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

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ClinicalTrials.gov Identifier: NCT03122691
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
RTI International
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Behavioral Pharmacology of Cannabis Drug: cannabis Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Placebo controlled, double blind drug administration
Primary Purpose: Basic Science
Official Title: Differences in Cannabis Impairment and Its Measurement Due to Route of Administration
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: marijuana




Primary Outcome Measures :
  1. Tetrahydrocannabinol (THC) [ Time Frame: 8 hours ]
    quantitation of active drug in blood


Secondary Outcome Measures :
  1. 11-hydroxy-tetrahydrocannabinol (11-OH-THC) [ Time Frame: 8 hours ]
    quantitation of THC metabolite in blood

  2. Tetrahydrocannabinolic acid (THCCOOH) [ Time Frame: 8 hours ]
    quantitation of THC metabolite in blood

  3. Vitals [ Time Frame: 8 hours ]
    Heart rate and blood pressure

  4. Drug effect rating [ Time Frame: 8 hours ]
    Subjective rating of drug effects

  5. Behavioral task performance as assessed by the DRUID App Score [ Time Frame: 8 hours ]
    Composite score on the DRUID App, a measure of behavioral task performance (range 0-100) where lower scores indicate better performance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122691


Contacts
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Contact: Erin Martin 410-550-2695 emarti82@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21231
Contact: Ryan Vandrey         
Sponsors and Collaborators
Johns Hopkins University
RTI International
Investigators
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Principal Investigator: Ryan Vandrey, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03122691     History of Changes
Other Study ID Numbers: IRB00122849
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders