Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

Phase 1

Completed

• Conditions: Cannabis Toxicology
• Interventions: Drug: Cannabis

• Registration Number: NCT01798186
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2017-04-17
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Results First Posted: 2017-08-03
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabis 11% THC, Ventilation	Cannabis	Participants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.
Cannabis 11% THC, No Ventilation	Cannabis	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.
Cannabis 5% THC, No Ventilation	Cannabis	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.

Primary Outcome Measures

Name	Time	Method
Delta-9-tetrahydrocannabinol (THC) Cmax in Blood	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 Outcome Measures

Name	Time	Method
Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid	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.
Subjective VAS Drug Effect	immediately post cannabis exposure.	Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"

Trial Locations

Locations (1)

Johns Hopkins Behavioral Pharmacology Research Unit; 🇺🇸 Baltimore, Maryland, United States