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 range21 Years – 55 Years

SexALL

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
✕. 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

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

Timeframe: 7.5 hours

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 range21 Years – 55 Years

SexALL

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
✕. 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

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

Timeframe: 7.5 hours