Clinical trial NCT06293040: Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Official title: The Impact of Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cannabis Intoxication
Alcohol Intoxication
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete all dose conditions (study arms) in a randomized order
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: DRUID application global impairment score
timeFrame: Up to 6 hours
measure: Correct Trials on Paced Auditory Serial Addition Task (PASAT)
timeFrame: Up to 6 hours
measure: Correct Trials on the Digit Symbol Substitution Task (DSST)
timeFrame: Up to 6 hours
measure: Cumulative score on Field Sobriety Tests
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire (DEQ) - Feel Drug Effect
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire (DEQ) - Feel High
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire (DEQ) - Confidence to Drive
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire (DEQ) - Willingness to Drive
timeFrame: Up to 6 hours
measure: Biphasic alcohol effects scale (BAES) - Sedative Score
timeFrame: Up to 6 hours
measure: Biphasic alcohol effects scale (BAES) - Stimulant Score
timeFrame: Up to 6 hours
measure: Subjective high assessment scale (SHAS)
timeFrame: Up to 6 hours
measure: Driving performance as assessed by standard deviation of lateral position (SDLP)
timeFrame: Up to 6 hours
measure: Driving performance as assessed by composite drive score
timeFrame: Up to 6 hours
Secondary outcomes:
measure: Driving performance as assessed by standard deviation of speed (SDSP)
timeFrame: Up to 6 hours
measure: Driving performance (mean speed)
timeFrame: Up to 6 hours
measure: Driving performance (number of speed exceedances)
timeFrame: Up to 6 hours
measure: Driving performance (number of accidents)
timeFrame: Up to 6 hours
measure: Driving performance (total rule violations)
timeFrame: Up to 6 hours
measure: Driving performance (distance to lead vehicles)
timeFrame: Up to 6 hours
measure: Attempted Trials on the Digit Symbol Substitution Task (DSST)
timeFrame: Up to 6 hours
measure: Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)
timeFrame: Up to 6 hours
measure: Reaction time on Paced Auditory Serial Addition Task
timeFrame: Up to 6 hours
measure: Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
timeFrame: Up to 6 hours
measure: Field Sobriety Test - Score on Walk and Turn test
timeFrame: Up to 6 hours
measure: Field Sobriety Test - Score on One Leg Stand
timeFrame: Up to 6 hours
measure: Field Sobriety Test - Score on Modified Romberg Balance
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire - Like Drug Effect
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire - Want more
timeFrame: Up to 6 hours
measure: Drug Effect Questionnaire - Dislike Drug Effect
timeFrame: Up to 6 hours
measure: Pharmacokinetics - CMax for THC and THC metabolites
timeFrame: Up to 6 hours
measure: Pharmacokinetics - AUC for THC and THC metabolites
timeFrame: Up to 6 hours
measure: Pharmacokinetics - Breath Alcohol Concentration (BAC)
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tory Spindle, PhD
role: PRINCIPAL_INVESTIGATOR
References: