protocolSection identificationModule nctId: NCT06293040, orgStudyIdInfo id: IRB00434441, secondaryIdInfos id: R01DA052295, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA052295, briefTitle: Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: 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)., conditionsModule conditions: Cannabis Intoxication, conditions: Alcohol Intoxication, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants will complete all dose conditions (study arms) in a randomized order, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Cannabis, interventions name: Alcohol, interventions name: Placebo Cannabis, interventions name: Placebo Alcohol, outcomesModule primaryOutcomes measure: DRUID application global impairment score, primaryOutcomes measure: Correct Trials on Paced Auditory Serial Addition Task (PASAT), primaryOutcomes measure: Correct Trials on the Digit Symbol Substitution Task (DSST), primaryOutcomes measure: Cumulative score on Field Sobriety Tests, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Feel Drug Effect, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Feel High, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Confidence to Drive, primaryOutcomes measure: Drug Effect Questionnaire (DEQ) - Willingness to Drive, primaryOutcomes measure: Biphasic alcohol effects scale (BAES) - Sedative Score, primaryOutcomes measure: Biphasic alcohol effects scale (BAES) - Stimulant Score, primaryOutcomes measure: Subjective high assessment scale (SHAS), primaryOutcomes measure: Driving performance as assessed by standard deviation of lateral position (SDLP), primaryOutcomes measure: Driving performance as assessed by composite drive score, secondaryOutcomes measure: Driving performance as assessed by standard deviation of speed (SDSP), secondaryOutcomes measure: Driving performance (mean speed), secondaryOutcomes measure: Driving performance (number of speed exceedances), secondaryOutcomes measure: Driving performance (number of accidents), secondaryOutcomes measure: Driving performance (total rule violations), secondaryOutcomes measure: Driving performance (distance to lead vehicles), secondaryOutcomes measure: Attempted Trials on the Digit Symbol Substitution Task (DSST), secondaryOutcomes measure: Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST), secondaryOutcomes measure: Reaction time on Paced Auditory Serial Addition Task, secondaryOutcomes measure: Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test, secondaryOutcomes measure: Field Sobriety Test - Score on Walk and Turn test, secondaryOutcomes measure: Field Sobriety Test - Score on One Leg Stand, secondaryOutcomes measure: Field Sobriety Test - Score on Modified Romberg Balance, secondaryOutcomes measure: Drug Effect Questionnaire - Like Drug Effect, secondaryOutcomes measure: Drug Effect Questionnaire - Want more, secondaryOutcomes measure: Drug Effect Questionnaire - Dislike Drug Effect, secondaryOutcomes measure: Pharmacokinetics - CMax for THC and THC metabolites, secondaryOutcomes measure: Pharmacokinetics - AUC for THC and THC metabolites, secondaryOutcomes measure: Pharmacokinetics - Breath Alcohol Concentration (BAC), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Behavioral Pharmacology Research Unit, city: Baltimore, state: Maryland, zip: 21224, country: United States, contacts name: Madyson Slutzky, role: CONTACT, email: mslutzk1@jh.edu, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False