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Completed

NCT Number: NCT01798186

Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

This primary aim of this study is to assess the effects of passive (second-hand) inhalation of cannabis smoke on toxicological analysis of "native" oral fluid (saliva), urine and blood specimens. The results of this study will help inform the validity of oral fluid as a biomarker of cannabis exposure and to determine whether, and for how long, passive inhalation of cannabis smoke could result in a positive toxicology result.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Participants must:

  • 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
  • Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period
  • Be willing and able to abstain from use of any over-the-counter (OTC) or prescription drugs (other than birth control medications) after providing written informed consent and continuing until discharged from the study. OTC antacids may be taken up to 12 hours prior to dosing
  • Not be pregnant or nursing (if female), and using effective birth control. 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 33 kg/m2
  • Have head hair that is at least 4-6 cm (approximately two inches) in length on the back of the head.
  • Blood pressure at Screening Visit must not exceed a systolic blood pressure (SBP) of 140 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
  • Must not have history 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.
  • Cannot have been enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
  • No history of panic/anxiety reaction to extended periods of confinement in close quarters, smoke filled areas, or tight social situations.
  • No history of adverse reactions to cannabis exposure, whether via direct use or passive exposure.

Treatment and study plan

Cannabis

Drug

Participants will be exposed to cannabis smoke present in ambient air

Other names: Marijuana

Primary outcomes

  1. Delta-9-tetrahydrocannabinol (THC) Cmax in Blood

    Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure

    After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.

Secondary outcomes

  1. Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid

    Time frame: Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure

    After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.

  2. Subjective VAS Drug Effect

    Time frame: immediately post cannabis exposure.

    Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 25, 2013
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.