Alcohol DrinkingNCT01620177

Effects of Inhaled Cannabis on Driving Performance

A study of Alcohol Drinking and Cannabis, run by Gary R Gaffney at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol. This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by… Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Alcohol Drinking, Cannabis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Mar 2014
Phase: Interventional
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 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult (age 21-55) men and women, based on medical and psychological evaluation
Currently valid unrestricted (except for vision correction) US driver's license
Licensed driver for at least the past two years
Drove at least 1300 miles in the past year, by self-report
Live within an 80 mile radius of NADS
Available for an overnight stay followed by a full-day study session for six sessions

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Must be considered a light or moderate drinker according to Quantity-Frequency-Variability Scale (QFV)
Cannabis use with a minimum frequency averaging at least one day per quarter and no more than three days a week during the three months prior to study entry
Peripheral veins suitable for repeated venipuncture and/or placement of an intravenous catheter
Systolic blood pressure within a clinically normal range (120 ± 30 mmHg) and -diastolic blood pressure of 80 ± 20 mmHg..
Good command of written and spoken English
Female subjects with reproductive potential must agree to use (and/or have their partner use) one (1) acceptable method of birth control beginning at the screening visit throughout the study (including intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control include the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, oral contraceptives or condoms. Abstinence is an alternative lifestyle and subjects practicing abstinence may be included in the study.

Who cannot join

Presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might influence driving performance (e.g., seizures, sleep apnea, narcolepsy, vertigo, chronic fatigue syndrome) or put the subject at increased risk of adverse events (e.g., cardiac arrhythmia, hypertension)
History of a clinically significant adverse event associated with cannabis or alcohol intoxication
Donation of more than 450 mL of blood within 14 days of study drug administration
If female, pregnant or nursing
Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 60 days preceding study enrollment
Currently taking drugs that are contraindicated for use with study drugs

Show all 11Show fewer

Requires any special equipment to aid in driving (ex. pedal extensions, hand brake or throttle, spinner wheel knobs or other non-standard equipment)
Significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening (SSQ). Subjects must have scores below the following values on the SSQ: Nausea < 21, Oculomotor <32, Disorientation < 15, and Total Score < 32.
Current alcohol or cannabis use disorder, as identified by the Alcohol Use Disorders Identification Test for alcohol or Cannabis Use Disorders Identification Test for cannabis.
History of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject from study participation
Prior participation in a driver impairment or distraction-related research study conducted at NADS that uses the same base drive.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Advanced Driving Simulator
Iowa City, Iowa, 52242

Other trials in United States

About this study

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol.

This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by building on prior driving situations used previously for testing the effects of alcohol on driving.

Read the detailed description

Individuals will be recruited who are currently users of cannabis and alcohol to participate in this study. They will undergo a physical exam at screening. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals \& Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis. After dosing, participants will have provide saliva samples and blood drawn periodically to check cannabis levels and will complete a driving simulation. After completing the drive, additional saliva samples and blood draws will occur and participants will be monitored until it is safe to transport home.

Conditions: Alcohol Drinking, Cannabis
Being tested: Alcohol(oral) and placebo, Cannabis(THC)(Inhaled) and Placebo
Keywords: Cannabis, Marijuana, Marihuana, Alcohol, Driving
Medical subject headings: Alcohol Drinking, Marijuana Abuse

What participants receive

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

Alcohol(oral) and placeboDrug
Also called Ethanol, Ethyl Alcohol
Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and PlaceboDrug
Also called Marihuana, Marijuana
Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC

Study groups in NCT01620177
Study group	Role	What they receive
0% THC with 0.065 g/dL BAC	Experimental	Not described Receives: Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo
2.5-3.5% THC with 0.065 g/dL BAC	Experimental	Not described Receives: Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo
6.0-7.5% THC and 0.065 g/dL BAC	Experimental	Not described Receives: Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo
2.5-3.5% THC with 0 g/dL BAC	Experimental	Not described Receives: Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo
6.0-7.5% THC with 0 g/dL BAC	Experimental	Not described Receives: Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo
0% THC with 0 g/dL BAC	Experimental	Not described Receives: Drug: Alcohol(oral) and placebo; Drug: Cannabis(THC)(Inhaled) and Placebo

What is being measured

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

Driving Performance
Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.
Measured: Through entire drive, 0.5-1.3 hr post cannabis administration.

Secondary outcomes (2)

THC Concentration in Plasma Sample
Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.
Measured: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration
THC Concentration Levels in Whole Blood
Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.
Measured: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis

Timeline

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

Jul 2012Mar 2014

First posted15 Jun 2012 (estimated)
Study startJul 2012
Primary completionMar 2014
Study completionMar 2014

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
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 N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01620177
Sponsor's protocol ID: 201109850
Status last verified: Apr 2018
First submitted: 4 Jun 2012
Last updated: 2 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving lateral control with and without alcohol. Drug Alcohol Depend. 2015 Sep 1;154:25-37. doi: 10.1016/j.drugalcdep.2015.06.015. Epub 2015 Jun 23.
PubMed 26144593
Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled Cannabis Vaporizer Administration: Blood and Plasma Cannabinoids with and without Alcohol. Clin Chem. 2015 Jun;61(6):850-69. doi: 10.1373/clinchem.2015.238287. Epub 2015 May 27.
PubMed 26019183
Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled vaporized cannabis, with and without alcohol: subjective effects and oral fluid-blood cannabinoid relationships. Drug Test Anal. 2016 Jul;8(7):690-701. doi: 10.1002/dta.1839. Epub 2015 Aug 10.
PubMed 26257143
Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving longitudinal control with and without alcohol. J Appl Toxicol. 2016 Nov;36(11):1418-29. doi: 10.1002/jat.3295. Epub 2016 Feb 18.
PubMed 26889769

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Inhaled Cannabis on Driving Performance
ClinicalTrials.gov ID: NCT01620177
Acronym / sponsor ID: 201109850
Conditions: Alcohol Drinking, Cannabis
Keywords: Cannabis, Marijuana, Marihuana, Alcohol, Driving
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Gary R GaffneyUniversity, hospital or other
Collaborators: National Highway Traffic Safety Administration (NHTSA), National Institute on Drug Abuse (NIDA)
Study start: Jul 2012
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 15 Jun 2012 (estimated)
Results: Posted 1 Jun 2017

Clinical summary

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

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
0% THC with 0.065 g/dL BAC	Experimental	Drug: Alcohol(oral) and placebo, Drug: Cannabis(THC)(Inhaled) and Placebo
2.5-3.5% THC with 0.065 g/dL BAC	Experimental	Drug: Alcohol(oral) and placebo, Drug: Cannabis(THC)(Inhaled) and Placebo
6.0-7.5% THC and 0.065 g/dL BAC	Experimental	Drug: Alcohol(oral) and placebo, Drug: Cannabis(THC)(Inhaled) and Placebo
2.5-3.5% THC with 0 g/dL BAC	Experimental	Drug: Alcohol(oral) and placebo, Drug: Cannabis(THC)(Inhaled) and Placebo
6.0-7.5% THC with 0 g/dL BAC	Experimental	Drug: Alcohol(oral) and placebo, Drug: Cannabis(THC)(Inhaled) and Placebo
0% THC with 0 g/dL BAC	Experimental	Drug: Alcohol(oral) and placebo, Drug: Cannabis(THC)(Inhaled) and Placebo

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy adult (age 21-55) men and women, based on medical and psychological evaluation
Currently valid unrestricted (except for vision correction) US driver's license
Licensed driver for at least the past two years
Drove at least 1300 miles in the past year, by self-report
Live within an 80 mile radius of NADS

Key exclusion criteria (11 listed)

Presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might influence driving performance (e.g., seizures, sleep apnea, narcolepsy, vertigo, chronic fatigue syndrome) or put the subject at increased risk of adverse events (e.g., cardiac arrhythmia, hypertension)
History of a clinically significant adverse event associated with cannabis or alcohol intoxication
Donation of more than 450 mL of blood within 14 days of study drug administration
If female, pregnant or nursing
Currently interested in or participating in drug abuse treatment, or participated in drug abuse treatment within 60 days preceding study enrollment

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
Alcohol(oral) and placeboAlso: Ethanol, Ethyl AlcoholSubjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive	Drug	0% THC with 0 g/dL BAC, 0% THC with 0.065 g/dL BAC, 2.5-3.5% THC with 0 g/dL BAC, 2.5-3.5% THC with 0.065 g/dL BAC, 6.0-7.5% THC and 0.065 g/dL BAC, 6.0-7.5% THC with 0 g/dL BAC
Cannabis(THC)(Inhaled) and PlaceboAlso: Marihuana, MarijuanaCannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC	Drug	0% THC with 0 g/dL BAC, 0% THC with 0.065 g/dL BAC, 2.5-3.5% THC with 0 g/dL BAC, 2.5-3.5% THC with 0.065 g/dL BAC, 6.0-7.5% THC and 0.065 g/dL BAC, 6.0-7.5% THC with 0 g/dL BAC

Primary outcome

Driving Performance
Time frame: Through entire drive, 0.5-1.3 hr post cannabis administration.
Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.

2 secondary outcomes

THC Concentration in Plasma Sample
Time frame: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration
THC Concentration Levels in Whole Blood
Time frame: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis

Results and safety

Results posted to the registry on 1 Jun 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
Overall Study	98	19

Primary outcome: Driving Performance

Time frame: Through entire drive, 0.5-1.3 hr post cannabis administration.. Number. Unit: cm

Measure	Cannabis - THC n = 18	Alcohol - BrAC (Breath Alcohol Concentration) n = 18	THC x BrAC n = 18
Value	0.26	0.42	0

Population analysed: One subject who was an extreme outlier across driving performance measures was excluded. Due to the variability in THC and BrAC levels across subjects and conditions, a regression model was used which combined all of the data.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0% THC With 0.065 g/dL BAC	0 of 29 (0%)	4 of 29 (13.8%)	Not reported
2.5-3.5% THC With 0.065 g/dL BAC	0 of 27 (0%)	4 of 27 (14.8%)	Not reported
6.0-7.5% THC and 0.065 g/dL BAC	0 of 24 (0%)	6 of 24 (25%)	Not reported
2.5-3.5% THC With 0 g/dL BAC	0 of 26 (0%)	0 of 26 (0%)	Not reported
6.0-7.5% THC With 0 g/dL BAC	0 of 31 (0%)	3 of 31 (9.7%)	Not reported
0% THC With 0 g/dL BAC	0 of 27 (0%)	0 of 27 (0%)	Not reported

Limitations and caveats (from the sponsor): This study examined only occasional users and the generalization to new or frequent cannabis users is unclear.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26144593Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving lateral control with and without alcohol. Drug Alcohol Depend. 2015 Sep 1;154:25-37. doi: 10.1016/j.drugalcdep.2015.06.015. Epub 2015 Jun 23.
Results publication: PubMed 26019183Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled Cannabis Vaporizer Administration: Blood and Plasma Cannabinoids with and without Alcohol. Clin Chem. 2015 Jun;61(6):850-69. doi: 10.1373/clinchem.2015.238287. Epub 2015 May 27.
Results publication: PubMed 26257143Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled vaporized cannabis, with and without alcohol: subjective effects and oral fluid-blood cannabinoid relationships. Drug Test Anal. 2016 Jul;8(7):690-701. doi: 10.1002/dta.1839. Epub 2015 Aug 10.
Results publication: PubMed 26889769Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving longitudinal control with and without alcohol. J Appl Toxicol. 2016 Nov;36(11):1418-29. doi: 10.1002/jat.3295. Epub 2016 Feb 18.

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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.

Gary G Gaffney, M.D. principal investigator

National Advanced Driving Simulator

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

Questions about this trial

What is this clinical trial studying?

A study of Alcohol Drinking and Cannabis, run by Gary R Gaffney 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?

The sponsor lists 12 inclusion and 11 exclusion criteria. 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 2 May 2018. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 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?

Driving Performance (time frame: Through entire drive, 0.5-1.3 hr post cannabis administration.). 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 NCT01620177, which also lists 4 linked publications.

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 2 May 2018.