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Delta-8-THC vs. Delta-9-THC for Cannabis Effects
Phase 1
Recruiting
Led By Ryan Vandrey, 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 18 and 55
Be between 18 and 65 years old
Must not have
Current concomitant medication use that may interact with the study drug (∆8-THC and ∆9-THC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-8 hours
Summary
This trial will study the effects of delta-8-THC, a compound found in hemp, on driving ability, cognitive performance, and biomarkers in the body. Delta-8-THC
Who is the study for?
This trial is for individuals who can safely participate in simulated driving tests and are interested in understanding the effects of different THC compounds. Specific eligibility criteria details were not provided, so participants should inquire with the study organizers for more information.
What is being tested?
The study is testing how Delta-8-THC compares to Delta-9-THC and a placebo on simulated driving performance. It will also look at their effects on field sobriety tests, cognitive abilities, and cannabinoid levels in the body after vaporization or oral ingestion.
What are the potential side effects?
While specific side effects are not listed, both forms of THC may cause altered perception, dizziness, dry mouth, red eyes, slowed reaction times and could impact short-term memory during use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medications that might interact with the study drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-8 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Standard Deviation of Lateral Position (SDLP) in cm
Secondary study objectives
Mean Peak Change From Baseline Drug Effect Rating as Assessed by the Drug Effect Questionnaire (DEQ)
Mean Peak Change From Baseline Global Impairment Score as assessed by the DRiving Under the Influence of Drugs (DRUID) App
Trial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral administration of 60mg ∆8-THCExperimental Treatment1 Intervention
A brownie infused with 60mg ∆8-THC will be eaten by study participants
Group II: Oral administration of 30mg ∆9-THCExperimental Treatment1 Intervention
A brownie infused with 30mg ∆9-THC will be eaten by study participants
Group III: Oral administration of 30mg ∆8-THCExperimental Treatment1 Intervention
A brownie infused with 30mg ∆8-THC will be eaten by study participants
Group IV: Administration of vaporized 60mg ∆8-THCExperimental Treatment1 Intervention
Participants will inhale 60mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")
Group V: Administration of vaporized 30mg ∆9-THCExperimental Treatment1 Intervention
Participants will inhale 30mg ∆9-THC using a handheld vaporizer (minimum 15 "puffs")
Group VI: Administration of vaporized 30mg ∆8-THCExperimental Treatment1 Intervention
Participants will inhale 30mg ∆8-THC using a handheld vaporizer (minimum 15 "puffs")
Group VII: Oral PlaceboPlacebo Group1 Intervention
A brownie containing no experimental drugs will be eaten by study participants
Group VIII: Administration of vaporized PlaceboPlacebo Group1 Intervention
Participants will inhale ambient air through a handheld vaporizer (minimum 15 "puffs")
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Delta-9-THC
2021
Completed Early Phase 1
~70
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Substance Abuse and Mental Health Services Administration (SAMHSA)FED
30 Previous Clinical Trials
23,221 Total Patients Enrolled
2 Trials studying Cannabis
71 Patients Enrolled for Cannabis
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,569 Total Patients Enrolled
7 Trials studying Cannabis
196 Patients Enrolled for Cannabis
Ryan Vandrey, PhDPrincipal InvestigatorJohns Hopkins University
12 Previous Clinical Trials
454 Total Patients Enrolled
2 Trials studying Cannabis
42 Patients Enrolled for Cannabis
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