Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Cannabis
DrugCannabis will be vaporized using the Mighty Medic
Alcohol
DrugAlcohol will be orally ingested via a flavored drink
Placebo Cannabis
DrugPlacebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
Placebo Alcohol
DrugA non-alcoholic, placebo, flavored drink will be orally ingested.
Treatment groups
90 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Placebo cannabis + placebo alcoholPlacebo comparator 2 interventions
Group B: Low dose cannabis with placebo alcoholExperimental treatment 2 interventions
Group C: High dose cannabis with placebo alcoholExperimental treatment 2 interventions
Group D: Low dose cannabis with low dose alcoholExperimental treatment 2 interventions
Group E: High dose cannabis with low dose alcoholExperimental treatment 2 interventions
Group F: Placebo cannabis + low dose alcoholExperimental treatment 2 interventions
Group G: Placebo cannabis + high dose alcoholExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 6 hours2
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.
Time frame
Up to 6 hours3
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.
Time frame
Up to 6 hours4
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.
Time frame
Up to 6 hoursSecondary outcomes
1
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.
Time frame
Up to 6 hours2
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.
Time frame
Up to 6 hours3
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.
Time frame
Up to 6 hours4
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.
Time frame
Up to 6 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov