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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this outcome (vas scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Summary
This trial tests how different types of marijuana and alcohol affect driving in a simulated setting. It aims to understand the impact on driving skills, physical reactions, and behavior. The study focuses on people who might use these substances and drive.
Eligible Conditions
- Cannabis Use
- Alcohol Consumption
- Cannabis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ this outcome (vas scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome (vas scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Peak for Standard Deviation in Lane Position (SDLP)
Secondary study objectives
Observer-Rated Outcome: Mean Peak Score for Good Mood
Observer-Rated Outcome: Mean Peak Score for Relaxed
Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating
+2 moreSide effects data
From 2021 Phase 1 & 2 trial • 15 Patients • NCT0325392640%
Gastrointestinal upset
20%
Headache
13%
Trouble sleeping
13%
Eye dryness/discomfort
7%
Anxiety/Jittery
7%
Body pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lorcaserin + Marijuana
Placebo + Marijuana
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active Marijuana DoseExperimental Treatment1 Intervention
Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions
Group II: Active Alcohol DoseActive Control1 Intervention
Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions
Group III: Inactive Alcohol DosePlacebo Group2 Interventions
Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
Group IV: Inactive Marijuana DosePlacebo Group2 Interventions
Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Marijuana
2008
Completed Phase 2
~340
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Shanna Babalonis, PhDLead Sponsor
3 Previous Clinical Trials
101 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,577 Previous Clinical Trials
3,286,829 Total Patients Enrolled
33 Trials studying Cannabis Use
7,386 Patients Enrolled for Cannabis Use
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