Completed

Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

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What is being tested

Cannabis

+ Cannabis

+ Cannabis

Drug
Who is being recruted

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: August 3, 2017
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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.

Principal SponsorJohns Hopkins University
Last updated: August 3, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 5% THC and in a room with no ventilation.

Group II

Experimental
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC and in a room with no ventilation.

Group III

Experimental
Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.

Study 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
CompletedOne Study Center