Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics and Pharmacological Effects of a Standardized Cannabis Preparation

NCT04841993

Cannabis Use Healthy Subjects

COMPLETED PHASE1

Cannabidiol Effects on Cardiovascular System and Exercise Responses

NCT05232123

Healthy

WITHDRAWN EARLY_PHASE1

Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers

NCT04461756

Healthy Volonteers

COMPLETED PHASE1

The Pharmacokinetics of Single Dose Oral Tetrahydrocannabinol and Cannabidiol

NCT05742724

Cannabis Chronic Kidney Diseases Dialysis

ACTIVE_NOT_RECRUITING PHASE1

Synthetic THC And Blood Pressure

NCT07231965

Blood Pressure

NOT_YET_RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cannabis Toxicology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between subjects Phase I study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Participants are blind to the THC concentrations of cannabis being administered

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cannabis 5% THC, No Ventilation

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 Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Participants will be exposed to cannabis smoke present in ambient air

Cannabis 11% THC, No Ventilation

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 Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Participants will be exposed to cannabis smoke present in ambient air

Cannabis 11% THC, Ventilation

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

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Participants will be exposed to cannabis smoke present in ambient air

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabis

Participants will be exposed to cannabis smoke present in ambient air

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Marijuana

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes