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Alcohol

Cannabis and Alcohol for 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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 hours

Summary

This trial will study how using alcohol and vaporized cannabis together affects cognitive and behavioral functions. 32 participants will take part in 7 sessions where they will either take a placebo or active cannabis through a

Who is the study for?
This trial is for individuals who can safely consume alcohol and cannabis. Participants will be tested on how these substances, alone or together, affect their thinking, behavior, and feelings. They must be able to attend multiple sessions and have no health conditions that would make the study unsafe for them.
What is being tested?
The study tests the effects of vaporized cannabis (with THC levels of either 0 mg as a placebo, 5 mg or 25 mg), combined with alcoholic or non-alcoholic drinks designed to reach specific blood alcohol concentrations. Each participant will try different combinations in a controlled setting over several visits.
What are the potential side effects?
Potential side effects may include typical reactions to cannabis such as altered senses, mood changes, impaired body movement and memory issues; and from alcohol like drowsiness, dizziness, increased risk-taking behavior, slurred speech and coordination problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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: Placebo cannabis + low dose alcoholExperimental Treatment2 Interventions
Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).
Group II: Placebo cannabis + high dose alcoholExperimental Treatment2 Interventions
Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).
Group III: Low dose cannabis with placebo alcoholExperimental Treatment2 Interventions
Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink.
Group IV: Low dose cannabis with low dose alcoholExperimental Treatment2 Interventions
Participants administer vaporized cannabis containing 5mg THC in combination with an alcohol drink (0.05 percent BAC).
Group V: High dose cannabis with placebo alcoholExperimental Treatment2 Interventions
Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink.
Group VI: High dose cannabis with low dose alcoholExperimental Treatment2 Interventions
Participants administer vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).
Group VII: Placebo cannabis + placebo alcoholPlacebo Group2 Interventions
Participants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabis
2014
Completed Phase 3
~780
Alcohol
2008
Completed Phase 3
~1360
Placebo Alcohol
2019
Completed Phase 1
~380

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
2,339 Previous Clinical Trials
14,881,541 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,725 Total Patients Enrolled
Tory Spindle, PhDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
294 Total Patients Enrolled
~60 spots leftby Aug 2027