The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol

January 22, 2020 updated by: Johns Hopkins University
This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU) and the Johns Hopkins Bayview Clinical Research Unit (CRU). Participants will complete 4 acute drug administration periods, each consisting of a single drug exposure followed by a 5-day observation period (3-days (58-hours) inpatient and 2-days outpatient). Biological specimens will be obtained to characterize the pharmacokinetics of THC, CBD, and their metabolites in whole blood, oral fluid, urine, and hair during this period. Each participant will receive all 4 dose conditions in a counterbalanced order using a placebo controlled within-subject crossover design. The 4 drug conditions are as follows:

  • Condition 1: Inhalation of cannabis vapor containing approximately a 20:1 ratio of CBD:THC and will be measured to deliver a target dose of 100mg CBD and 5mg THC.
  • Condition 2: Inhalation of 100mg CBD vapor.
  • Condition 3: Ingestion of 100mg CBD.
  • Condition 4: Placebo

Drug administration will be double blind and double dummy; both inhalation and oral ingestion of study drugs will occur during all 4 sessions. The order of drug administration will be counterbalanced across participants.

Research volunteers will be recruited until up to 18 participants have completed each of the four study sessions (received Conditions 1-4). Immediately before (baseline) and following each exposure, a battery of assessments including biological fluid collection and testing, subjective questionnaire administration, and performance testing will be conducted for all study participants. Post-exposure testing will be conducted in two phases: a 3-day (58 hour) residential stay, and a 2-day outpatient period, for a total of 5 days. Participants who drop out of the study prior to completion of all 4 drug conditions will be considered "incomplete" and replaced. Approximately one week (minimum of 6 days) will separate the administration of each dose.

The target demographic for study participation are healthy adults who: 1) have a history of intentionally inhaling cannabis/CBD, 2) have not used cannabis in the past month (desire is to have participants free of cannabinoids in biological matrices at the time of initial drug administration), and 3) who are not currently dependent on or seeking treatment for use of cannabis or other psychoactive drugs.

Study outcome variables include quantitative levels of CBD and its primary metabolites, THC and its primary metabolites, results of drug testing procedures conducted in accordance with current federal Mandatory Guidelines for workplace drug testing, subjective drug effect ratings, and performance on behavioral assessments. Biological specimens will be analyzed by an independent laboratory with validated analytical procedures that are specific and accurate for measurement of marijuana constituents and related metabolites. Subjective, cardiovascular and behavioral outcomes will be assessed using multiple regression analyses appropriate for repeated measures testing based on the final characteristics of the data set (e.g. normal distribution, skewness, kurtosis), and correlated with biomarker results of interest.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Behavioral Pharmacology Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Have provided written informed consent
  2. Be between the ages of 18 and 45
  3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
  4. Test negative for recent cannabis use in urine at the screening visit (confirmed by GC/MS laboratory test) and again upon admission for each experimental session
  5. Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
  6. Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
  7. 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.
  8. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
  9. Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
  10. 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
  11. Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
  12. Report prior experience inhaling cannabis (either via smoking or vaporization).

Exclusion Criteria

  1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
  2. 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.
  3. Use of an OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
  4. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
  5. Use of hemp seeds or hemp oil in any form in the past 3 months.
  6. Use of dronabinol (Marinol) within the past 6 months.
  7. 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.
  8. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo oral and vapor
Drug: Placebo
Placebo capsule/vapor
Experimental: Vaporized High Cannabidiol Cannabis
Cannabis containing approximately 100mg cannabidiol and 5mg delta-9-THC
Drug: Oral or vaporized cannabidiol
Acute drug exposure
Experimental: Vaporized Cannabidiol
100mg cannabidiol in vapor
Drug: Oral or vaporized cannabidiol
Acute drug exposure
Experimental: Oral Cannabidiol
100mg oral cannabidiol
Drug: Oral or vaporized cannabidiol
Acute drug exposure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
THC-COOH in Urine
Time Frame: Hour 4
THC-COOH in Urine
Hour 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00128331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual biological testing data will be published. Requests for additional data can be submitted to Dr. Vandrey via e-mail.

IPD Sharing Time Frame

Will be available indefinitely after publication of study findings

IPD Sharing Access Criteria

Request to the study PI

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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