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Cannabinoid

Delta-8 vs. Delta-9 THC for Cannabis Pharmacology

Phase 1
Waitlist Available
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 45
Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
Must not have
Epilepsy or a history of seizures
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 hours

Summary

This trial will study the effects of inhaling and ingesting Delta-8 THC, as compared to placebo and Delta-9 THC. Blood, urine, and hair samples will be collected from participants.

Who is the study for?
This trial is for healthy adults aged 18-45 who have used cannabis before. They must not be pregnant, nursing, or using other drugs and should have a BMI of 19-36 kg/m2. Participants need to test negative for recent cannabis use and other substances at screening and on session days.
What is being tested?
The study examines the effects of Delta-8 THC compared to Delta-9 THC and placebo when inhaled or ingested orally. It measures how these substances affect mood, body function, thinking skills, and collects bodily fluids like saliva, urine, blood, and hair samples.
What are the potential side effects?
Potential side effects may include changes in alertness, coordination issues, dry mouth, altered heart rate or blood pressure levels; however specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I test negative for drugs and alcohol during screenings.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have epilepsy or a history of seizures.
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I have a history of serious heart rhythm problems or vasospastic disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 8 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
Self-reported Drug Effect ratings on the Drug Effect Questionnaire (DEQ)
Secondary study objectives
Behavioral task performance as assessed by the DRUID app
Digit Symbol Substitution Task (DSST) score
Divided Attention as assessed by the DAT
+4 more

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral administration of 40mg D-8-THCExperimental Treatment1 Intervention
Single acute administration of cannabis containing 40mg Delta-8-THC baked into a brownie
Group II: Oral administration of 20mg D-9-THCExperimental Treatment1 Intervention
Single acute administration of cannabis containing 20mg Delta-9-THC baked into a brownie
Group III: Oral administration of 20mg D-8-THCExperimental Treatment1 Intervention
Single acute administration of cannabis containing 20mg Delta-8-THC baked into a brownie
Group IV: Oral administration of 10mg D-8-THCExperimental Treatment1 Intervention
Single acute administration of cannabis containing 10mg Delta-8-THC baked into a brownie
Group V: Administration of vaporized 40mg D-8-THCExperimental Treatment1 Intervention
Single acute administration of placebo cannabis containing 40mg Delta-8-THC via commercial vaporizer
Group VI: Administration of vaporized 20mg D-9-THCExperimental Treatment1 Intervention
Single acute administration of placebo cannabis containing 20mg Delta-9-THC via commercial vaporizer
Group VII: Administration of vaporized 20mg D-8-THCExperimental Treatment1 Intervention
Single acute administration of placebo cannabis containing 20mg Delta-8-THC via commercial vaporizer
Group VIII: Administration of vaporized 10mg D-8-THCExperimental Treatment1 Intervention
Single acute administration of placebo cannabis containing 10mg Delta-8-THC via commercial vaporizer
Group IX: Placebo Vaporized CannabisPlacebo Group1 Intervention
Single acute administration of placebo cannabis via commercial vaporizer
Group X: Placebo Oral CannabisPlacebo Group1 Intervention
Single acute administration of placebo cannabis baked into a brownie
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vaporized Delta-8-THC Cannabis
2022
Completed Phase 1
~30
Vaporized Delta-9-THC Cannabis
2022
Completed Phase 1
~30
Oral Delta-8-THC Cannabis
2022
Completed Phase 1
~30
Oral Delta-9-THC Cannabis
2022
Completed Phase 1
~30

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
23,238 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,913 Total Patients Enrolled
Ryan Vandrey, PhDPrincipal InvestigatorJohns Hopkins University
12 Previous Clinical Trials
471 Total Patients Enrolled
~8 spots leftby Nov 2025
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