Pharmacokinetic and Pharmacodynamic Effects of Smoked and Vaporized Cannabis

NCT03676166 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB_00035394
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis

Keywords

Cannabis; Toxicology; Intoxication

Outcome Measures

Primary Outcomes (1)

• Quantity of THC in blood

  Quantitative measurement of blood THC by LC-MS/MS

  8 hours post exposure

Secondary Outcomes (4)

• Subjective rating of "Drug Effect"

  8 hours post exposure

• Psychomotor performance as assessed by Digit Symbol Substitution Task

  8 hours post exposure

• Memory performance as assessed by Paced Auditory Serial Addition Task

  8 hours post exposure

• Performance on Divided Attention Task

  8 hours post exposure

Study Arms (6)

0mg THC smoked cannabis

EXPERIMENTAL

placebo smoked cannabis

Drug: Cannabis

10mg THC smoked cannabis

EXPERIMENTAL

smoked cannabis containing 10mg THC

Drug: Cannabis

25mg THC smoked cannabis

EXPERIMENTAL

smoked cannabis containing 25mg THC

Drug: Cannabis

0mg THC vaporized cannabis

EXPERIMENTAL

placebo vaporized cannabis

Drug: Cannabis

10mg THC vaporized cannabis

EXPERIMENTAL

vaporized cannabis containing 10mg THC

Drug: Cannabis

25mg THC vaporized cannabis

EXPERIMENTAL

vaporized cannabis containing 25mg THC

Drug: Cannabis

Interventions

Cannabis DRUG

Inhaled cannabis

0mg THC smoked cannabis; 0mg THC vaporized cannabis; 10mg THC smoked cannabis; 10mg THC vaporized cannabis; 25mg THC smoked cannabis; 25mg THC vaporized cannabis

Eligibility Criteria

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

You may qualify if:

• Have provided written informed consent
• Be between the ages of 18 and 45
• 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 GC/MS laboratory test) and at clinic admission
• Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic admission
• 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

You may not qualify if:

• Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
• 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 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.
• 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

Study Sites (1)

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 30646391 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Study Officials

• Ryan Vandrey, PhD

  Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 18, 2018
• Study Start: June 16, 2016
• Primary Completion: January 17, 2017
• Study Completion: January 17, 2017
• Last Updated: September 13, 2019

Record last verified: 2018-09

Locations

US (1)