The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol

NCT03164512 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00128331
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion.

Conditions

Cannabidiol Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• THC-COOH in Urine

  THC-COOH in Urine

  Hour 4

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo oral and vapor

Drug: Placebo

Vaporized High Cannabidiol Cannabis

EXPERIMENTAL

Cannabis containing approximately 100mg cannabidiol and 5mg delta-9-THC

Drug: Oral or vaporized cannabidiol

Vaporized Cannabidiol

EXPERIMENTAL

100mg cannabidiol in vapor

Drug: Oral or vaporized cannabidiol

Oral Cannabidiol

EXPERIMENTAL

100mg oral cannabidiol

Drug: Oral or vaporized cannabidiol

Interventions

Oral or vaporized cannabidiol DRUG

Acute drug exposure

Oral Cannabidiol; Vaporized Cannabidiol; Vaporized High Cannabidiol Cannabis

Placebo DRUG

Placebo capsule/vapor

Placebo

Eligibility Criteria

• Age: 18 Years - 45 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 45
• 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 (confirmed by GC/MS laboratory test) 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
• Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
• 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
• Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).
• Report prior experience inhaling cannabis (either via smoking or vaporization).

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 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.
• 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.
• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

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: placebo controlled, double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: June 1, 2018
• Primary Completion: August 29, 2019
• Study Completion: January 22, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Will be available indefinitely after publication of study findings
• Access Criteria: Request to the study PI

Locations

US (1)