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
Qualifiers
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
Treatments tested in this trial
- Cannabis
- Alcohol
- Placebo Cannabis
- Placebo Alcohol
Treatment groups
90 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov