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