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Cannabis, Drug EffectsPhase 1NCT04283019

The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure Conditions

A Phase 1 study testing CBD and THC in people with Cannabis, Drug Effects, 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
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Trial summary

This study will evaluate the pharmacokinetic and pharmacodynamic effects of oral Cannabidiol (with or without low levels of THC), under acute and chronic dosing conditions. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis, Drug Effects
What is being tested?
CBD and THC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
15 Aug 2021to 17 Jun 2024
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 each 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.
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  • Have a body mass index (BMI) in the range of 19 to 36 kg/m2
  • Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
  • 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
  • Report prior experience using cannabis or CBD.
  • Have not donated blood in the prior 30 days.
  • Have a smartphone capable of downloading/operating the Redcap mobile application.

Who cannot join

  • Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.
  • 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 of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
  • Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
  • Use of hemp seeds or hemp oil in any form in the past 3 months.
  • Use of dronabinol (Marinol) within the past 6 months.
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  • History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.
  • 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 who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician
  • Individuals with anemia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21224

Other trials in United States

About this study

This study will evaluate the pharmacokinetic and pharmacodynamic effects of oral Cannabidiol (with or without low levels of THC), under acute and chronic dosing conditions.

Read the detailed description

Participants (N=60), will be randomized to 1 of 3 oral dosing conditions that include: 100mg CBD/3.7mg THC (0.39% THC), 100mg CBD/2.8mg THC (0.3% THC), or 100mg CBD/0mg THC (0.0% THC). Participants will first complete an 8-hour drug administration session and after this initial session, participants will take participants' assigned study drug for the next 14 days at home, twice daily (participants will visit the lab on days 2, 7, and 14). Participants will return on day 21 (after 1 week washout) for a final visit. During the 8-hour session and visits occurring during the following 21 days, participants will provide biospecimens (urine, blood, oral fluid, hair) which will be tested for cannabinoid concentrations. Pharmacodynamic assessments (subjective and cognitive effects) will also be assessed during these visits.

Being tested
CBD, THC
Keywords
Cannabidiol
Medical subject headings
Marijuana Abuse

What participants receive

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

  • CBDDrug

    CBD will be orally ingested

  • THCDrug

    THC will be orally ingested

Study groups in NCT04283019
Study groupRoleWhat they receive
CBD without THCExperimentaloral formulation containing 100mg CBD and 0mg THC
Receives: Drug: CBD
CBD with 3.7 mg THCExperimentaloral formulation containing 100mg CBD and 3.7mg THC
Receives: Drug: CBD; Drug: THC
CBD with 2.8 mg THCExperimentaloral formulation containing 100mg CBD and 2.8 mg THC
Receives: Drug: CBD; Drug: THC

What is being measured

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

  1. Urine cannabinoids

    Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)

    Measured: Day 1, 2, 7, 14, and 21

Secondary outcomes (7)

  1. Subjective drug effects as assessed by the Drug Effect Questionnaire

    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

    Measured: Day 1

  2. Subjective drug effects as assessed by the Drug Effect Questionnaire

    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

    Measured: Day 2

  3. Subjective drug effects as assessed by the Drug Effect Questionnaire

    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

    Measured: Day 7

  4. Subjective drug effects as assessed by the Drug Effect Questionnaire

    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

    Measured: Day 14

  5. Subjective drug effects as assessed by the Drug Effect Questionnaire

    Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect.

    Measured: Day 21

  6. Blood cannabinoids

    Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)

    Measured: Day 1, 2, 7, 14, and 21

  7. Oral Fluid cannabinoids

    Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)

    Measured: Day 1, 2, 7, 14, and 21

Timeline

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

  1. First posted25 Feb 2020
  2. Study start15 Aug 2021
  3. Primary completion17 Jun 2024
  4. Study completion17 Jun 2024

Resources

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
Parallel groups
Model description
Participants (N=60), will be randomized to 1 of 3 oral dosing conditions that include: 100mg CBD/3.7mg THC (0.39% THC), 100mg CBD/2.8mg THC (0.3% THC), or 100mg CBD/0mg THC (0.0% THC).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04283019
Sponsor's protocol ID
IRB00239558
Status last verified
Aug 2024
First submitted
6 Feb 2020
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CBD and THC in people with Cannabis, Drug Effects, 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 12 inclusion and 12 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 Aug 2024. 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. 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?

Urine cannabinoids (time frame: Day 1, 2, 7, 14, and 21). 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 NCT04283019.

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 Aug 2024.

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