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High Dose THC Marijuana for Cannabis Impairment

Phase < 1
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a current driver's license
Have used marijuana before
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
Awards & highlights

Study Summary

This trial will study how marijuana affects cognition and simulated driving over time.

Eligible Conditions
  • Cannabis Impairment

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post drug administration at: 5 min, 20 min, 1 hr 10 min, 1 hr 45 min, 2 hrs 30 min, 4 hrs, and 6 hrs 30 min. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Marijuana induced performance changes on Alertmeter.
Marijuana induced performance changes on Cogstate 1-back/2-back task.
Marijuana induced performance changes on Cogstate Card Learning.
+10 more
Secondary outcome measures
Change in concentration of THC/metabolites in blood samples.
Change in concentration of THC/metabolites in oral fluid tested using Draeger Drug Detection Kits.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
+3 more

Side effects data

From 2019 Phase 4 trial • 46 Patients • NCT03008005
13%
Nausea and Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Oral Capsule
Dronabinol Cap 5 Milligrams (MG)
Dronabinol Cap 10 Milligrams (MG)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Regular UsersExperimental Treatment3 Interventions
People who use marijuana regularly will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
Group II: Occasional UsersExperimental Treatment3 Interventions
People who use marijuana occasionally will be given a low dose THC marijuana, high dose THC marijuana and placebo marijuana, in a randomized order, at the five study visits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose THC Marijuana
2017
Completed Early Phase 1
~30
High Dose THC Marijuana
2017
Completed Early Phase 1
~30
Placebo Marijuana
2017
Completed Early Phase 1
~30

Find a Location

Who is running the clinical trial?

National Highway Traffic Safety AdministrationUNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
National Highway Traffic Safety Administration (NHTSA)FED
7 Previous Clinical Trials
915 Total Patients Enrolled
Hartford HospitalOTHER
132 Previous Clinical Trials
18,896 Total Patients Enrolled

Frequently Asked Questions

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

To what extent is this experimental research being conducted with human participants?

"Currently, this clinical trial is not accepting participants. It was originally posted in December 2017 and most recently updated on January 24th 2022. If you are seeking other medical studies related to marijuana use disorder or High Dose THC Marijuana, there are 117 and 31 trials respectively that require enrolment at the moment."

Answered by AI

For which individuals is enrollment in this trial permissible?

"To qualify for enrollment in this marijuana abuse trial, applicants must be between 20 and 40 years of age. Approximately 27 participants will ultimately join the study."

Answered by AI

Is this experimentation unprecedented in its field?

"Since its inaugural study in 2015, sponsored by Jazz Pharmaceuticals, research regarding High Dose THC Marijuana has been conducted extensively. This culminated in the drug receiving Phase 2 & 3 approval for clinical use after a 200-person trial. Currently, 31 live studies are being held across 32 cities and 5 nations internationally."

Answered by AI

What other experiments involving high doses of THC cannabis have been conducted?

"Currently, 31 clinical trials pertaining to High Dose THC Marijuana are ongoing with 3 of them in the late-stage Phase 3. While Hartford, Connecticut serves as a hub for research related to this compound, there is participation from 46 medical centres across the world."

Answered by AI

What are the ambitions of this medical trial?

"This clinical trial's primary evaluation metric is the alteration of performance on Cogstate Social/Emotional Cognition task when given Marijuana; this will be measured over a time frame of 10 minutes to 6.5 hours post-administration. Secondary objectives are the determination of changes in operational control (measured via standard deviation of lane position), concentration levels for THC and its metabolites in blood samples, as well as oral fluid tested using Quantisal Oral Fluid Collection devices."

Answered by AI

Is this research study still open to participants?

"As indicated by clinicaltrials.gov, this particular research project is no longer actively recruiting patients: it was initially posted in December 2017 and the last update occurred on January 24th 2022. Nonetheless, there are currently 148 other clinical trials seeking new participants."

Answered by AI

Does the eligibility criteria for this trial extend to those above 30 years of age?

"This research is seeking individuals between the ages of 20 and 40 to participate."

Answered by AI

Who else is applying?

What state do they live in?
Delaware
Connecticut
Massachusetts
Other
How old are they?
18 - 65
What site did they apply to?
Olin Neuropsychiatry Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
~4 spots leftby Mar 2025