Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
ClinicalTrials.gov Identifier:
NCT02177513
First received: June 24, 2014
Last updated: August 27, 2014
Last verified: May 2014
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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):

Primary Outcome Measures:
  • Cannabis' pharmacodynamic effects [ Time Frame: Multiple times daily ] [ Designated as safety issue: No ]
  • Cannabis' pharmacokinetic profiles [ Time Frame: Multiple times daily ] [ Designated as safety issue: No ]
  • Pharmacokinetic/Dynamic Modelling [ Time Frame: Once ] [ Designated as safety issue: No ]
  • Cannabis oral fluid cutoff evaluation [ Time Frame: Once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cannabinoid stability in dried blood [ Time Frame: Multiple times ] [ Designated as safety issue: No ]
  • Pharmacokinetic/Dynamic Modelling [ Time Frame: Multiple times ] [ Designated as safety issue: No ]
  • Cannabinoid stability in oral fluid [ Time Frame: Multiple times ] [ Designated as safety issue: No ]
  • Cannabis' effects on appetitive peptides [ Time Frame: Multiple times daily ] [ Designated as safety issue: No ]
  • Cannabis urine cutoff evaluation [ Time Frame: Once ] [ Designated as safety issue: No ]
  • Compare on-site oral fluid devices [ Time Frame: Once ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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: NCT02177513

Contacts
Contact: Marilyn Huestis, Ph.D. (410) 550-2711 marilyn.huestis@nih.hhs.gov

Locations
United States, Maryland
National Institute on Drug Abuse Recruiting
Baltimore, Maryland, United States, 21224
Contact: For more information contact Mathew's Media Group Recruiting    800-535-8254    researchstudies@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Marilyn Huestis, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
ClinicalTrials.gov Identifier: NCT02177513     History of Changes
Other Study ID Numbers: 999914135, 14-DA-N135
Study First Received: June 24, 2014
Last Updated: August 27, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cannabis
Pharmacodynamics
Marijuana
Cannabinoids
Vaporized

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

ClinicalTrials.gov processed this record on October 23, 2014