The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
2 other identifiers
interventional
60
1 country
1
Brief Summary
This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
February 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2025
CompletedOctober 3, 2025
October 1, 2025
3.5 years
June 11, 2021
October 2, 2025
Conditions
Outcome Measures
Primary Outcomes (13)
DRUID application global impairment score
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
7.5 hours
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).
7.5 hours
Correct Trials on the Digit Symbol Substitution Task (DSST)
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).
7.5 hours
Cumulative score on Field Sobriety Tests
Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance. We will report the cumulative amount of clues observed across these tasks (out of a possible 22 clues).
7.5 hours
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
7.5 hours
Drug Effect Questionnaire - Feel High
The DEQ will be used to obtain subjective ratings of "feel high". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
7.5 hours
Drug Effect Questionnaire - Confidence to Drive
The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
7.5 hours
Drug Effect Questionnaire - Willingness to Drive
The DEQ will be used to obtain subjective ratings of "willingness to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
7.5 hours
Biphasic alcohol effects scale (BAES) - Sedative Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70).
7.5 hours
Biphasic alcohol effects scale (BAES) - Stimulant Score
The BAES is used to assess sedative and stimulant subjective effects of alcohol. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70).
7.5 hours
Subjective high assessment scale (SHAS)
For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol. These items are integrated to produce an overall SHAS score (0-130)
7.5 hours
Driving performance as assessed by standard deviation of lateral position (SDLP)
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
7.5 hours
Driving performance as assessed by composite drive score
Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores
7.5 hours
Secondary Outcomes (19)
Driving performance as assessed by standard deviation of speed (SDSP)
7.5 hours
Driving performance (mean speed)
7.5 hours
Driving performance (number of speed exceedances)
7.5 hours
Driving performance (number of accidents)
7.5 hours
Driving performance (total rule violations)
7.5 hours
- +14 more secondary outcomes
Study Arms (7)
Placebo cannabis + placebo alcohol
PLACEBO COMPARATORParticipants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.
low dose cannabis with placebo alcohol
EXPERIMENTALParticipants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.
high dose cannabis with placebo alcohol
EXPERIMENTALParticipants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.
low dose cannabis with low dose alcohol
EXPERIMENTALParticipants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).
high dose cannabis with low dose alcohol
EXPERIMENTALParticipants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
Placebo cannabis + low dose alcohol
EXPERIMENTALParticipants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
Placebo cannabis + high dose alcohol
EXPERIMENTALParticipants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
Interventions
Cannabis will be orally ingested via a brownie
Alcohol will be orally ingested via a flavored drink
Eligibility Criteria
You may qualify if:
- Have provided written informed consent
- Be between the ages of 21 and 55
- 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.
- Have a body mass index (BMI) in the range of 19 to 36 kg/m2
- 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
- Have not donated blood in the prior 30 days.
- 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)
- Report ≥ 1 use of cannabis in the past year
- Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
- Report at least 1 instance of simultaneous alcohol and use in the past year.
You may not qualify if:
- Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
- 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
- History of or current evidence of significant medical condition
- Evidence of current psychiatric condition \[(MINI for Diagnostic and Statistical Manual (DSM)-V)\]
- Meet criteria for severe alcohol use disorder (MINI for DSM-V)
- Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score \> 9
- Been in treatment previously for alcohol or cannabis use disorder
- Use of cannabis, on average, more than 2 times/week over past 3 months
- Liver function tests more than 2x normal range
- Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
- Shipley vocabulary score \<18 (corresponds to 5th grade reading level).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tory Spindle, PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 18, 2021
Study Start
February 17, 2022
Primary Completion
August 15, 2025
Study Completion
August 15, 2025
Last Updated
October 3, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share