Driving ImpairedPhase 1/2NCT05273658
Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests
A Phase 1/2 study testing Cannabis and Alcohol in people with Driving Impaired and Alcohol Intoxication, run by University of California, San Diego.
Trial summary
The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Impaired, Alcohol Intoxication, Driving Under the Influence
- What is being tested?
- Cannabis and Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Aged 21 to 55
- Must be a licensed driver and driven a minimum of 1,000 miles in the past year
- Experience with cannabis and alcohol
Who cannot join
- At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
- Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
- Positive pregnancy test
- A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
- Unwilling to refrain from driving or operating heavy machinery after consuming study medication.
About this study
The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and tetrahydrocannabinol (THC), 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo. Cannabis inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid/saliva, breath) over the subsequent 4 hours after ingestion. The purpose of this study is to determine (1) the impact of Δ9-THC on driving performance with and without concurrent alcohol ingestion (2) the duration of driving impairment in terms of hours from initial use, (3) the relationship between performance on the DRE measures and cannabis/alcohol ingestion, and 4) if saliva or expired air can serve as a useful adjunct to the field for blood sampling.
Read the detailed description
Driving under the influence of alcohol and cannabis presents significant safety risks. In the real world, impairment is usually determined via the standardized field sobriety tests (SFSTs), a series of psychophysiological tests conducted by law enforcement officers. These include the Horizontal Gaze Nystagmus (HGN; eye movements when following the officer's fingers in space), Walk and Turn (WAT; walking nine steps, turning, and walking back), and One Leg Stand (OLS; holding each leg in the air for a designated period of time).
Despite a vast literature documenting impaired driving behavior due to alcohol consumption, much less is known regarding driving under the influence of cannabis, and even less about how the combination of alcohol and cannabis may affect driving behavior. This study will examine whether either, or both, conditions significantly impact performance in a driving simulator, on cognitive measures, and during the comprehensive Drug Recognition Expert evaluations (which includes SFSTs, as well as additional measures).
Alcohol studies. Higher blood alcohol levels (BACs) have been consistently related to impaired driving. BACs greater than .08% have been associated with 5.5 times higher crash risk compared to those without alcohol or drugs. In terms of detecting alcohol-related impairment, SFSTs have consistently been shown to be predictors of a blood alcohol concentration of .08%.
Cannabis studies. Several studies suggest higher doses of whole-blood or plasma delta-9 tetrahydrocannabinol (THC) concentration are associated with increased crash risk and crash culpability. However, attempts to define a cut-off point for blood THC levels have proven to be challenging. Unlike alcohol, for which a level can be reasonably measured using a breathalyzer (and confirmed with a blood test), detection of a cut-off point for intoxication related to THC concentration has eluded scientific verification. Most recently, we did not find any correlation between blood THC concentrations and driving performance. To date, the relationship between SFSTs and cannabis use/impairment have been mixed across studies.
Cannabis and Alcohol. There have been a limited number of studies examining the combination of cannabis and alcohol on driving and/or field sobriety test performance.
With respect to subjective effects, alcohol has been found to potentiate the duration of the cannabis effects, with subjective effects being longer in the cannabis-alcohol combinations compared to either drug alone. Participants also reported more effects after alcohol and cannabis were combined, compared to alcohol alone. Another study found that alcohol pre-treatment decreased the latency to the cannabis effects, and increased the duration of the effects. It has also been hypothesized that frequent cannabis users may develop cross-tolerance to the effects of alcohol.
Some studies have found SFSTs to be only mildly sensitive to cannabis effects in heavy cannabis users, but sensitive to doses of alcohol.
There have also been suggestions that the concurrent presence of cannabis and alcohol may result in increased THC and 11-Hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) levels, possibly by affecting initial absorption (resulting in higher concentrations immediately post-inhalation; the overall area under the curve (AUC) does not differ based upon alcohol ingestion), although the possible mechanisms for this - such as increased cardiac output facilitating absorption via increased pulmonary capillary flow, or less cannabis self-titration after alcohol intake - are as yet unresolved.
Research Design
One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and THC, 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo.
Cannabis, acquired from the National Institute on Drug Abuse Drug Supply Program, will be inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid [OF] saliva, breath) over the subsequent 4 hours after ingestion.
Driving simulations will be conducted using a 3-monitor, fully-interactive STISIM (Systems Technology Inc. Simulator) console system. The simulations will be similar to those used in our recently completed study of 191 cannabis users.
Drug Recognition Expert (DRE) evaluations will be conducted by DREs, and will consist of 1) Preliminary Examination and First Pulse; 2) Eye Examinations: Horizontal gaze nystagmus (HGN); Vertical gaze nystagmus (VGN); Lack of convergence (LOC); 3) Divided Attention Psychophysical Tests: Modified Romberg balance; Walk and turn; One leg stand; Finger to nose; 4) Vital Signs and Second Pulse (Blood pressure, temperature, pulse); 5) Dark Room Examinations (pupillometer): Assess for dilation or constriction; pupillary response to light; 6) Examination for Muscle Tone; 7) Third Pulse.
Cannabinoids levels in blood, oral fluid, and breath will be determined via liquid chromatography with tandem mass spectrometry (LC-MS-MS).
The results of this study will further advance the understanding of the impact of acute cannabis and alcohol administration on driving performance, as well as the best methods for detecting driving under the influence of these substances.
- Conditions
- Driving Impaired, Alcohol Intoxication, Driving Under the Influence, Cannabis Intoxication
- Being tested
- Cannabis, Alcohol
- Keywords
- Cannabis, Alcohol, Driving
- Medical subject headings
- Alcoholic Intoxication, Driving Under the Influence, Marijuana Abuse
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 smoke a cannabis cigarette ad libitum as per their usual routine
AlcoholDrug
Participants will ingest alcohol to achieve the target breath alcohol level
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo cannabis and placebo alcohol Receives: Drug: Cannabis; Drug: Alcohol |
| Cannabis, No alcohol | Experimental | 18.16% THC, placebo alcohol Receives: Drug: Cannabis; Drug: Alcohol |
| Cannabis, Low dose alcohol | Experimental | 18.16% THC, .07 breath alcohol concentration Receives: Drug: Cannabis; Drug: Alcohol |
| Placebo cannabis, High dose alcohol | Experimental | <.1% THC, .10 Breath alcohol concentration Receives: Drug: Cannabis; Drug: Alcohol |
| Placebo cannabis, Low dose alcohol | Experimental | <.1% THC, .07 breath alcohol concentration Receives: Drug: Cannabis; Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Drive Score
The Composite Drive Score (CDS) is a z-score comprised of key variables from the simulator tasks (SDLP, speed deviation, and task accuracy during the modified Surrogate Reference Task (mSuRT); coherence from the car following task). This outcome reflects the change in CDS from the pre-smoking assessment, at each timepoint.
The z-score indicates the number of standard deviations away from the mean from the baseline performance for the entire group. A Z-score of 0 is equal to the mean of a reference population (in this case the pre-smoking performance for the entire group).
Higher z-scores at each timepoint indicate worse performance (variables that went in the opposite direction were reflected in order to have all variables have the same direction). When examining the change in Composite Drive Score (this outcome variable), a higher score indicates a decline in performance (e.g., Time 2 minus Time1).
Measured: Participants are assessed pre-smoking/drinking, and then approximately 30 minutes, 1 hour 30 minutes, and 3 hours 30 minutes post-smoking
Secondary outcomes (4)
DRE Impairment
DRE officers' determination regarding participant impairment
Measured: Approximately 1.5 hours and 2.5 hours after alcohol/cannabis administration
Whole blood THC concentration
Whole blood THC concentrations determine via LC-MS-MS
Measured: Approximately 30 minutes after alcohol/cannabis administration
Oral Fluid THC concentration
Oral fluid THC concentrations determine via LC-MS-MS
Measured: Approximately 30 minutes after alcohol/cannabis administration
Breath THC concentration
Breath THC concentrations determine via LC-MS-MS
Measured: Approximately 30 minutes after alcohol/cannabis administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study startAug 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Termination of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Driving ImpairedStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to smoke a cannabis cigarette containing placebo (.02%) or 18.1% THC, and consume alcohol to achieve a breath alcohol level of .07, .10, or 0.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas D. Marcotte, PhD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273658
- Sponsor's protocol ID
- 192048
- Status last verified
- Sep 2023
- First submitted
- 28 Feb 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Movig KL, Mathijssen MP, Nagel PH, van Egmond T, de Gier JJ, Leufkens HG, Egberts AC. Psychoactive substance use and the risk of motor vehicle accidents. Accid Anal Prev. 2004 Jul;36(4):631-6. doi: 10.1016/S0001-4575(03)00084-8.
PubMed 15094417Stuster J. Validation of the standardized field sobriety test battery at 0.08% blood alcohol concentration. Hum Factors. 2006 Fall;48(3):608-14. doi: 10.1518/001872006778606895.
PubMed 17063973Grotenhermen F, Leson G, Berghaus G, Drummer OH, Kruger HP, Longo M, Moskowitz H, Perrine B, Ramaekers JG, Smiley A, Tunbridge R. Developing limits for driving under cannabis. Addiction. 2007 Dec;102(12):1910-7. doi: 10.1111/j.1360-0443.2007.02009.x. Epub 2007 Oct 4.
PubMed 17916224Hartman 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 26257143Ramaekers JG, Theunissen EL, de Brouwer M, Toennes SW, Moeller MR, Kauert G. Tolerance and cross-tolerance to neurocognitive effects of THC and alcohol in heavy cannabis users. Psychopharmacology (Berl). 2011 Mar;214(2):391-401. doi: 10.1007/s00213-010-2042-1. Epub 2010 Oct 30.
PubMed 21049267Hartman 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 26144593Hoffman MA, Hubbard JA, Sobolesky PM, Smith BE, Suhandynata RT, Sanford S, Sones EG, Ellis S, Umlauf A, Huestis MA, Grelotti DJ, Grant I, Marcotte TD, Fitzgerald RL. Blood and Oral Fluid Cannabinoid Profiles of Frequent and Occasional Cannabis Smokers. J Anal Toxicol. 2021 Sep 17;45(8):851-862. doi: 10.1093/jat/bkab078.
PubMed 34173005Hubbard JA, Smith BE, Sobolesky PM, Kim S, Hoffman MA, Stone J, Huestis MA, Grelotti DJ, Grant I, Marcotte TD, Fitzgerald RL. Validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) method to detect cannabinoids in whole blood and breath. Clin Chem Lab Med. 2020 Apr 28;58(5):673-681. doi: 10.1515/cclm-2019-0600.
PubMed 31527291
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests
- ClinicalTrials.gov ID
- NCT05273658
- Acronym / sponsor ID
- 192048
- Conditions
- Driving Impaired, Alcohol Intoxication, Driving Under the Influence, Cannabis Intoxication
- Keywords
- Cannabis, Alcohol, Driving
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Termination of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and tetrahydrocannabinol (THC), 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo. Cannabis inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid/saliva, breath) over the subsequent 4 hours after ingestion. The purpose of this study is to determine (1) the impact of Δ9-THC on driving performance with and without concurrent alcohol ingestion (2) the duration of driving impairment in terms of hours from initial use, (3) the relationship between performance on the DRE measures and cannabis/alcohol ingestion, and 4) if saliva or expired air can serve as a useful adjunct to the field for blood sampling.
Detailed description
Driving under the influence of alcohol and cannabis presents significant safety risks. In the real world, impairment is usually determined via the standardized field sobriety tests (SFSTs), a series of psychophysiological tests conducted by law enforcement officers. These include the Horizontal Gaze Nystagmus (HGN; eye movements when following the officer's fingers in space), Walk and Turn (WAT; walking nine steps, turning, and walking back), and One Leg Stand (OLS; holding each leg in the air for a designated period of time).
Despite a vast literature documenting impaired driving behavior due to alcohol consumption, much less is known regarding driving under the influence of cannabis, and even less about how the combination of alcohol and cannabis may affect driving behavior. This study will examine whether either, or both, conditions significantly impact performance in a driving simulator, on cognitive measures, and during the comprehensive Drug Recognition Expert evaluations (which includes SFSTs, as well as additional measures).
Alcohol studies. Higher blood alcohol levels (BACs) have been consistently related to impaired driving. BACs greater than .08% have been associated with 5.5 times higher crash risk compared to those without alcohol or drugs. In terms of detecting alcohol-related impairment, SFSTs have consistently been shown to be predictors of a blood alcohol concentration of .08%.
Cannabis studies. Several studies suggest higher doses of whole-blood or plasma delta-9 tetrahydrocannabinol (THC) concentration are associated with increased crash risk and crash culpability. However, attempts to define a cut-off point for blood THC levels have proven to be challenging. Unlike alcohol, for which a level can be reasonably measured using a breathalyzer (and confirmed with a blood test), detection of a cut-off point for intoxication related to THC concentration has eluded scientific verification. Most recently, we did not find any correlation between blood THC concentrations and driving performance. To date, the relationship between SFSTs and cannabis use/impairment have been mixed across studies.
Cannabis and Alcohol. There have been a limited number of studies examining the combination of cannabis and alcohol on driving and/or field sobriety test performance.
With respect to subjective effects, alcohol has been found to potentiate the duration of the cannabis effects, with subjective effects being longer in the cannabis-alcohol combinations compared to either drug alone. Participants also reported more effects after alcohol and cannabis were combined, compared to alcohol alone. Another study found that alcohol pre-treatment decreased the latency to the cannabis effects, and increased the duration of the effects. It has also been hypothesized that frequent cannabis users may develop cross-tolerance to the effects of alcohol.
Some studies have found SFSTs to be only mildly sensitive to cannabis effects in heavy cannabis users, but sensitive to doses of alcohol.
There have also been suggestions that the concurrent presence of cannabis and alcohol may result in increased THC and 11-Hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC) levels, possibly by affecting initial absorption (resulting in higher concentrations immediately post-inhalation; the overall area under the curve (AUC) does not differ based upon alcohol ingestion), although the possible mechanisms for this - such as increased cardiac output facilitating absorption via increased pulmonary capillary flow, or less cannabis self-titration after alcohol intake - are as yet unresolved.
Research Design
One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and THC, 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo.
Cannabis, acquired from the National Institute on Drug Abuse Drug Supply Program, will be inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid [OF] saliva, breath) over the subsequent 4 hours after ingestion.
Driving simulations will be conducted using a 3-monitor, fully-interactive STISIM (Systems Technology Inc. Simulator) console system. The simulations will be similar to those used in our recently completed study of 191 cannabis users.
Drug Recognition Expert (DRE) evaluations will be conducted by DREs, and will consist of 1) Preliminary Examination and First Pulse; 2) Eye Examinations: Horizontal gaze nystagmus (HGN); Vertical gaze nystagmus (VGN); Lack of convergence (LOC); 3) Divided Attention Psychophysical Tests: Modified Romberg balance; Walk and turn; One leg stand; Finger to nose; 4) Vital Signs and Second Pulse (Blood pressure, temperature, pulse); 5) Dark Room Examinations (pupillometer): Assess for dilation or constriction; pupillary response to light; 6) Examination for Muscle Tone; 7) Third Pulse.
Cannabinoids levels in blood, oral fluid, and breath will be determined via liquid chromatography with tandem mass spectrometry (LC-MS-MS).
The results of this study will further advance the understanding of the impact of acute cannabis and alcohol administration on driving performance, as well as the best methods for detecting driving under the influence of these substances.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be randomized to smoke a cannabis cigarette containing placebo (.02%) or 18.1% THC, and consume alcohol to achieve a breath alcohol level of .07, .10, or 0.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cannabis, Drug: AlcoholPlacebo cannabis and placebo alcohol |
| Cannabis, No alcohol | Experimental | Drug: Cannabis, Drug: Alcohol18.16% THC, placebo alcohol |
| Cannabis, Low dose alcohol | Experimental | Drug: Cannabis, Drug: Alcohol18.16% THC, .07 breath alcohol concentration |
| Placebo cannabis, High dose alcohol | Experimental | Drug: Cannabis, Drug: Alcohol<.1% THC, .10 Breath alcohol concentration |
| Placebo cannabis, Low dose alcohol | Experimental | Drug: Cannabis, Drug: Alcohol<.1% THC, .07 breath alcohol concentration |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 21 to 55
- Must be a licensed driver and driven a minimum of 1,000 miles in the past year
- Experience with cannabis and alcohol
Key exclusion criteria (5 listed)
- At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
- Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
- Positive pregnancy test
- A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
- Unwilling to refrain from driving or operating heavy machinery after consuming study medication.
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 smoke a cannabis cigarette ad libitum as per their usual routine | Drug | Cannabis, Low dose alcohol, Cannabis, No alcohol, Placebo, Placebo cannabis, High dose alcohol, Placebo cannabis, Low dose alcohol |
| AlcoholParticipants will ingest alcohol to achieve the target breath alcohol level | Drug | Cannabis, Low dose alcohol, Cannabis, No alcohol, Placebo, Placebo cannabis, High dose alcohol, Placebo cannabis, Low dose alcohol |
Primary outcome
Composite Drive Score
Time frame: Participants are assessed pre-smoking/drinking, and then approximately 30 minutes, 1 hour 30 minutes, and 3 hours 30 minutes post-smoking
The Composite Drive Score (CDS) is a z-score comprised of key variables from the simulator tasks (SDLP, speed deviation, and task accuracy during the modified Surrogate Reference Task (mSuRT); coherence from the car following task). This outcome reflects the change in CDS from the pre-smoking assessment, at each timepoint. The z-score indicates the number of standard deviations away from the mean from the baseline performance for the entire group. A Z-score of 0 is equal to the mean of a reference population (in this case the pre-smoking performance for the entire group). Higher z-scores at each timepoint indicate worse performance (variables that went in the opposite direction were reflected in order to have all variables have the same direction). When examining the change in Composite Drive Score (this outcome variable), a higher score indicates a decline in performance (e.g., Time 2 minus Time1).
4 secondary outcomes
DRE Impairment
Time frame: Approximately 1.5 hours and 2.5 hours after alcohol/cannabis administration
Whole blood THC concentration
Time frame: Approximately 30 minutes after alcohol/cannabis administration
Oral Fluid THC concentration
Time frame: Approximately 30 minutes after alcohol/cannabis administration
Breath THC concentration
Time frame: Approximately 30 minutes after alcohol/cannabis administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 15094417Movig KL, Mathijssen MP, Nagel PH, van Egmond T, de Gier JJ, Leufkens HG, Egberts AC. Psychoactive substance use and the risk of motor vehicle accidents. Accid Anal Prev. 2004 Jul;36(4):631-6. doi: 10.1016/S0001-4575(03)00084-8.
- Results publication: PubMed 17063973Stuster J. Validation of the standardized field sobriety test battery at 0.08% blood alcohol concentration. Hum Factors. 2006 Fall;48(3):608-14. doi: 10.1518/001872006778606895.
- Results publication: PubMed 17916224Grotenhermen F, Leson G, Berghaus G, Drummer OH, Kruger HP, Longo M, Moskowitz H, Perrine B, Ramaekers JG, Smiley A, Tunbridge R. Developing limits for driving under cannabis. Addiction. 2007 Dec;102(12):1910-7. doi: 10.1111/j.1360-0443.2007.02009.x. Epub 2007 Oct 4.
- 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 21049267Ramaekers JG, Theunissen EL, de Brouwer M, Toennes SW, Moeller MR, Kauert G. Tolerance and cross-tolerance to neurocognitive effects of THC and alcohol in heavy cannabis users. Psychopharmacology (Berl). 2011 Mar;214(2):391-401. doi: 10.1007/s00213-010-2042-1. Epub 2010 Oct 30.
- 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 34173005Hoffman MA, Hubbard JA, Sobolesky PM, Smith BE, Suhandynata RT, Sanford S, Sones EG, Ellis S, Umlauf A, Huestis MA, Grelotti DJ, Grant I, Marcotte TD, Fitzgerald RL. Blood and Oral Fluid Cannabinoid Profiles of Frequent and Occasional Cannabis Smokers. J Anal Toxicol. 2021 Sep 17;45(8):851-862. doi: 10.1093/jat/bkab078.
- Results publication: PubMed 31527291Hubbard JA, Smith BE, Sobolesky PM, Kim S, Hoffman MA, Stone J, Huestis MA, Grelotti DJ, Grant I, Marcotte TD, Fitzgerald RL. Validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) method to detect cannabinoids in whole blood and breath. Clin Chem Lab Med. 2020 Apr 28;58(5):673-681. doi: 10.1515/cclm-2019-0600.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabis and Alcohol in people with Driving Impaired and Alcohol Intoxication, run by University of California, San Diego.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Composite Drive Score (time frame: Participants are assessed pre-smoking/drinking, and then approximately 30 minutes, 1 hour 30 minutes, and 3 hours 30 minutes post-smoking). 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 NCT05273658, which also lists 8 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 7 Sep 2023.