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Alcohol

Cannabis + Alcohol on Impairment

Phase 1
Recruiting
Led By Tory Spindle, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between the ages of 21 and 50
Be between the ages of 21 and 55
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7.5 hours
Awards & highlights

Study Summary

This trial will study the effects of cannabis and alcohol on people's behavior and how impaired they feel.

Who is the study for?
Participants must be healthy adults aged 21-55, not pregnant or nursing, with a BMI of 19-36 kg/m2. They should have engaged in binge drinking at least twice in the past 90 days and used cannabis within the last year but no more than twice weekly over the past three months.Check my eligibility
What is being tested?
The study is examining how oral cannabis and alcohol affect people's subjective feelings of impairment and their actual performance on tasks. It will look at these substances both separately and together to understand their combined effects.See study design
What are the potential side effects?
Potential side effects may include typical reactions to cannabis such as altered perception, dizziness, dry mouth, red eyes; and for alcohol: impaired coordination, slurred speech, nausea. The combination might intensify these effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 50 years old.
Select...
I am between 21 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7.5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7.5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biphasic alcohol effects scale (BAES) - Sedative Score
Biphasic alcohol effects scale (BAES) - Stimulant Score
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
+10 more
Secondary outcome measures
Attempted Trials on the Digit Symbol Substitution Task (DSST)
Driving performance (distance to lead vehicles)
Driving performance (mean speed)
+16 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: low dose cannabis with placebo alcoholExperimental Treatment2 Interventions
Participants administer oral cannabis containing 10mg THC in combination with a placebo alcohol drink.
Group II: low dose cannabis with low dose alcoholExperimental Treatment2 Interventions
Participants administer oral cannabis containing 10mg THC in combination with an alcohol drink (0.05 percent BAC).
Group III: high dose cannabis with placebo alcoholExperimental Treatment2 Interventions
Participants administer oral cannabis containing 25mg THC in combination with a placebo alcohol drink.
Group IV: high dose cannabis with low dose alcoholExperimental Treatment2 Interventions
Participants administer oral cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
Group V: Placebo cannabis + low dose alcoholExperimental Treatment2 Interventions
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
Group VI: Placebo cannabis + high dose alcoholExperimental Treatment2 Interventions
Participants administer oral cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
Group VII: Placebo cannabis + placebo alcoholPlacebo Group2 Interventions
Participants administer oral cannabis containing 0mg THC in combination with a placebo alcohol drink.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alcohol
2008
Completed Phase 3
~2000
Cannabis
2014
Completed Phase 3
~810

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,407 Total Patients Enrolled
1 Trials studying Cannabis Intoxication
90 Patients Enrolled for Cannabis Intoxication
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,640 Total Patients Enrolled
1 Trials studying Cannabis Intoxication
90 Patients Enrolled for Cannabis Intoxication
Tory Spindle, PhDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
294 Total Patients Enrolled
1 Trials studying Cannabis Intoxication
90 Patients Enrolled for Cannabis Intoxication

Media Library

Alcohol (Alcohol) Clinical Trial Eligibility Overview. Trial Name: NCT04931095 — Phase 1
Cannabis Intoxication Research Study Groups: low dose cannabis with placebo alcohol, high dose cannabis with low dose alcohol, high dose cannabis with placebo alcohol, low dose cannabis with low dose alcohol, Placebo cannabis + low dose alcohol, Placebo cannabis + high dose alcohol, Placebo cannabis + placebo alcohol
Cannabis Intoxication Clinical Trial 2023: Alcohol Highlights & Side Effects. Trial Name: NCT04931095 — Phase 1
Alcohol (Alcohol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04931095 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this therapeutic research currently have any open enrollment slots?

"Data provided by clinicaltrials.gov indicates that this research is currently enrolling participants. The initial posting was made on February 17th 2022 and the last revision was completed on April 11th of the same year."

Answered by AI

Does this research program include elderly participants?

"This clinical trial targets applicants between the ages of 21 and 50. For patients outside that demographic, there are 25 studies for those below 18 years old and 77 for seniors aged over 65."

Answered by AI

Has the Food and Drug Administration authorized Cannabis for medical use?

"Since this is a Phase 1 clinical trial, the safety of cannabis has been assessed at a low score of one. This reflects that there is only limited data proving its efficacy and protective qualities."

Answered by AI

What results is this clinical trial intended to yield?

"The primary measure of success in this 7.5-hour trial will be Driving performance as assessed by standard deviation of lateral position (SDLP). Additional criteria include a Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test, Driving Performance (total rule violations), and Drug Effect Questionnaire - Want more scores between 0 and 100 with none/extreme designation."

Answered by AI

How many participants are being accepted into the study?

"Affirmative. Clinicaltrials.gov shows that this clinical trial, initially posted on February 17th 2022, is actively recruiting participants at the moment. The research team needs to bring in approximately 90 volunteers from 1 site."

Answered by AI

What is the process for signing up to participate in this clinical research?

"This trial is looking for 90 volunteers, between the ages of 21 and 50 that have a history of hashish abuse. In order to be admitted into this study participants must meet certain criteria: submit informed consent in writing, display general health during physical examination and screening tests (urine/blood), not pregnant or nursing if female with negative pregnancy test results at Screening Visit/study visits respectively, BMI within 19-36kg/m2 range, no blood donation in last 30 days,, report 5+ cannabis uses past year, present negative urine drug test (excluding THC) + breath alcohol test(0% BAC @Screening/+"

Answered by AI

Has Cannabis been previously investigated in other academic studies?

"At this time, 11 trials for Cannabis are in their last stage of research with 67 total studies being conducted. The majority of these investigations are based out of Lexington, Kentucky but an additional 1,010 sites have been identified to be researching the drug."

Answered by AI

What health ailments has Cannabis been known to combat?

"Cannabis is generally employed to treat hypertrophic cardiomyopathy, but its medicinal benefits can also be utilised for communicable diseases and ethylene glycol therapy as well as skin disinfection."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Met criteria
~28 spots leftby May 2025