Cannabis IntoxicationPhase 1NCT06293040
Vaporized 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 human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy 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
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have provided written informed consent
- Be at least 21 years of age
- 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 not donated blood in the prior 30 days
- Report at least 1 day of binge drinking in the past 3 months (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
Show all 10Show fewer
- Report at least 1 use of cannabis in the past 3 years
- 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 lifetime instance of simultaneous alcohol and cannabis use
- Current concomitant prescription medication use that may interact with the investigational study drug, including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B
Who cannot join
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
- History of or current evidence of significant medical condition that would put the participant at risk
- Evidence of current psychiatric condition (MINI for DSM-V)
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- CIWA-Ar score > 9
- Use of cannabis, on average, more than 3 days/week over past 3 months
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
Anna Kohler, akohler3@jh.edu
About this study
Official title: The Impact of Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).
Read the detailed description
This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 7 experimental drug administration sessions in randomized order where the participant will vaporize cannabis-containing capsules (or "pods") (containing 0, 5, or 25mg THC) with a drink that contains no alcohol or alcohol (alcohol-containing drinks will be calculated to produce a breath alcohol concentration, BAC, of 0.05%). There is also a positive control session where participants will vaporize placebo cannabis with an alcohol drink calculated to produce a BAC of 0.08%. Each session will last approximately 8 hours and will be separated by at least 48 hours to allow for sufficient drug washout. Participants may complete up to 2 sessions per week. Drugs will be administered in a double-blind and double-dummy fashion (i.e., participants will always receive both active or placebo cannabis and active or placebo alcohol). During each session, a battery of assessments including blood collection, subjective questionnaire administration, cognitive performance testing, and simulated driving will be conducted.
- Conditions
- Cannabis Intoxication, Alcohol Intoxication
- Being tested
- Cannabis, Alcohol, Placebo Cannabis, Placebo 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
Also called THC
Cannabis will be vaporized using the Mighty Medic
AlcoholDrug
Also called Ethanol
Alcohol will be orally ingested via a flavored drink
Placebo CannabisDrug
Also called Placebo
Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
Placebo AlcoholDrug
Also called Placebo
A non-alcoholic, placebo, flavored drink will be orally ingested.
| Study group | Role | What they receive |
|---|---|---|
| Placebo cannabis + placebo alcohol | Placebo comparator | Participants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink. Receives: Drug: Placebo Cannabis; Drug: Placebo Alcohol |
| Low dose cannabis with placebo alcohol | Experimental | Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink. Receives: Drug: Cannabis; Drug: Placebo Alcohol |
| High dose cannabis with placebo alcohol | Experimental | Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink. Receives: Drug: Cannabis; Drug: Placebo Alcohol |
| Low dose cannabis with low dose alcohol | Experimental | Participants administer vaporized cannabis containing 5mg 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 vaporized 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 vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC). Receives: Drug: Alcohol; Drug: Placebo Cannabis |
| Placebo cannabis + high dose alcohol | Experimental | Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC). Receives: Drug: Alcohol; Drug: Placebo Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 hours
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance). Score ranges from 0-90, with 0 representing no correct trials and 90 representing 100% correct trials.
Measured: Up to 6 hours
Correct Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance). There is no maximum score, with a score of 0 representing either no trials completed or no correct trials. The score reflects the number of correct trials.
Measured: Up to 6 hours
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. The cumulative amount of clues observed across these tasks (out of a possible 22 clues) will be reported.
Measured: Up to 6 hours
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.
Measured: Up to 6 hours
Drug Effect Questionnaire (DEQ) - 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.
Measured: Up to 6 hours
Drug Effect Questionnaire (DEQ) - Confidence to Drive
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.
Measured: Up to 6 hours
Drug Effect Questionnaire (DEQ) - 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.
Measured: Up to 6 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).
Measured: Up to 6 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).
Measured: Up to 6 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)
Measured: Up to 6 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) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. 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: Up to 6 hours
Driving performance as assessed by composite drive score
Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes. There is no upper or lower limit to possible scores.
Measured: Up to 6 hours
Secondary outcomes (19)
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 determined during each drive; this measure quantifies the variability in speed (in MPH) observed.
Measured: Up to 6 hours
Driving performance (mean speed)
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. Mean speed (in MPH) over the course of each drive will be determined.
Measured: Up to 6 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. The cumulative number of times participants exceed the allowable speed limit during each drive.
Measured: Up to 6 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. The cumulative number of accidents (including car collisions, pedestrians hit, etc.) during each drive.
Measured: Up to 6 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. The cumulative number of rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) during each drive.
Measured: Up to 6 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. The mean distance (in meters) maintained to lead vehicles during car-following segments of each drive.
Measured: Up to 6 hours
Attempted Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. The number of attempted trials will be recorded
Measured: Up to 6 hours
Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Percentage of correct trials out of those attempted will be recorded
Measured: Up to 6 hours
Reaction time on Paced Auditory Serial Addition Task
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. The mean reaction time (in milliseconds) to select correct responses will be recorded.
Measured: Up to 6 hours
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 6 clues, score ranges from 0-6) with higher scores indicating higher impairment.
Measured: Up to 6 hours
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 8 clues, score ranges from 0-8) with higher scores indicating higher impairment.
Measured: Up to 6 hours
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 4 clues, score ranges from 0-4) with higher scores indicating higher impairment.
Measured: Up to 6 hours
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 4 clues, score ranges from 0-4)) with higher scores indicating higher impairment.
Measured: Up to 6 hours
Drug Effect Questionnaire - Like Drug Effect
The DEQ will be used to obtain subjective ratings of "like drug effect". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: Up to 6 hours
Drug Effect Questionnaire - Want more
The DEQ will be used to obtain subjective ratings of "want more". Scores range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Measured: Up to 6 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.
Measured: Up to 6 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. Characterizing these cannabinoids will allow for adequate control for individual differences in drug absorption and metabolism in statistical analyses and assist with interpretation of subjective and behavioral outcomes.
Measured: Up to 6 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 across all timepoints, minus the baseline. Characterizing these cannabinoids will allow for adequate control for individual differences in drug absorption and metabolism in statistical analyses and assist with interpretation of subjective and behavioral outcomes.
Measured: Up to 6 hours
Pharmacokinetics - Breath Alcohol Concentration (BAC)
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.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start26 Sep 2024
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
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
- NCT06293040
- Sponsor's protocol ID
- IRB00434441
- Other IDs
- R01DA052295
- Status last verified
- Sep 2026
- First submitted
- 20 Feb 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
- ClinicalTrials.gov ID
- NCT06293040
- Acronym / sponsor ID
- IRB00434441
- Conditions
- Cannabis Intoxication, Alcohol Intoxication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2024 (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.
This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).
Detailed description
This study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete a screening visit, and, if eligible, will then complete 7 experimental drug administration sessions in randomized order where the participant will vaporize cannabis-containing capsules (or "pods") (containing 0, 5, or 25mg THC) with a drink that contains no alcohol or alcohol (alcohol-containing drinks will be calculated to produce a breath alcohol concentration, BAC, of 0.05%). There is also a positive control session where participants will vaporize placebo cannabis with an alcohol drink calculated to produce a BAC of 0.08%. Each session will last approximately 8 hours and will be separated by at least 48 hours to allow for sufficient drug washout. Participants may complete up to 2 sessions per week. Drugs will be administered in a double-blind and double-dummy fashion (i.e., participants will always receive both active or placebo cannabis and active or placebo alcohol). During each session, a battery of assessments including blood collection, subjective questionnaire administration, cognitive performance testing, and simulated driving will be conducted.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, 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: Placebo Cannabis, Drug: Placebo AlcoholParticipants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink. |
| Low dose cannabis with placebo alcohol | Experimental | Drug: Cannabis, Drug: Placebo AlcoholParticipants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink. |
| High dose cannabis with placebo alcohol | Experimental | Drug: Cannabis, Drug: Placebo AlcoholParticipants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink. |
| Low dose cannabis with low dose alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer vaporized cannabis containing 5mg THC in combination with an alcohol drink (0.05 percent BAC). |
| High dose cannabis with low dose alcohol | Experimental | Drug: Cannabis, Drug: AlcoholParticipants administer vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC). |
| Placebo cannabis + low dose alcohol | Experimental | Drug: Alcohol, Drug: Placebo CannabisParticipants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC). |
| Placebo cannabis + high dose alcohol | Experimental | Drug: Alcohol, Drug: Placebo CannabisParticipants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have provided written informed consent
- Be at least 21 years of age
- 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 not donated blood in the prior 30 days
Key exclusion criteria (8 listed)
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
- History of or current evidence of significant medical condition that would put the participant at risk
- Evidence of current psychiatric condition (MINI for DSM-V)
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- CIWA-Ar score > 9
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: THCCannabis will be vaporized using the Mighty Medic | Drug | 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 |
| AlcoholAlso: EthanolAlcohol will be orally ingested via a flavored drink | Drug | High dose cannabis with low dose alcohol, Low dose cannabis with low dose alcohol, Placebo cannabis + high dose alcohol, Placebo cannabis + low dose alcohol |
| Placebo CannabisAlso: PlaceboPlacebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic. | Drug | Placebo cannabis + high dose alcohol, Placebo cannabis + low dose alcohol, Placebo cannabis + placebo alcohol |
| Placebo AlcoholAlso: PlaceboA non-alcoholic, placebo, flavored drink will be orally ingested. | Drug | High dose cannabis with placebo alcohol, Low dose cannabis with placebo alcohol, Placebo cannabis + placebo alcohol |
Primary outcome
DRUID application global impairment score
Time frame: Up to 6 hours
Acute cognitive and behavioral impairment will be assessed with global impairment score (range 0-100) on the DRUID app (higher scores indicate greater impairment).
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Time frame: Up to 6 hours
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance). Score ranges from 0-90, with 0 representing no correct trials and 90 representing 100% correct trials.
Correct Trials on the Digit Symbol Substitution Task (DSST)
Time frame: Up to 6 hours
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance). There is no maximum score, with a score of 0 representing either no trials completed or no correct trials. The score reflects the number of correct trials.
Cumulative score on Field Sobriety Tests
Time frame: Up to 6 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. The cumulative amount of clues observed across these tasks (out of a possible 22 clues) will be reported.
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
Time frame: Up to 6 hours
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.
Drug Effect Questionnaire (DEQ) - Feel High
Time frame: Up to 6 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.
Drug Effect Questionnaire (DEQ) - Confidence to Drive
Time frame: Up to 6 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.
Drug Effect Questionnaire (DEQ) - Willingness to Drive
Time frame: Up to 6 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.
Biphasic alcohol effects scale (BAES) - Sedative Score
Time frame: Up to 6 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).
Biphasic alcohol effects scale (BAES) - Stimulant Score
Time frame: Up to 6 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).
Subjective high assessment scale (SHAS)
Time frame: Up to 6 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)
Driving performance as assessed by standard deviation of lateral position (SDLP)
Time frame: Up to 6 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) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. 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: Up to 6 hours
Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes. There is no upper or lower limit to possible scores.
19 secondary outcomes
Driving performance as assessed by standard deviation of speed (SDSP)
Time frame: Up to 6 hours
Driving performance (mean speed)
Time frame: Up to 6 hours
Driving performance (number of speed exceedances)
Time frame: Up to 6 hours
Driving performance (number of accidents)
Time frame: Up to 6 hours
Driving performance (total rule violations)
Time frame: Up to 6 hours
Driving performance (distance to lead vehicles)
Time frame: Up to 6 hours
Attempted Trials on the Digit Symbol Substitution Task (DSST)
Time frame: Up to 6 hours
Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)
Time frame: Up to 6 hours
Reaction time on Paced Auditory Serial Addition Task
Time frame: Up to 6 hours
Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Time frame: Up to 6 hours
Field Sobriety Test - Score on Walk and Turn test
Time frame: Up to 6 hours
Field Sobriety Test - Score on One Leg Stand
Time frame: Up to 6 hours
Field Sobriety Test - Score on Modified Romberg Balance
Time frame: Up to 6 hours
Drug Effect Questionnaire - Like Drug Effect
Time frame: Up to 6 hours
Drug Effect Questionnaire - Want more
Time frame: Up to 6 hours
Drug Effect Questionnaire - Dislike Drug Effect
Time frame: Up to 6 hours
Pharmacokinetics - CMax for THC and THC metabolites
Time frame: Up to 6 hours
Pharmacokinetics - AUC for THC and THC metabolites
Time frame: Up to 6 hours
Pharmacokinetics - Breath Alcohol Concentration (BAC)
Time frame: Up to 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Cannabis Use, Cannabis Intoxication
Not yet recruitingPhase 1
Effects of Cannabidiol (CBD) on a Fixed Dose of Delta-9-tetrahydrocannabinol (THC)
Cannabis Intoxication
RecruitingPhase 2
Pregnenolone as a Treatment for Cannabis Intoxication
Cannabis Intoxication
Recruiting
Contamination of Young Children Hair During Acute Cannabis Intoxication
Cannabis Intoxication in Children
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.
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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tory Spindle, PhD (410-550-0529, tspindle@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DRUID application global impairment score (time frame: Up to 6 hours). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.