CompletedPhase 1

The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment

United States60 participantsStarted 2022-02-17

Plain-language summary

This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DRUID application global impairment score

Timeframe: 7.5 hours

Correct Trials on Paced Auditory Serial Addition Task (PASAT)

Timeframe: 7.5 hours

Correct Trials on the Digit Symbol Substitution Task (DSST)

Timeframe: 7.5 hours

Cumulative score on Field Sobriety Tests

Timeframe: 7.5 hours

Drug Effect Questionnaire (DEQ) - Feel Drug Effect

Timeframe: 7.5 hours

Drug Effect Questionnaire - Feel High

Timeframe: 7.5 hours

Drug Effect Questionnaire - Confidence to Drive

Timeframe: 7.5 hours

Drug Effect Questionnaire - Willingness to Drive

Trial details

NCT IDNCT04931095

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-15

View on ClinicalTrials.gov More Cannabis Intoxication trials

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Exclusion criteria

. 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

What they're measuring

DRUID application global impairment score

Timeframe: 7.5 hours

Correct Trials on Paced Auditory Serial Addition Task (PASAT)

Timeframe: 7.5 hours

Correct Trials on the Digit Symbol Substitution Task (DSST)

Timeframe: 7.5 hours

Cumulative score on Field Sobriety Tests

Timeframe: 7.5 hours

Drug Effect Questionnaire (DEQ) - Feel Drug Effect

Timeframe: 7.5 hours

Drug Effect Questionnaire - Feel High

Timeframe: 7.5 hours

Drug Effect Questionnaire - Confidence to Drive

Timeframe: 7.5 hours

Drug Effect Questionnaire - Willingness to Drive