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

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabis, Drug Effects
• Intervention / Treatment: Drug: CBD; Drug: THC

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ryan Vandrey, PhD; Phone Number: 410-550-4036; Email: rvandrey@jhmi.edu
• Study Contact Backup: Name: Tory Spindle, PhD; Phone Number: 410-550-0529; Email: tspindle@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins University
      • Contact: Ryan Vandrey; Email: rvandrey@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Have provided written informed consent
2. Be between the ages of 18 and 55
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 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. 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.
7. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
8. Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
9. 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
10. Report prior experience using cannabis or CBD.
11. Have not donated blood in the prior 30 days.
12. Have a smartphone capable of downloading/operating the Redcap mobile application.

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 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.
4. 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.
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).
9. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
10. Epilepsy or a history of seizures.
11. 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
12. Individuals with anemia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD without THC; oral formulation containing 100mg CBD and 0mg THC	Drug: CBD; CBD will be orally ingested
Experimental: CBD with 3.7 mg THC; oral formulation containing 100mg CBD and 3.7mg THC	Drug: CBD; CBD will be orally ingested; Drug: THC; THC will be orally ingested
Experimental: CBD with 2.8 mg THC; oral formulation containing 100mg CBD and 2.8 mg THC	Drug: CBD; CBD will be orally ingested; Drug: THC; THC will be orally ingested

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine cannabinoids	Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)	Day 1, 2, 7, 14, and 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 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.	Day 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.	Day 7
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.	Day 14
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.	Day 21
Blood cannabinoids	Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)	Day 1, 2, 7, 14, and 21
Oral Fluid cannabinoids	Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)	Day 1, 2, 7, 14, and 21

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Ryan Vandrey, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cannabidiol
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: IRB00239558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No