Medium THC for Cannabis Impairment

Olin Neuropsychiatry Research Center, Hartford, CT
Cannabis ImpairmentMedium THC - Drug
Eligibility
18 - 55
All Sexes

Study Summary

This trial will aim to increase understanding of how smoked cannabis affects cognition and driving ability, as well as how long these effects last. It will also look at how prior experience with cannabis use affects these abilities.

Eligible Conditions
  • Cannabis Impairment

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Post placebo at 10 minutes and post active dose administration at 210 minutes.
Change in performance on simulated driving Road Tracking Task.
Post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Marijuana induced performance changes on Cogstate Groton Maze Learning task.
Marijuana induced performance changes on Inquisit Maze Learning task.
Marijuana induced performance changes on the Time Reproduction Task.
Post placebo at 5 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.
Change in concentration of THC/metabolites in blood samples.

Trial Safety

Side Effects for

Dronabinol Cap 5 Milligrams (MG)
13%Nausea and Dizziness
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03008005) in the Dronabinol Cap 5 Milligrams (MG) ARM group. Side effects include: Nausea and Dizziness with 13%.

Trial Design

2 Treatment Groups

Placebo Marijuana
1 of 2
Medium THC Marijuana
1 of 2

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Medium THC · Has Placebo Group · Phase 1

Placebo Marijuana
Drug
Experimental Group · 1 Intervention: Placebo THC · Intervention Types: Drug
Medium THC Marijuana
Drug
Experimental Group · 1 Intervention: Medium THC · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: post placebo at 30 minutes and post active dose administration at: 30 minutes, 60 minutes , 90 minutes, 120 minutes, 150 minutes, 180 minutes.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,729 Previous Clinical Trials
20,526,954 Total Patients Enrolled
National Highway Traffic Safety Administration (NHTSA)FED
6 Previous Clinical Trials
883 Total Patients Enrolled
Hartford HospitalOTHER
121 Previous Clinical Trials
17,091 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,305 Previous Clinical Trials
2,022,961 Total Patients Enrolled
Godfrey Pearlson, M.DPrincipal InvestigatorYale University
2 Previous Clinical Trials
32 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been using drugs through needle injections frequently and have experienced feeling high from them recently.

Who else is applying?

What state do they live in?
Connecticut33.3%
Texas33.3%
New Jersey33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Olin Neuropsychiatry Research Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. Olin Neuropsychiatry Research Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call50.0%
Email50.0%

Frequently Asked Questions

Are youthful participants being accepted for the experiment?

"Participants must fall in the 18 to 55 year old demographic to be considered for this study. For those who are younger or older than that age bracket, there are various other trials available with different eligibility requirements." - Anonymous Online Contributor

Unverified Answer

To what degree could consuming Medium THC be detrimental to a patient's health?

"The minimal evidence regarding Medium THC's safety and efficacy leads to a score of 1." - Anonymous Online Contributor

Unverified Answer

What is the magnitude of people involved in this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this medical experiment, which was originally posted on August 25th 2022, is currently recruiting participants. 32 individuals must be recruited from a single site for the trial's completion." - Anonymous Online Contributor

Unverified Answer

Is this experiment pioneering a new approach?

"Presently, 32 cities across 5 countries are hosting 31 distinct clinical trials for a pharmaceutical called 'Medium THC'. Jazz Pharmaceuticals initiated the first study of its kind in 2015 and it was composed of 200 patients. Since then, 60 such experiments have been concluded." - Anonymous Online Contributor

Unverified Answer

Are there any reports of previous research on the effects of Medium THC?

"Currently, 31 clinical trials involving Medium THC are actively running with 3 of them in their finale stage. Hartford Connecticut is the hub for many of these studies; however, there are 46 other locations that administer tests and collect data on this medication." - Anonymous Online Contributor

Unverified Answer

Is enrollment still available for this experiment?

"Indeed, the information hosted on clinicaltrials.gov denotes that this investigation is presently recruiting participants. This venture was initially posted on August 25th 2022 and has since been amended; 32 people are sought from a single location." - Anonymous Online Contributor

Unverified Answer

To what extent should certain individuals be targeted to enroll in this experiment?

"For acceptance into this trial, applicants should have a history of marijuana abuse and be between the ages of 18-55. This research project has 32 available slots in total." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.