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

NCT03122691 | Completed Phase 1 Results FDA Drug

• 4 other identifiers: IRB001228492016-DN-BX-0193R44DA046272-01A1T32DA007209
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral Pharmacology of Cannabis

Outcome Measures

Primary Outcomes (1)

• Tetrahydrocannabinol (THC) Concentration in Blood

  Quantitation of active drug (THC) in whole blood (ng/ml).

  8 hours

Secondary Outcomes (6)

• 11-hydroxy-tetrahydrocannabinol (11-OH-THC)

  8 hours

• Tetrahydrocannabinolic Acid (THCCOOH)

  8 hours

• Change in Heart Rate

  Baseline, 1, 2, 3, 4, 5, 6, 7, and 8 hours post drug exposure

• Mean (SD) Peak Change-from-baseline Drug Effect Rating

  Up to 5 hours

• Change From Baseline Behavioral Task Performance as Assessed by the DRUID App Score

  8 hours

Study Arms (6)

Placebo Oral Cannabis

PLACEBO COMPARATOR

Single acute administration of placebo cannabis baked into a brownie

Drug: cannabis

Low-Dose Oral Cannabis

EXPERIMENTAL

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

Drug: cannabis

High-Dose Oral Cannabis

EXPERIMENTAL

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

Drug: cannabis

Placebo Vaporized Cannabis

PLACEBO COMPARATOR

Single acute administration of placebo cannabis via commercial vaporizer

Drug: cannabis

Low-Dose Vaporized Cannabis

EXPERIMENTAL

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

Drug: cannabis

High-Dose Vaporized Cannabis

EXPERIMENTAL

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

Drug: cannabis

Interventions

cannabis DRUG

Cannabis will be self-administered by study participants

Also known as: marijuana

High-Dose Oral Cannabis; High-Dose Vaporized Cannabis; Low-Dose Oral Cannabis; Low-Dose Vaporized Cannabis; Placebo Oral Cannabis; Placebo Vaporized Cannabis

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• RTI International: collaborator
• U.S. Department of Justice: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Interventions

nabiximols

Results Point of Contact

• Title: Dr. Ryan Vandrey
• Organization: Johns Hopkins University School of Medicine

rvandrey@jhmi.edu

410-550-4036

Study Officials

• Ryan Vandrey, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled, double blind drug administration
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 21, 2017
• Study Start: May 1, 2018
• Primary Completion: June 11, 2019
• Study Completion: February 1, 2020
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)