Cannabis IntoxicationPhase 1NCT04931095
The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
A Phase 1 study testing Cannabis and Alcohol in people with Cannabis Intoxication and Alcohol Intoxication, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Intoxication, Alcohol Intoxication
- What is being tested?
- Cannabis and Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 15 Aug 2025
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have provided written informed consent
- Be between the ages of 21 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
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- Have not donated blood in the prior 30 days.
- Report at least 2 days of binge drinking in the past 90 days (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
- Report ≥ 1 use of cannabis in the past year
- Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
- Report at least 1 instance of simultaneous alcohol and use in the past year.
Who cannot join
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety
- History of or current evidence of significant medical condition
- Evidence of current psychiatric condition [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score > 9
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- Been in treatment previously for alcohol or cannabis use disorder
- Use of cannabis, on average, more than 2 times/week over past 3 months
- Liver function tests more than 2x normal range
- Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
- Shipley vocabulary score <18 (corresponds to 5th grade reading level).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.
Read the detailed description
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, 10 or 25mg THC) and alcohol (either placebo or active; BAC of 0.05 percent); participants will always receive both an alcohol drink (active or placebo) and dose of cannabis (active or placebo). Participants will also complete a condition in which they administer alcohol (BAC: 0.08 percent) with placebo cannabis, as a positive control. Primary outcomes include performance on field sobriety tests, cognitive and psychomotor impairment, subjective drug effects, and simulated driving performance. Blood concentrations of THC and THC metabolites will also be determined.
- Conditions
- Cannabis Intoxication, Alcohol Intoxication
- Being tested
- Cannabis, Alcohol
- Medical subject headings
- Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Cannabis will be orally ingested via a brownie
AlcoholDrug
Alcohol will be orally ingested via a flavored drink
| Study group | Role | What they receive |
|---|---|---|
| Placebo cannabis + placebo alcohol | Placebo comparator | Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink. Receives: Drug: Cannabis; Drug: Alcohol |
| low dose cannabis with placebo alcohol | Experimental | Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink. Receives: Drug: Cannabis; Drug: Alcohol |
| high dose cannabis with placebo alcohol | Experimental | Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink. Receives: Drug: Cannabis; Drug: Alcohol |
| low dose cannabis with low dose alcohol | Experimental | Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC). Receives: Drug: Cannabis; Drug: Alcohol |
| high dose cannabis with low dose alcohol | Experimental | Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC). Receives: Drug: Cannabis; Drug: Alcohol |
| Placebo cannabis + low dose alcohol | Experimental | Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC). Receives: Drug: Cannabis; Drug: Alcohol |
| Placebo cannabis + high dose alcohol | Experimental | Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC). Receives: Drug: Cannabis; Drug: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Peak Change From Baseline DRUID Application Global Impairment Score
Acute cognitive and behavioral impairment will be assessed with global impairment score (range 0-100) on the DRUID app (higher scores indicate greater impairment). Results are mean change from baseline.
Measured: 7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
Cumulative Score on Field Sobriety Tests
Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance. We will report the cumulative amount of clues observed across these tasks (out of a possible 0-22 clues). Higher scores indicate greater/worse impairment. These assessments were completed once after 7.5 hours.
Measured: 7.5 hours
Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Results are mean change from baseline and a higher score indicates a more extreme/worse drug effect.
Measured: 7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion
Drug Effect Questionnaire - Feel High
The DEQ will be used to obtain subjective ratings of "feel high". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher score greater "feel high" rating.
Measured: 7.5 hours
Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher scores indicate higher confidence to drive. Results expressed as change from baseline
Measured: 7.5 hours
Drug Effect Questionnaire - Willingness to Drive
The DEQ will be used to obtain subjective ratings of "willingness to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher score indicates higher willingness to drive.
Measured: 7.5 hours
Biphasic Alcohol Effects Scale (BAES) - Sedative Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70). Higher scores indicating greater sedative effects of alcohol. Scores presented show the change from baseline to 7.5 hours.
Measured: Baseline, 7.5 hours
Biphasic Alcohol Effects Scale (BAES) - Stimulant Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70). Higher scores indicating greater stimulant effects of alcohol.
Measured: 7.5 hours
Subjective High Assessment Scale (SHAS)
For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol. These items are integrated to produce an overall SHAS score (0-130). Higher score indicates greater effects of alcohol.
Measured: 7.5 hours
Driving Performance as Assessed by Standard Deviation of Lateral Position (SDLP)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) was calculated across all drives to get a composite index of lateral control and reported as peak change from baseline. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance as Assessed by Composite Drive Score
Driving impairment will be assessed via a composite drive score. The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). Higher z-score indicates worse performance. The score is on a z-score scale, meaning a score of 1 equates to 1 standard deviation outside of the participants' mean baseline performance and a Z-score of 0 represents the mean baseline performance. This was calculated across all drives and reported as peak change from baseline.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Secondary outcomes (16)
Driving Performance as Assessed by Standard Deviation of Speed (SDSP)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDSP will be calculated across all drives to get a composite index of the variability in speed (measured in MPH) and is reported as peak change from baseline. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Total Run Length
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Total run length will be calculated across all drives and measured as peak change from baseline score (in seconds). Higher scores represent higher magnitude of driving impairment.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Number of Speed Exceedances)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Driving performance will be calculated across all drives to get a cumulative number of times participants exceed the allowable speed limit and reported as peak change from baseline. Scores range from 0 to no upper limit. Higher scores represent higher numbers of speed exceedances.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Number of Accidents)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Driving performance will be calculated across all drives to get a cumulative number of accidents (including car collisions, pedestrians hit, etc.) and reported as peak change from baseline. Scores range from 0 to no upper limit. Higher scores represent higher numbers of accidents.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Total Rule Violations)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Driving performance will be calculated across all drives to get a cumulative number of total rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) and reported as peak change from baseline. Scores range from 0 to no upper limit. Higher scores represent higher numbers of rule violations. All scores reported are relative to baseline, thus negative values represent a lower number of rule violations than at baseline.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Distance to Lead Vehicles)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Driving performance will be calculated across all drives to get the mean distance (in meters) maintained to lead vehicles during car-following segments and reported as peak change from baseline. Scores range from 0 to no upper limit. Higher scores represent greater distance maintained to lead vehicles. All scores reported are relative to baseline, thus negative values represent a shorter distance maintained than at baseline.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Change in Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Impairment will be assessed using performance on the Horizontal Gaze Nystagmus Test (HGN). Total score will be recorded (out of possible 0-6 clues) with higher scores indicating higher impairment. Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
Measured: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on Walk and Turn Test
Impairment will be assessed using performance on the the Walk and Turn. Total score will be recorded (out of a possible 0-8 clues) with higher scores indicating higher impairment. Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
Measured: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on One Leg Stand
Impairment will be assessed using performance on the One Leg Stand test. Total score will be recorded (out of a possible 0-4 clues) with higher scores indicating higher impairment. Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
Measured: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on Modified Romberg Balance
Impairment will be assessed using performance on the Modified Romberg Balance test. Total score will be recorded (out of a possible 0-4 clues) with higher scores indicating higher impairment. Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
Measured: Baseline, 7.5 hours
Drug Effect Questionnaire - Like Drug Effect
The DEQ will be used to obtain subjective ratings of "like drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher score indicating greater "liked drug effect" rating.
Measured: 7.5 hours
Drug Effect Questionnaire - Dislike Drug Effect
The DEQ will be used to obtain subjective ratings of "dislike drug effect". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher score indicating greater "dislike drug effect" rating.
Measured: 7.5 hours
Pharmacokinetics - CMax for THC and THC Metabolites
Whole blood concentrations of THC, 11-OH-THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The maximum concentration (Cmax) is determined as the highest concentration reached for each individual (ng/mL) across all timepoints.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - AUC for THC and THC Metabolites
Whole blood concentrations of THC, 11-OH-THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated cumulative across all timepoints.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - CMax for Alcohol
BAC will be measured using the Alco-Sensor IV. Measuring BAC is needed to confirm that participants reached the targeted BAC for a given session and to confirm adherence to pre-session alcohol abstinence requirements (g/210L). The maximum concentration (Cmax) is determined as the highest concentration reached for each individual (ng/mL) across all timepoints.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - AUC for Alcohol
Whole blood concentrations of Alcohol will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis. The area under the curve (AUC) is calculated cumulative across all timepoints.
Measured: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start17 Feb 2022
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis IntoxicationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Tory Spindle, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931095
- Sponsor's protocol ID
- IRB00290015
- Other IDs
- 1R01DA052295-01
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2021
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zamarripa CA, Lin S, Klausner M, Rastogi K, Roche DJO, Novak M, Antoine D, Wolinsky D, Marcotte TD, Weerts EM, Vandrey R, Spindle TR. Impact of Cannabis Edibles Combined With Alcohol on Driving, Field Sobriety Performance, and Subjective Effects: A Within-Participant Crossover Trial. JAMA Netw Open. 2026 May 1;9(5):e269842. doi: 10.1001/jamanetworkopen.2026.9842.
PubMed 42065887
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
- ClinicalTrials.gov ID
- NCT04931095
- Acronym / sponsor ID
- IRB00290015
- Conditions
- Cannabis Intoxication, Alcohol Intoxication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.
Detailed description
This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, 10 or 25mg THC) and alcohol (either placebo or active; BAC of 0.05 percent); participants will always receive both an alcohol drink (active or placebo) and dose of cannabis (active or placebo). Participants will also complete a condition in which they administer alcohol (BAC: 0.08 percent) with placebo cannabis, as a positive control. Primary outcomes include performance on field sobriety tests, cognitive and psychomotor impairment, subjective drug effects, and simulated driving performance. Blood concentrations of THC and THC metabolites will also be determined.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
- Model description
- All participants will complete all dose conditions (study arms) in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Placebo cannabis + placebo alcohol | Placebo comparator | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink. |
| low dose cannabis with placebo alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink. |
| high dose cannabis with placebo alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink. |
| low dose cannabis with low dose alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC). |
| high dose cannabis with low dose alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC). |
| Placebo cannabis + low dose alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC). |
| Placebo cannabis + high dose alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Have provided written informed consent
- Be between the ages of 21 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit.
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
Key exclusion criteria (11 listed)
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety
- History of or current evidence of significant medical condition
- Evidence of current psychiatric condition [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
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 |
|---|---|---|
| CannabisCannabis will be orally ingested via a brownie | Drug | Placebo cannabis + high dose alcohol, Placebo cannabis + low dose alcohol, Placebo cannabis + placebo alcohol, high dose cannabis with low dose alcohol, high dose cannabis with placebo alcohol, low dose cannabis with low dose alcohol, low dose cannabis with placebo alcohol |
| AlcoholAlcohol will be orally ingested via a flavored drink | Drug | Placebo cannabis + high dose alcohol, Placebo cannabis + low dose alcohol, Placebo cannabis + placebo alcohol, high dose cannabis with low dose alcohol, high dose cannabis with placebo alcohol, low dose cannabis with low dose alcohol, low dose cannabis with placebo alcohol |
Primary outcome
Mean Peak Change From Baseline DRUID Application Global Impairment Score
Time frame: 7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
Acute cognitive and behavioral impairment will be assessed with global impairment score (range 0-100) on the DRUID app (higher scores indicate greater impairment). Results are mean change from baseline.
Cumulative Score on Field Sobriety Tests
Time frame: 7.5 hours
Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance. We will report the cumulative amount of clues observed across these tasks (out of a possible 0-22 clues). Higher scores indicate greater/worse impairment. These assessments were completed once after 7.5 hours.
Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect
Time frame: 7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Results are mean change from baseline and a higher score indicates a more extreme/worse drug effect.
Drug Effect Questionnaire - Feel High
Time frame: 7.5 hours
The DEQ will be used to obtain subjective ratings of "feel high". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher score greater "feel high" rating.
Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)
Time frame: 7.5 hours
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher scores indicate higher confidence to drive. Results expressed as change from baseline
Drug Effect Questionnaire - Willingness to Drive
Time frame: 7.5 hours
The DEQ will be used to obtain subjective ratings of "willingness to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation. Higher score indicates higher willingness to drive.
Biphasic Alcohol Effects Scale (BAES) - Sedative Score
Time frame: Baseline, 7.5 hours
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70). Higher scores indicating greater sedative effects of alcohol. Scores presented show the change from baseline to 7.5 hours.
Biphasic Alcohol Effects Scale (BAES) - Stimulant Score
Time frame: 7.5 hours
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70). Higher scores indicating greater stimulant effects of alcohol.
Subjective High Assessment Scale (SHAS)
Time frame: 7.5 hours
For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol. These items are integrated to produce an overall SHAS score (0-130). Higher score indicates greater effects of alcohol.
Driving Performance as Assessed by Standard Deviation of Lateral Position (SDLP)
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) was calculated across all drives to get a composite index of lateral control and reported as peak change from baseline. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Driving Performance as Assessed by Composite Drive Score
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving impairment will be assessed via a composite drive score. The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). Higher z-score indicates worse performance. The score is on a z-score scale, meaning a score of 1 equates to 1 standard deviation outside of the participants' mean baseline performance and a Z-score of 0 represents the mean baseline performance. This was calculated across all drives and reported as peak change from baseline.
16 secondary outcomes
Driving Performance as Assessed by Standard Deviation of Speed (SDSP)
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Total Run Length
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Number of Speed Exceedances)
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Number of Accidents)
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Total Rule Violations)
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Driving Performance (Distance to Lead Vehicles)
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Change in Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Time frame: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on Walk and Turn Test
Time frame: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on One Leg Stand
Time frame: Baseline, 7.5 hours
Change in Field Sobriety Test - Score on Modified Romberg Balance
Time frame: Baseline, 7.5 hours
Drug Effect Questionnaire - Like Drug Effect
Time frame: 7.5 hours
Drug Effect Questionnaire - Dislike Drug Effect
Time frame: 7.5 hours
Pharmacokinetics - CMax for THC and THC Metabolites
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - AUC for THC and THC Metabolites
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - CMax for Alcohol
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Pharmacokinetics - AUC for Alcohol
Time frame: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42065887Zamarripa CA, Lin S, Klausner M, Rastogi K, Roche DJO, Novak M, Antoine D, Wolinsky D, Marcotte TD, Weerts EM, Vandrey R, Spindle TR. Impact of Cannabis Edibles Combined With Alcohol on Driving, Field Sobriety Performance, and Subjective Effects: A Within-Participant Crossover Trial. JAMA Netw Open. 2026 May 1;9(5):e269842. doi: 10.1001/jamanetworkopen.2026.9842.
- Individual participant dataSharing planned: No
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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.
Tory Spindle, PhD principal investigator
Johns Hopkins University
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 and Alcohol in people with Cannabis Intoxication and Alcohol Intoxication, 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?
The sponsor lists 11 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 3 Aug 2026. 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. 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 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 2026). 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?
Mean Peak Change From Baseline DRUID Application Global Impairment Score (time frame: 7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.). The study lists 11 primary outcomes in all. 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 NCT04931095, which also lists 1 linked publication.
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 2026.