ingest soft gel tablets containing CBD 1mg/Kg	Drug	Arm 1, Arm 2, Arm 3, Arm 4
CBD 2mg/KgParticipants will ingest soft gel tablets containing CBD 2mg/Kg	Drug	Arm 1, Arm 2, Arm 3, Arm 4
CBD 4mg/KgParticipants will ingest soft gel tablets containing CBD 4mg/Kg	Drug	Arm 1, Arm 2, Arm 3, Arm 4
Placebo CBDParticipants will ingest soft gel tablets containing placebo for CBD	Drug	Arm 1, Arm 2, Arm 3, Arm 4

Primary outcome

Pharmacokinetics - maximum concentration (CMax) for CBD
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - maximum concentration (CMax) for CBD-A
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - maximum concentration (CMax) for THC
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - maximum concentration (CMax) for THC-A
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration (in nanogram per milliliter, ng/mL) reached for each individual.
Pharmacokinetics - AUC for CBD
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - AUC for CBD-A
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - AUC for THC
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - AUC for THC-A
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated across all timepoints, minus the baseline.
Pharmacokinetics - Tmax for CBD
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - Tmax for CBD-A
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - Tmax for THC
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.
Pharmacokinetics - Tmax for THC-A
Time frame: 48 hrs
Blood cannabinoid concentrations will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The Tmax, or time to reach maximum concentration, is the timepoint at which the Cmax is observed.

5 secondary outcomes

Driving Under the Influence of Drugs (DRUID) application global impairment score
Time frame: 8 hrs
Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Time frame: 8 hrs
Number of Correct Trials on the Digit Symbol Substitution Task (DSST)
Time frame: 8 hrs
Distance from Central Stimulus on the Divided Attention Task (DAT)
Time frame: 8 hrs
Feel Drug Effect as assessed by the Drug Effect Questionnaire (DEQ)
Time frame: 8 hrs

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Derived from this study: PubMed 40040421Elder HJ, Zamarripa CA, Klausner M, Wakshlag J, Davis R, Dresser B, Kjaer C, Weerts EM, Vandrey R, Spindle TR. The Pharmacokinetics and Pharmacodynamics of a Hemp-Derived "Full-Spectrum" Oral Cannabinoid Product with a 1:1 Ratio of Cannabidiol to Cannabidiolic Acid and Delta-9-Tetrahydrocannabinol to Delta-9-Tetrahydrocannabinolic Acid: A Double-Blind, Placebo-Controlled, Within-Subjects Human Laboratory Study. Cannabis Cannabinoid Res. 2025 Apr;10(2):e299-e313. doi: 10.1089/can.2024.0187. Epub 2025 Mar 5.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tory Spindle, PhD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBD 1mg/Kg, CBD 2mg/Kg and CBD 4mg/Kg in people with Cannabis, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics - maximum concentration (CMax) for CBD (time frame: 48 hrs). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05049733, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.