Cannabis ToxicologyPhase 1NCT01798186

Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation

A Phase 1 study testing Cannabis in people with Cannabis Toxicology, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Cannabis Toxicology
What is being tested?: Cannabis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: May 2013to Aug 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224

Other trials in United States

About this study

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
Being tested: Cannabis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CannabisDrug
Also called Marijuana
Participants will be exposed to cannabis smoke present in ambient air

Study groups in NCT01798186
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.
Measured: 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
After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.
Measured: 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
Visual analog scale (0-100; not at all to extremely) of subjective "Drug Effect"
Measured: immediately post cannabis exposure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Aug 2013

First posted25 Feb 2013 (estimated)
Study startMay 2013
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cannabis ToxicologyStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: Between subjects Phase I study
Masking: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01798186
Sponsor's protocol ID: NA_00082269
Status last verified: Aug 2017
First submitted: 18 Feb 2013
Last updated: 3 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic and Pharmacodynamic Effects of Passive Cannabis Inhalation
ClinicalTrials.gov ID: NCT01798186
Acronym / sponsor ID: NA_00082269
Conditions: Cannabis Toxicology
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA), RTI International
Study start: May 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 25 Feb 2013 (estimated)
Results: Posted 3 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Between subjects Phase I study

Arm	Type	Receives
Cannabis 5% THC, No Ventilation	Experimental	Drug: CannabisParticipants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 5% THC and in a room with no ventilation.
Cannabis 11% THC, No Ventilation	Experimental	Drug: CannabisParticipants 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 11% THC, Ventilation	Experimental	Drug: CannabisParticipants in this condition will be passively exposed to second-hand cannabis smoke from cannabis containing 11% THC in a room with active ventilation.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CannabisAlso: MarijuanaParticipants will be exposed to cannabis smoke present in ambient air	Drug	Cannabis 11% THC, No Ventilation, Cannabis 11% THC, Ventilation, Cannabis 5% THC, No Ventilation

Primary outcome

Delta-9-tetrahydrocannabinol (THC) Cmax in Blood
Time frame: 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.

2 secondary outcomes

Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid
Time frame: 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
Time frame: immediately post cannabis exposure.

Results and safety

Results posted to the registry on 3 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cannabis 5% THC, no Ventilation	6	6
Cannabis 11% THC, no Ventilation	6	6
Cannabis 11% THC, Ventilated	6	6
Active Smokers	8	8

Primary outcome: Delta-9-tetrahydrocannabinol (THC) Cmax in Blood

Time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure. Mean (Standard Deviation). Unit: ng/mL

Measure	5% THC Cannabis, no Vent n = 6	11% THC Cannabis Smoke, no Vent n = 6	11% THC Cannabis, Vent n = 6
Value	1.4 (0.5)	3.07 (1.6)	0.5 (0.4)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5% THC Cannabis Smoke, no Ventilation	0 of 6 (0%)	0 of 6 (0%)	0 of 6
11% THC Cannabis Smoke, no Ventilation	0 of 6 (0%)	0 of 6 (0%)	0 of 6
11% THC Cannabis Smoke, Ventilation	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cannabis in people with Cannabis Toxicology, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delta-9-tetrahydrocannabinol (THC) Cmax in Blood (time frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01798186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.