Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 9/19/2018 |
Start Date: | June 2014 |
End Date: | September 2014 |
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.
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.
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.
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