Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis

Few studies have been conducted to assess the pharmacokinetic and pharmacodynamic effects of orally consumed intact cannabis (e.g., cannabis-containing brownies). Careful analysis of oral cannabis dose effects 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 we evaluated the detection of cannabinoids in oral fluid, plasma, hair, and urine for up to 9 days following consumption of oral cannabis (10mg, 25mg, or 50mg THC). The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis administration and can inform policies regarding clinical, workplace and roadside drug testing programs.

Study Overview

• Status: Completed
• Conditions: Cannabis
• Intervention / Treatment: Drug: Oral cannabis

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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. Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
7. 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.
8. Have a body mass index (BMI) in the range of 19 to 36 kg/m2
9. Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
10. 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
11. Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).

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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 10mg acute oral cannabis	Drug: Oral cannabis
EXPERIMENTAL: 25mg acute oral cannabis	Drug: Oral cannabis
EXPERIMENTAL: 50mg acute oral cannabis	Drug: Oral cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood THC		baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Urine THC-COOH		Baseline and 1, 2, 3, 4, 4-6 hours, 6-8 hours, 8-10 hours, 10-12 hours and then every 4 hours up until the 130 hour post exposure time point
Oral Fluid THC		baseline and 0.2, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 22, 26, 30, 34, 46, 50, 54, 58, 70, 74, 78, 82, 94, 98, 102, 106, 118, 122, 126, and 130 hours post exposure
Subjective rating of "Drug Effect"	Visual analog scale ratings of subjective intoxication	baseline, immediately after exposure and 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post exposure

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: RTI International; Substance Abuse and Mental Health Services Administration (SAMHSA)
• Investigators: Principal Investigator: Ryan Vandrey, PhD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (ESTIMATE): June 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: cannabis; intoxication; toxicology
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: IRB00035394