Overview

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

Status:
Completed
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
RTI International
Criteria
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