Differences in Cannabis Impairment and Its Measurement Due to Route of Administration

Johns Hopkins University1 site in 1 country23 target enrollmentStarted: May 1, 2018Last updated: February 21, 2023

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Johns Hopkins University
Enrollment: 23
Locations: 1
Primary Endpoint: Tetrahydrocannabinol (THC) Concentration in Blood

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Basic Science
Masking: Double (Participant, Outcomes Assessor)

Masking Description

Placebo controlled, double blind drug administration

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
•Test negative for recent cannabis use in urine at the screening visit (confirmed by Gas Chromatography (GC)/ Mass Spectrometry (MS) laboratory test) and at clinic admission
•Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
•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
•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).

Exclusion Criteria

•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 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).
•Abnormal EKG result that in the investigator's opinion is clinically significant.
•Epilepsy or a history of seizures.
•Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing