Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

NCT01798186 | Completed Phase 1 Results

• 1 other identifier: NA_00082269
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Toxicology

Outcome Measures

Primary Outcomes (1)

• Delta-9-tetrahydrocannabinol (THC) Cmax in Blood

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

Secondary Outcomes (2)

• 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

• Subjective VAS Drug Effect

  immediately post cannabis exposure.

Study Arms (3)

Cannabis 5% THC, No Ventilation

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.

Drug: Cannabis

Cannabis 11% THC, No Ventilation

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.

Drug: Cannabis

Cannabis 11% THC, Ventilation

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.

Drug: Cannabis

Interventions

Cannabis DRUG

Participants will be exposed to cannabis smoke present in ambient air

Also known as: Marijuana

Cannabis 11% THC, No Ventilation; Cannabis 11% THC, Ventilation; Cannabis 5% THC, No Ventilation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator
• RTI International: collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Interventions

nabiximols

Results Point of Contact

• Title: Ryan Vandrey
• Organization: Johns Hopkins University

rvandrey@jhmi.edu

410-550-4036

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blind to the THC concentrations of cannabis being administered
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Between subjects Phase I study

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 25, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 3, 2017
• Results First Posted: August 3, 2017

Record last verified: 2017-08

Locations

US (1)