INTERVENTIONALCOMPLETEDNCT04931095

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

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-03

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1
Enrollment: 70 (ACTUAL)
Start date: 2022-02-17
Sponsor: Johns Hopkins University
Design: RANDOMIZED · CROSSOVER · BASIC SCIENCE
Locations: 1
Results record: Present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Cannabis

Cannabis will be orally ingested via a brownie

DRUG

Alcohol

Alcohol will be orally ingested via a flavored drink

Source-reported results

Results posted to the registry

27 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 11
Secondary outcomes: 16
Statistical analyses: 0
Adverse-event terms: 1

PRIMARYMean Peak Change From Baseline DRUID Application Global Impairment Score

Time frame: 7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
Measure: MEAN · score on scale
Reporting status: POSTED

Acute cognitive and behavioral impairment will be assessed with global impairment score (range 0-100) on the DRUID app (higher scores indicate greater impairment). Results are mean change from baseline.

Population: Includes completers (25).

Group	N	Value	Spread / interval
Placebo Cannabis + Placebo Alcohol	25	-2.1	6.8
Low Dose Cannabis With Placebo Alcohol	25	4.6	7.8
High Dose Cannabis With Placebo Alcohol	25	5.5	7.8
Low Dose Cannabis With Low Dose Alcohol	25	3.3	7.5
High Dose Cannabis With Low Dose Alcohol	25	2.6	20.5
Placebo Cannabis + Low Dose Alcohol	25	2.9	8.1
Placebo Cannabis + High Dose Alcohol	25	5.1	10.1

PRIMARYCumulative Score on Field Sobriety Tests

Time frame: 7.5 hours
Measure: MEAN · score on a scale

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepted

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

primary measures

Mean Peak Change From Baseline DRUID Application Global Impairment Score

Time frame: 7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.

Cumulative Score on Field Sobriety Tests

Time frame: 7.5 hours

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 0-22 clues). Higher scores indicate greater/worse impairment. These assessments were completed once after 7.5 hours.

Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect

Time frame: 7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion

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. Results are mean change from baseline and a higher score indicates a more extreme/worse drug effect.

Drug Effect Questionnaire - Feel High

Time frame: 7.5 hours

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. Higher score greater "feel high" rating.

Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)

Time frame: 7.5 hours

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. Higher scores indicate higher confidence to drive. Results expressed as change from baseline

Drug Effect Questionnaire - Willingness to Drive

Time frame: 7.5 hours

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. Higher score indicates higher willingness to drive.

secondary outcomes