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

NCT04283019 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00239558
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cannabis, Drug Effects

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Urine cannabinoids

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

  Day 1, 2, 7, 14, and 21

Secondary Outcomes (7)

• Subjective drug effects as assessed by the Drug Effect Questionnaire

  Day 1

• Subjective drug effects as assessed by the Drug Effect Questionnaire

  Day 2

• Subjective drug effects as assessed by the Drug Effect Questionnaire

  Day 7

• Subjective drug effects as assessed by the Drug Effect Questionnaire

  Day 14

• Subjective drug effects as assessed by the Drug Effect Questionnaire

  Day 21

Study Arms (3)

CBD without THC

EXPERIMENTAL

oral formulation containing 100mg CBD and 0mg THC

Drug: CBD

CBD with 3.7 mg THC

EXPERIMENTAL

oral formulation containing 100mg CBD and 3.7mg THC

Drug: CBD; Drug: THC

CBD with 2.8 mg THC

EXPERIMENTAL

oral formulation containing 100mg CBD and 2.8 mg THC

Drug: CBD; Drug: THC

Interventions

CBD DRUG

CBD will be orally ingested

CBD with 2.8 mg THC; CBD with 3.7 mg THC; CBD without THC

THC DRUG

THC will be orally ingested

CBD with 2.8 mg THC; CBD with 3.7 mg THC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Substance Abuse And Mental Health Administration: collaborator
• Canopy Growth Corporation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ryan Vandrey, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: dosing will be double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 25, 2020
• Study Start: August 15, 2021
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)