Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
Cannabis
+ Cannabis
+ Cannabis
Diagnostic Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, United StatesOpen Johns Hopkins Behavioral Pharmacology Research Unit in Google Maps