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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03122691

Enrollment

Registered

2017-04-21

Start date

2018-05-01

Completion date

2020-02-01

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral Pharmacology of Cannabis

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.

Interventions

DRUGcannabis

Cannabis will be self-administered by study participants

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Placebo controlled, double blind drug administration

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Tetrahydrocannabinol (THC) Concentration in Blood	8 hours	Quantitation of active drug (THC) in whole blood (ng/ml).

Secondary

Measure	Time frame	Description
Tetrahydrocannabinolic Acid (THCCOOH)	8 hours	Quantitation of THC metabolite in blood (ng/ml).
Change in Heart Rate	Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure	Peak change from baseline
11-hydroxy-tetrahydrocannabinol (11-OH-THC)	8 hours	Quantitation of THC metabolite in blood (ng/ml)
Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score	8 hours	Composite Global Impairment Score on the DRUID (DRiving Under the Influence of Drugs) App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance. ≥13-point change (from baseline) on DRUID global impairment score = impaired; \<13-point change (from baseline) = not impaired.
Peak Change in Blood Pressure	8 hours post drug exposure	Systolic and Diastolic blood pressure will be measured at baseline and repeatedly for 8 hours after drug exposure. Outcome is the peak change from baseline assessed within the 8 hour period of assessment.
Mean (SD) Peak Change-from-baseline Drug Effect Rating	Up to 5 hours	Subjective rating of drug effect (0-100) at peak effect: between 2 and 5 hours for oral dosing conditions and 0 and 2 hours for vaporized conditions. Higher numbers mean stronger drug effects, where 0 means no drug effect and 100 means extremely strong drug effect.

Countries

United States

Participant flow

Pre-assignment details

This was a within-subjects design, so all participants were exposed to all six conditions in a randomized order.

Participants by arm

Arm	Count
All Evaluable Study Completers Participants received oral (0, 10, 25mg) and vaporized (0mg, 5, 20mg) THC in a randomized within-subject crossover design	20
Total	20

Baseline characteristics

Characteristic	All Evaluable Study Completers
Age, Continuous	28.5 years STANDARD_DEVIATION 6.2
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	7 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) White	9 Participants
Region of Enrollment United States	20 Participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20
serious Total, serious adverse events	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20	0 / 20

Outcome results

Primary