Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis

• ClinicalTrials.gov Identifier: NCT03676166
• Recruitment Status: Completed
• First Posted: September 18, 2018
• Last Update Posted: September 13, 2019
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cannabis	Drug: Cannabis	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis
• Actual Study Start Date: June 16, 2016
• Actual Primary Completion Date: January 17, 2017
• Actual Study Completion Date: January 17, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Quantity of THC in blood [ Time Frame: 8 hours post exposure ]
   Quantitative measurement of blood THC by LC-MS/MS

Secondary Outcome Measures :

1. 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.
2. 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
3. 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
4. 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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Spindle TR, Cone EJ, Schlienz NJ, Mitchell JM, Bigelow GE, Flegel R, Hayes E, Vandrey R. Acute Effects of Smoked and Vaporized Cannabis in Healthy Adults Who Infrequently Use Cannabis: A Crossover Trial. JAMA Netw Open. 2018 Nov 2;1(7):e184841. doi: 10.1001/jamanetworkopen.2018.4841. Erratum in: JAMA Netw Open. 2018 Dec 7;1(8):e187241.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03676166
• Other Study ID Numbers: IRB_00035394
• First Posted: September 18, 2018
• Last Update Posted: September 13, 2019
• Last Verified: September 2018

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

Keywords provided by Johns Hopkins University:

Cannabis; Toxicology; Intoxication

Additional relevant MeSH terms:

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders