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

Johns Hopkins University

Status and phase: Completed; Phase 1

Conditions: Behavioral Pharmacology of Cannabis

Treatments: Drug: cannabis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03122691

2016-DN-BX-0193 (Other Grant/Funding Number)

T32DA007209 (U.S. NIH Grant/Contract)

IRB00122849

R44DA046272-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 6 patient groups, including a placebo group

Placebo Oral Cannabis

Placebo Comparator group

Description:

Single acute administration of placebo cannabis baked into a brownie

Treatment:

Drug: cannabis

Low-Dose Oral Cannabis

Experimental group

Description:

Single acute administration of cannabis containing 10mg THC baked into a brownie

Treatment:

Drug: cannabis

High-Dose Oral Cannabis

Experimental group

Description:

Single acute administration of cannabis containing 25mg THC baked into a brownie

Treatment:

Drug: cannabis

Placebo Vaporized Cannabis

Placebo Comparator group

Description:

Single acute administration of placebo cannabis via commercial vaporizer

Treatment:

Drug: cannabis

Low-Dose Vaporized Cannabis

Experimental group

Description:

Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer

Treatment:

Drug: cannabis

High-Dose Vaporized Cannabis

Experimental group

Description:

Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer

Treatment:

Drug: cannabis