Clinical trial NCT03122691: Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
Official title: Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Behavioral Pharmacology of Cannabis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: RTI International
name: U.S. Department of Justice
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-04-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Tetrahydrocannabinol (THC) Concentration in Blood
timeFrame: 8 hours
Secondary outcomes:
measure: 11-hydroxy-tetrahydrocannabinol (11-OH-THC)
timeFrame: 8 hours
measure: Tetrahydrocannabinolic Acid (THCCOOH)
timeFrame: 8 hours
measure: Change in Heart Rate
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure
measure: Mean (SD) Peak Change-from-baseline Drug Effect Rating
timeFrame: Up to 5 hours
measure: Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score
timeFrame: 8 hours
measure: Peak Change in Blood Pressure
timeFrame: 8 hours post drug exposure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ryan Vandrey, PhD
role: PRINCIPAL_INVESTIGATOR
References: