Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis

NCT02165176 | Completed Phase 1

• 1 other identifier: IRB00035394
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis

Keywords

cannabis; toxicology; intoxication

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

10mg acute oral cannabis

EXPERIMENTAL

10mg acute oral cannabis

Drug: Oral cannabis

25mg acute oral cannabis

EXPERIMENTAL

25mg acute oral cannabis

Drug: Oral cannabis

50mg acute oral cannabis

EXPERIMENTAL

50mg acute oral cannabis

Drug: Oral cannabis

Interventions

Oral cannabis DRUG

10mg acute oral cannabis; 25mg acute oral cannabis; 50mg acute oral 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
• Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
• 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
• Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.
• 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
• Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).

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
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator
• RTI International: collaborator

Study Sites (1)

Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

US (1)