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Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02177513
First Posted: June 27, 2014
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
  Purpose

Background:

- Marijuana (cannabis) is an illegal drug. Researchers want to study people s reactions, attention, and behavior after they take marijuana in different ways. They want to learn better ways to detect drugs in a person s body They also want to know how long marijuana can be found in blood, urine, saliva, and breath.

Objectives:

- To learn how people respond to delta-9-tetrahydrocannabinol (THC, a marijuana component) and how their bodies handle it after it is given in different ways.

Eligibility:

- Adults age 18 50 who use marijuana.

Design:

  • Participants are screened under another NIDA protocol.
  • This study involves up to 6 visits to NIDA.
  • At the first visit, participants will practice the tasks and tests they will do at their dosing sessions. They will learn how to give breath and saliva samples.
  • Dosing sessions 1 4 will last 3 5 days each. All participants will be admitted to a research clinic the night before these sessions. Some participants can stay at the clinic and some must go home between sessions.
  • At each session, participants will eat a brownie with placebo or marijuana. Then they will smoke a placebo or marijuana cigarette. Some will inhale placebo or marijuana after it is vaporized.
  • Throughout the sessions:
  • Participants will give urine, saliva, and breath samples. Their blood will be taken with a tube in a vein and finger pricks. Their vital signs will be checked.
  • Participants will answer questionnaires and take thinking tests. They will also take tests that assess eye movement, balance, and time estimation.
  • Participants may have a 5th dosing session. They will eat a marijuana brownie and have the above tests and samples.

Condition Intervention Phase
Cannabis Use Drug: Placebo + Placebo Drug: Oral Cannabis + Placebo Drug: Placebo + Inhaled Cannabis Drug: Placebo + Smoked Cannabis Drug: 6.9% cannabis oral Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):

Primary Outcome Measures:
  • Cannabis' pharmacodynamic effects [ Time Frame: Multiple times daily ]
  • Cannabis' pharmacokinetic profiles [ Time Frame: Multiple times daily ]
  • Pharmacokinetic/Dynamic Modelling [ Time Frame: Once ]
  • Cannabis oral fluid cutoff evaluation [ Time Frame: Once ]

Secondary Outcome Measures:
  • Cannabinoid stability in dried blood [ Time Frame: Multiple times ]
  • Pharmacokinetic/Dynamic Modelling [ Time Frame: Multiple times ]
  • Cannabinoid stability in oral fluid [ Time Frame: Multiple times ]
  • Cannabis' effects on appetitive peptides [ Time Frame: Multiple times daily ]
  • Cannabis urine cutoff evaluation [ Time Frame: Once ]
  • Compare on-site oral fluid devices [ Time Frame: Once ]

Estimated Enrollment: 80
Study Start Date: June 14, 2014
Study Completion Date: April 27, 2016
Primary Completion Date: April 27, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Placebo + Smoked Cannabis
Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking the equivalent of one active (6.9% THC) cigarette.
Active Comparator: 2 Drug: Placebo + Inhaled Cannabis
Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette
Active Comparator: 3 Drug: Oral Cannabis + Placebo
Participants will consume a brownie containing the equivalent of one active (6.9% THC) cannabis cigarette followed by either smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.
Placebo Comparator: 4 Drug: Placebo + Placebo
Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.
Active Comparator: 5 Drug: 6.9% cannabis oral
Participants will consume a brownie containing the equivalent of one active (6.91% THC) cannabis cigarette.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. 18 to 50 years of age;
    2. Cannabis consumption with a minimum frequency of at least twice per month during the three months prior to the study and average frequency of cannabis smoking of less than three times per week (occasional cannabis smoker) in the past 3 months or at least an average of five times per week (frequent cannabis smoker) in the past 3 months;
    3. A positive urine cannabinoid screen if in the frequent cannabis smoker group;
    4. Peripheral veins suitable for repeated venipuncture and/or placement of an intravenous catheter, as assessed by a physician s assistant, nurse, or physician;
    5. Blood pressure (BP) and heart rate (HR) at or below the following values while sitting after five min rest: systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg, heart rate (HR) 100 bpm;
    6. ECG and three-minute rhythm strip without clinically relevant abnormalities;
    7. Women with reproductive potential must use a medically acceptable form of contraception for the duration of the study. Medically acceptable forms of contraception include: oral contraceptive, intrauterine device (IUD), depot hormonal preparation (ring, injection implant), or a barrier method of contraception such as a diaphragm, sponge with spermicide, or a condom. Abstinence is an alternative lifestyle and subjects practicing abstinence may be included in the study.
    8. Must be able to safely suspend use of CNS depressant, anticholinergic, and/or sympathomimetic medications before study dosing. Length of medication suspension will be equal to 3 half-lives of the medication in use.

EXCLUSION CRITERIA:

  1. Current physical dependence on any drug other than cannabis, caffeine, or nicotine;
  2. Currently using cannabis for medical purposes under the explicit recommendation of a physician providing medical care;
  3. History or presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests , that might put the subject at increased risk of adverse events such as history of psychotic disorder, clinically significant mood and/or anxiety disorder, diabetes, liver, renal or cardiovascular disease;
  4. Liver enzymes greater than or equal to 2 times upper normal limit and/or clinical signs/symptoms consistent with liver disease including but not limited to nausea, vomiting, jaundice, itching, abdominal pain, and swelling;
  5. History of clinically significant adverse events associated with cannabis intoxication such as severe anxiety and panic, paranoia and psychosis, sustained tachycardia, or severe hypotension;
  6. Donation of more than 450 mL blood within 8 weeks of study treatment phase;
  7. Hemoglobin less than 12.0 g/dL and/or clinical signs/symptoms consistent with anemia including but not limited to fatigue, tachycardia, shortness of breath, and dizziness;
  8. If female, pregnant or nursing;
  9. Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 90 days preceding study enrollment;
  10. History of food allergy or sensitivity to gluten, dairy, egg, soy, and/or chocolate.
  11. Any form of color blindness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177513


Locations
United States, Maryland
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Marilyn Huestis, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT02177513     History of Changes
Other Study ID Numbers: 999914135
14-DA-N135
First Submitted: June 24, 2014
First Posted: June 27, 2014
Last Update Posted: July 2, 2017
Last Verified: April 27, 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Cannabis
Pharmacodynamics
Marijuana
Cannabinoids
Vaporized

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