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

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 Overview

• Status: Completed
• Conditions: Behavioral Pharmacology of Cannabis
• Intervention / Treatment: Drug: cannabis

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Oral Cannabis; Single acute administration of placebo cannabis baked into a brownie	Drug: cannabis; Cannabis will be self-administered by study participants; Other Names: marijuana
Experimental: Low-Dose Oral Cannabis; Single acute administration of cannabis containing 10mg THC baked into a brownie	Drug: cannabis; Cannabis will be self-administered by study participants; Other Names: marijuana
Experimental: High-Dose Oral Cannabis; Single acute administration of cannabis containing 25mg THC baked into a brownie	Drug: cannabis; Cannabis will be self-administered by study participants; Other Names: marijuana
Placebo Comparator: Placebo Vaporized Cannabis; Single acute administration of placebo cannabis via commercial vaporizer	Drug: cannabis; Cannabis will be self-administered by study participants; Other Names: marijuana
Experimental: Low-Dose Vaporized Cannabis; Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer	Drug: cannabis; Cannabis will be self-administered by study participants; Other Names: marijuana
Experimental: High-Dose Vaporized Cannabis; Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer	Drug: cannabis; Cannabis will be self-administered by study participants; Other Names: marijuana

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
11-hydroxy-tetrahydrocannabinol (11-OH-THC)	Quantitation of THC metabolite in blood (ng/ml)	8 hours
Tetrahydrocannabinolic Acid (THCCOOH)	Quantitation of THC metabolite in blood (ng/ml).	8 hours
Change in Heart Rate	Peak change from baseline	Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure
Mean (SD) Peak Change-from-baseline Drug Effect Rating	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.	Up to 5 hours
Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score	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".	8 hours
Peak Change in Blood Pressure	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.	8 hours post drug exposure

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA); RTI International; National Institute of Justice

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 11, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: IRB00122849; 2016-DN-BX-0193 (Other Grant/Funding Number: National Institute of Justice); R44DA046272-01A1 (U.S. NIH Grant/Contract); T32DA007209 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No