Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

September 10, 2025 updated by: Johns Hopkins University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Behavioral Pharmacology Research Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Have provided written informed consent
  2. Be at least 21 years of age
  3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
  4. 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
  5. Have not donated blood in the prior 30 days
  6. 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)
  7. Report at least 1 use of cannabis in the past 3 years
  8. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
  9. Report at least 1 lifetime instance of simultaneous alcohol and cannabis use
  10. 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

Exclusion Criteria:

  1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
  2. History of or current evidence of significant medical condition that would put the participant at risk
  3. Evidence of current psychiatric condition (MINI for DSM-V)
  4. Meet criteria for severe alcohol use disorder (MINI for DSM-V)
  5. CIWA-Ar score > 9
  6. Use of cannabis, on average, more than 3 days/week over past 3 months
  7. Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
  8. Shipley vocabulary score <18 (corresponds to 5th grade reading level)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo cannabis + placebo alcohol
Participants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink.
Drug: Placebo Cannabis
Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
Other Names:
  • Placebo
Drug: Placebo Alcohol
A non-alcoholic, placebo, flavored drink will be orally ingested.
Other Names:
  • Placebo
Experimental: Low dose cannabis with placebo alcohol
Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink.
Drug: Placebo Alcohol
A non-alcoholic, placebo, flavored drink will be orally ingested.
Other Names:
  • Placebo
Drug: Cannabis
Cannabis will be vaporized using the Mighty Medic
Other Names:
  • THC
Experimental: High dose cannabis with placebo alcohol
Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink.
Drug: Placebo Alcohol
A non-alcoholic, placebo, flavored drink will be orally ingested.
Other Names:
  • Placebo
Drug: Cannabis
Cannabis will be vaporized using the Mighty Medic
Other Names:
  • THC
Experimental: Low dose cannabis with low dose alcohol
Participants administer vaporized cannabis containing 5mg THC in combination with an alcohol drink (0.05 percent BAC).
Drug: Alcohol
Alcohol will be orally ingested via a flavored drink
Other Names:
  • Ethanol
Drug: Cannabis
Cannabis will be vaporized using the Mighty Medic
Other Names:
  • THC
Experimental: High dose cannabis with low dose alcohol
Participants administer vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
Drug: Alcohol
Alcohol will be orally ingested via a flavored drink
Other Names:
  • Ethanol
Drug: Cannabis
Cannabis will be vaporized using the Mighty Medic
Other Names:
  • THC
Experimental: Placebo cannabis + low dose alcohol
Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
Drug: Alcohol
Alcohol will be orally ingested via a flavored drink
Other Names:
  • Ethanol
Drug: Placebo Cannabis
Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
Other Names:
  • Placebo
Experimental: Placebo cannabis + high dose alcohol
Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
Drug: Alcohol
Alcohol will be orally ingested via a flavored drink
Other Names:
  • Ethanol
Drug: Placebo Cannabis
Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours
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).
Up to 6 hours
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).
Up to 6 hours
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)
Up to 6 hours
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.
Up to 6 hours
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.
Up to 6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Driving performance as assessed by standard deviation of speed (SDSP)
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. SDSP will be determined during each drive; this measure quantifies the variability in speed (in MPH) observed.
Up to 6 hours
Driving performance (mean speed)
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. Mean speed (in MPH) over the course of each drive will be determined.
Up to 6 hours
Driving performance (number of speed exceedances)
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. The cumulative number of times participants exceed the allowable speed limit during each drive.
Up to 6 hours
Driving performance (number of accidents)
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. The cumulative number of accidents (including car collisions, pedestrians hit, etc.) during each drive.
Up to 6 hours
Driving performance (total rule violations)
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. The cumulative number of rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) during each drive.
Up to 6 hours
Driving performance (distance to lead vehicles)
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. The mean distance (in meters) maintained to lead vehicles during car-following segments of each drive.
Up to 6 hours
Attempted 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. The number of attempted trials will be recorded
Up to 6 hours
Percentage Correct on attempted 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. Percentage of correct trials out of those attempted will be recorded
Up to 6 hours
Reaction time on Paced Auditory Serial Addition Task
Time Frame: Up to 6 hours
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.
Up to 6 hours
Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Time Frame: Up to 6 hours
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.
Up to 6 hours
Field Sobriety Test - Score on Walk and Turn test
Time Frame: Up to 6 hours
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.
Up to 6 hours
Field Sobriety Test - Score on One Leg Stand
Time Frame: Up to 6 hours
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.
Up to 6 hours
Field Sobriety Test - Score on Modified Romberg Balance
Time Frame: Up to 6 hours
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.
Up to 6 hours
Drug Effect Questionnaire - Like Drug Effect
Time Frame: Up to 6 hours
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.
Up to 6 hours
Drug Effect Questionnaire - Want more
Time Frame: Up to 6 hours
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.
Up to 6 hours
Drug Effect Questionnaire - Dislike Drug Effect
Time Frame: Up to 6 hours
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.
Up to 6 hours
Pharmacokinetics - CMax for THC and THC metabolites
Time Frame: Up to 6 hours
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.
Up to 6 hours
Pharmacokinetics - AUC for THC and THC metabolites
Time Frame: Up to 6 hours
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.
Up to 6 hours
Pharmacokinetics - Breath Alcohol Concentration (BAC)
Time Frame: Up to 6 hours
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.
Up to 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tory Spindle, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00434441
  • R01DA052295 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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