Trial record 4 of 23 for:    marijuana or cannabis and smoked | Exclude Unknown | United States

Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
ClinicalTrials.gov Identifier:
NCT01071616
First received: February 18, 2010
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

Background:

- Little research has been done on how different components of cannabis (marijuana) appear in oral fluid (i.e., saliva) after smoking. Cannabinoids have been well studied in whole blood, plasma, and urine after cannabis use, but less is known about how cannabinoids appear in oral fluid after controlled drug administration and how long these biomarkers last after use. In addition, the issue of stability of cannabinoids and their glucuronide metabolites is a controversial topic that is poorly understood. These data are critical to the interpretation of cannabinoid test results.

Objectives:

  • To collect whole blood, plasma, urine, and oral fluid specimens after smoking cannabis, to characterize the disposition and pharmacokinetics of cannabinoids in multiple biological matrices and to provide scientifically reliable data on the stability of cannabinoids and metabolites.
  • To test basic brain function and thinking processes after smoking cannabis.

Eligibility:

- Healthy volunteers between 18 and 45 years of age who use cannabis (an average of at least twice per month in the 3 months before the study.)

Design:

  • Participants may complete the single study session as outpatients, or they may spend the night prior to and/or following drug administration at the residential research unit in Baltimore, MD. Participants must provide a negative urine drug screen if they have not spent the evening prior to testing at the research unit.
  • Participants will provide whole blood, plasma, oral fluid, and urine samples, and will complete several tests of thinking and brain function at the start of the study.
  • Participants will smoke one standardized cannabis cigarette. Blood and oral fluid samples will be collected, and participants will repeat the tests of thinking and brain function multiple times after smoking.
  • Six hours after smoking the cigarette, participants must pass a neuromotor exam (testing balance and coordination) before they can be discharged from the study. Participants may be asked to stay overnight at the clinical center if there are concerns for their safety because of intoxication.

Condition Intervention Phase
Cannabis Use
Drug Abuse
Drug: Cannabis Cigarette
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Oral Fluid, Plasma and Whole Pharmacokinetics and Stability Following Smoked Cannabis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • THC and metabolite concentrations in whole blood, plasma, and oral fluid, stability of these concentrations over time, performance on neurocognitive tasks and subjective assessments.

Estimated Enrollment: 50
Study Start Date: January 2010
Study Completion Date: November 2013
Intervention Details:
    Drug: Cannabis Cigarette
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. 18 to 45 years of age;
    2. Cannabis use with a minimum frequency of at least twice per month during the three months prior to study entry for Part A or average frequency of cannabis smoking of less than twice per week (occasional cannabis smoker) in the past 3 months or at least four times per week (chronic frequent cannabis smoker) in the past 3 months for Part B;
    3. A positive urine cannabinoid screen if in the chronic frequent cannabis smoker group;
    4. Peripheral veins suitable for repeated venipuncture and/or placement of an intravenous catheter;
    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;

EXCLUSION CRITERIA:

  1. 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;
  2. History of a clinically significant adverse event associated with cannabis intoxication;
  3. Donation of more than 450 mL of blood within 30 days of study drug administration;
  4. If female, pregnant or nursing;
  5. Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 60 days preceding study enrollment.
  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: NCT01071616

Locations
United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224
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: NCT01071616     History of Changes
Other Study ID Numbers: 999910458, 10-DA-N458
Study First Received: February 18, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cannabinoids
Oral Fluid
Pharmacokinetics
Stability
Smoked Cannabis

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

ClinicalTrials.gov processed this record on August 26, 2014