Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Johns Hopkins University
Sponsor:
Collaborators:
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
Information provided by (Responsible Party):
Ryan Vandrey, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02165176
First received: June 12, 2014
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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. The present study will evaluate 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). In addition, we will conduct subjective, behavioral, and cognitive performance assessments to evaluate the time course of the consequences of oral cannabis ingestion among study participants. The outcomes of the study will extend scientific knowledge about the behavioral pharmacology and toxicology of oral cannabis and can inform policies regarding clinical, workplace and roadside drug testing programs.


Condition Intervention Phase
Cannabis
Drug: Oral cannabis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabis

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Blood THC [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Urine THC-COOH [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Oral Fluid THC [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Subjective rating of "Drug Effect" [ Time Frame: baseline, immediately after exposure and 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post exposure ] [ Designated as safety issue: No ]
    Visual analog scale ratings of subjective intoxication


Estimated Enrollment: 24
Study Start Date: June 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10mg acute oral cannabis
10mg acute oral cannabis
Drug: Oral cannabis
Experimental: 25mg acute oral cannabis
25mg acute oral cannabis
Drug: Oral cannabis
Experimental: 50mg acute oral cannabis
50mg acute oral cannabis
Drug: Oral cannabis

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165176

Contacts
Contact: Eva Lenoir 410-550-1929 elenoir1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Contact: Eva Lenoir    410-550-1929    elenoir1@jhmi.edu   
Principal Investigator: Ryan Vandrey, PhD         
Sponsors and Collaborators
Johns Hopkins University
Substance Abuse and Mental Health Services Administration (SAMHSA)
RTI International
Investigators
Principal Investigator: Ryan Vandrey, PhD Johns Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: Ryan Vandrey, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02165176     History of Changes
Other Study ID Numbers: IRB00035394
Study First Received: June 12, 2014
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
cannabis
toxicology
intoxication

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014