Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis

September 11, 2019 updated by: Johns Hopkins University
Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of smoked and vaporized cannabis. Careful analysis of different cannabis administration methods on these parameters is required to determine the level and duration of biological cannabinoid exposure and associated subjective, cardiovascular and cognitive effects. In the present study the investigators evaluated the detection of cannabinoids in whole blood, oral fluid, and urine, as well as the acute pharmacodynamics associated with smoked and vaporized cannabis among individuals who were not regular cannabis users. The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of smoked and vaporized cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have provided written informed consent
  2. Be between the ages of 18 and 45
  3. Be in good general health based on a physical examination, medical history, vital signs, 12-lead ECG and screening urine and blood tests
  4. Test negative for recent cannabis use in urine at the screening visit (confirmed by GC/MS laboratory test) and at clinic admission
  5. Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
  6. 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.
  7. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
  8. 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

Exclusion Criteria:

  1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
  2. 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.
  3. Use of an 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.
  4. 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.
  5. Use of hemp seeds or hemp oil in any form in the past 3 months.
  6. Use of dronabinol (Marinol) within the past 6 months.
  7. 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.
  8. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
  9. Abnormal EKG result that in the investigator's opinion is clinically significant.
  10. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0mg THC smoked cannabis
placebo smoked cannabis
Drug: Cannabis
Inhaled cannabis
EXPERIMENTAL: 10mg THC smoked cannabis
smoked cannabis containing 10mg THC
Drug: Cannabis
Inhaled cannabis
EXPERIMENTAL: 25mg THC smoked cannabis
smoked cannabis containing 25mg THC
Drug: Cannabis
Inhaled cannabis
EXPERIMENTAL: 0mg THC vaporized cannabis
placebo vaporized cannabis
Drug: Cannabis
Inhaled cannabis
EXPERIMENTAL: 10mg THC vaporized cannabis
vaporized cannabis containing 10mg THC
Drug: Cannabis
Inhaled cannabis
EXPERIMENTAL: 25mg THC vaporized cannabis
vaporized cannabis containing 25mg THC
Drug: Cannabis
Inhaled cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity of THC in blood
Time Frame: 8 hours post exposure
Quantitative measurement of blood THC by LC-MS/MS
8 hours post exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective rating of "Drug Effect"
Time Frame: 8 hours post exposure
Visual Analog Scale rating of subjective drug effect. Score ranges from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
8 hours post exposure
Psychomotor performance as assessed by Digit Symbol Substitution Task
Time Frame: 8 hours post exposure
Computerized version of Digit Symbol Substitution Task administered, total correct trials in 90-seconds measured
8 hours post exposure
Memory performance as assessed by Paced Auditory Serial Addition Task
Time Frame: 8 hours post exposure
Computerized version of Paced Auditory Serial Addition Task administered, total correct trials out of 90 recorded
8 hours post exposure
Performance on Divided Attention Task
Time Frame: 8 hours post exposure
Computerized Divided Attention Task administered, mean distance from central stimulus and number of targets correct out of 24 recorded
8 hours post exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Ryan Vandrey, PhD, Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2016

Primary Completion (ACTUAL)

January 17, 2017

Study Completion (ACTUAL)

January 17, 2017

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (ACTUAL)

September 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00035394

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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