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Cannabinoid

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

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 45
Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral task performance as assessed by the DRUID app
Blood Pressure
Digit Symbol Substitution Task (DSST) score
+12 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

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
2,263 Previous Clinical Trials
14,823,095 Total Patients Enrolled
Ryan Vandrey, PhDPrincipal InvestigatorJohns Hopkins University
12 Previous Clinical Trials
515 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must be satisfied for prospective participants to qualify for this clinical trial?

"This clinical trial seeks 70 participants aged 18 to 45 who have a history of cannabis use. To qualify, individuals must give written consent and pass physical exams, urine and blood tests with negative results for recent cannabis or other drug abuse; additionally they must not be pregnant nor donated blood within the last 30 days. Furthermore, their BMI should range from 19-36 kg/m2 while having systolic blood pressure (SBP) of 150mmHg at most and diastolic BP 90 mmHg. Finally applicants need to report prior experience inhaling marijuana either via smoking or vaporization."

Answered by AI

Is the age eligibility for this clinical trial set at 18 years and above?

"In order to be accepted into this clinical trial, applicants must fall within the 18-45 age bracket. Conversely, there are 15 studies catered towards those under 18 and 47 directed at seniors over 65 years of age."

Answered by AI

Are new participants still able to join the current research project?

"Clinicaltrials.gov affirms that this clinical trial, listed since May 23rd 2022, is currently enrolling patients. The study was last updated on the following day of its original posting date."

Answered by AI

What is the current participation rate of this research endeavor?

"Affirmative. Per the clinicaltrials.gov database, this research endeavour is presently recruiting participants - it was initially put up on May 23rd 2022 and its most recent revision happened a day later. 70 individuals need to be enrolled at 1 medical facility."

Answered by AI

Has the FDA officially sanctioned Oral Delta-8-THC Cannabis?

"Our group has determined that Oral Delta-8-THC Cannabis is an acceptable risk, assigning it a score of 1. This decision was based on the fact that this trial is in its first stage and there is limited data confirming safety or effectivity."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
California
Other
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~25 spots leftby Jun 2025