Clinical trial NCT04931095: The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
Official title: The Impact of Oral 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: 2021-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: 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 study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.

Detailed description: This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, 10 or 25mg THC) and alcohol (either placebo or active; BAC of 0.05 percent); participants will always receive both an alcohol drink (active or placebo) and dose of cannabis (active or placebo). Participants will also complete a condition in which they administer alcohol (BAC: 0.08 percent) with placebo cannabis, as a positive control. Primary outcomes include performance on field sobriety tests, cognitive and psychomotor impairment, subjective drug effects, and simulated driving performance. Blood concentrations of THC and THC metabolites will also be determined.

Eligibility criteria: Inclusion Criteria:

1. Have provided written informed consent
2. Be between the ages of 21 and 55
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 a body mass index (BMI) in the range of 19 to 36 kg/m2
6. Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
7. Have not donated blood in the prior 30 days.
8. Report at least 2 days of binge drinking in the past 90 days (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
9. Report ≥ 1 use of cannabis in the past year
10. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
11. Report at least 1 instance of simultaneous alcohol and use in the past year.

Exclusion Criteria:

1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
2. Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety
3. History of or current evidence of significant medical condition
4. Evidence of current psychiatric condition \[(MINI for Diagnostic and Statistical Manual (DSM)-V)\]
5. Meet criteria for severe alcohol use disorder (MINI for DSM-V)
6. Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score \> 9
7. Been in treatment previously for alcohol or cannabis use disorder
8. Use of cannabis, on average, more than 2 times/week over past 3 months
9. Liver function tests more than 2x normal range
10. Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
11. Shipley vocabulary score \<18 (corresponds to 5th grade reading level).

Primary outcomes:
measure: DRUID application global impairment score
timeFrame: 7.5 hours
measure: Correct Trials on Paced Auditory Serial Addition Task (PASAT)
timeFrame: 7.5 hours
measure: Correct Trials on the Digit Symbol Substitution Task (DSST)
timeFrame: 7.5 hours
measure: Cumulative score on Field Sobriety Tests
timeFrame: 7.5 hours
measure: Drug Effect Questionnaire (DEQ) - Feel Drug Effect
timeFrame: 7.5 hours
measure: Drug Effect Questionnaire - Feel High
timeFrame: 7.5 hours
measure: Drug Effect Questionnaire - Confidence to Drive
timeFrame: 7.5 hours
measure: Drug Effect Questionnaire - Willingness to Drive
timeFrame: 7.5 hours
measure: Biphasic alcohol effects scale (BAES) - Sedative Score
timeFrame: 7.5 hours
measure: Biphasic alcohol effects scale (BAES) - Stimulant Score
timeFrame: 7.5 hours
measure: Subjective high assessment scale (SHAS)
timeFrame: 7.5 hours
measure: Driving performance as assessed by standard deviation of lateral position (SDLP)
timeFrame: 7.5 hours
measure: Driving performance as assessed by composite drive score
timeFrame: 7.5 hours
Secondary outcomes:
measure: Driving performance as assessed by standard deviation of speed (SDSP)
timeFrame: 7.5 hours
measure: Driving performance (mean speed)
timeFrame: 7.5 hours
measure: Driving performance (number of speed exceedances)
timeFrame: 7.5 hours
measure: Driving performance (number of accidents)
timeFrame: 7.5 hours
measure: Driving performance (total rule violations)
timeFrame: 7.5 hours
measure: Driving performance (distance to lead vehicles)
timeFrame: 7.5 hours
measure: Attempted Trials on the Digit Symbol Substitution Task (DSST)
timeFrame: 7.5 hours
measure: Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST)
timeFrame: 7.5 hours
measure: Reaction time on Paced Auditory Serial Addition Task
timeFrame: 7.5 hours
measure: Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
timeFrame: Up to 7.5 hours
measure: Field Sobriety Test - Score on Walk and Turn test
timeFrame: Up to 7.5 hours
measure: Field Sobriety Test - Score on One Leg Stand
timeFrame: Up to 7.5 hours
measure: Field Sobriety Test - Score on Modified Romberg Balance
timeFrame: Up to 7.5 hours
measure: Drug Effect Questionnaire - Like Drug Effect
timeFrame: 7.5 hours
measure: Drug Effect Questionnaire - Want more
timeFrame: 7.5 hours
measure: Drug Effect Questionnaire - Dislike Drug Effect
timeFrame: 7.5 hours
measure: Pharmacokinetics - CMax for THC and THC metabolites
timeFrame: 7.5 hours
measure: Pharmacokinetics - AUC for THC and THC metabolites
timeFrame: Up to 7.5 hours
measure: Pharmacokinetics - Breath Alcohol Concentration (BAC)
timeFrame: Up to 7.5 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: