The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol

Phase 1

Completed

• Conditions: Cannabidiol Pharmacokinetics
• Interventions: Drug: Placebo; Drug: Oral or vaporized cannabidiol

• Registration Number: NCT03164512
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Study Start: 2018-06-01
• Primary Completion: 2019-08-29
• Status Verified: 2020-01
• Study Completion: 2020-01-22
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral and vapor
Vaporized High Cannabidiol Cannabis	Oral or vaporized cannabidiol	Cannabis containing approximately 100mg cannabidiol and 5mg delta-9-THC
Vaporized Cannabidiol	Oral or vaporized cannabidiol	100mg cannabidiol in vapor
Oral Cannabidiol	Oral or vaporized cannabidiol	100mg oral cannabidiol

Primary Outcome Measures

Name	Time	Method
THC-COOH in Urine	Hour 4	THC-COOH in Urine

Trial Locations

Locations (1)

Johns Hopkins Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States