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Cannabinoid

Cannabis Edibles for Understanding Cannabis Use Effects

Phase 1
Waitlist Available
Led By Tory Spindle, 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 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights

Study Summary

This trial tests how THC-infused products affect healthy adults, with tasks, assessments, blood tests, and vitals monitored.

Who is the study for?
This trial is for healthy adults aged 21-55 who have used THC-dominant cannabis before. They must not be pregnant, nursing, or have a history of significant health issues. Participants should not use other drugs or alcohol and must pass drug screenings. A BMI between 16 to 38 kg/m2 is required.Check my eligibility
What is being tested?
The study tests how the body processes and responds to THC-infused chocolates, gummies, and drinks in fasted individuals through cognitive tasks, blood tests, and vital sign monitoring over nine sessions with overnight stays.See study design
What are the potential side effects?
Potential side effects may include altered cognitive function and psychomotor skills due to THC consumption. Other possible reactions are changes in mood or perception, dry mouth, increased heart rate, red eyes, coordination difficulties, memory impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
"Like Drug Effect" as assessed by the Drug Effect Questionnaire (DEQ)
"Want to take again" as assessed by the Drug Effect Questionnaire
Dronabinol
+7 more
Secondary outcome measures
"Feel Drug Effect" as assessed by the Drug Effect Questionnaire-
"Unpleasant Drug Effect" as assessed by the Drug Effect Questionnaire
AUC for CBD
+19 more

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose GummyExperimental Treatment1 Intervention
Participants will self-administer a gummy containing 10mg THC
Group II: Low Dose ChocolateExperimental Treatment1 Intervention
Participants will self-administer chocolate containing 10mg THC
Group III: Low Dose BeverageExperimental Treatment1 Intervention
Participants will self-administer a beverage containing 10mg THC
Group IV: High Dose GummyExperimental Treatment1 Intervention
Participants will self-administer a gummy containing 25mg THC
Group V: High Dose ChocolateExperimental Treatment1 Intervention
Participants will self-administer chocolate containing 25mg THC
Group VI: High Dose BeverageExperimental Treatment1 Intervention
Participants will self-administer a beverage containing 25mg THC
Group VII: Placebo GummyPlacebo Group1 Intervention
Participants will self-administer a gummy containing 0mg THC
Group VIII: Placebo ChocolatePlacebo Group1 Intervention
Participants will self-administer chocolate containing 0mg THC
Group IX: Placebo BeveragePlacebo Group1 Intervention
Participants will self-administer a beverage containing 0mg THC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabis
2014
Completed Phase 3
~810

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,043 Total Patients Enrolled
28 Trials studying Cannabis Use
6,077 Patients Enrolled for Cannabis Use
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,700 Total Patients Enrolled
2 Trials studying Cannabis Use
72 Patients Enrolled for Cannabis Use
Tory Spindle, PhDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
304 Total Patients Enrolled

Media Library

Cannabis (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05602649 — Phase 1
Cannabis Use Research Study Groups: Placebo Gummy, Low Dose Gummy, High Dose Gummy, Placebo Chocolate, Low Dose Chocolate, High Dose Chocolate, Placebo Beverage, Low Dose Beverage, High Dose Beverage
Cannabis Use Clinical Trial 2023: Cannabis Highlights & Side Effects. Trial Name: NCT05602649 — Phase 1
Cannabis (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05602649 — Phase 1

Frequently Asked Questions

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

Who is the ideal cohort for this medical research endeavor?

"This research project seeks to recruit 80 individuals aged 21-55 who have had prior experience with THC-dominant cannabis. To be eligible, these prospective participants must meet the following prerequisites: Written and verbal consent, good health as determined by physical examination, vitals checks, medical history reviews and routine laboratory tests; negative results for drug use (including cannabis) and alcohol at screening sessions; females not pregnant or lactating (verified through serum pregnancy testing); BMI between 16 and 38 kg/m2; no blood donations in past 30 days."

Answered by AI

What perils might arise from consuming excessive quantities of cocoa?

"Our team at Power gauged High Dose Chocolate's safety to be a 1 on the scale of 1-3 as this is an early stage trial, which only boasts limited data regarding its efficacy and protection."

Answered by AI

Is this research still open to enrollment?

"Clinicaltrials.gov lists this particular medical research as inactive, initially posted on January 1st 2023 and last updated October 27th 2022. However, 122 additional trials are actively recruiting patients at the present moment."

Answered by AI

Are individuals aged 25 and above welcome to join this research endeavor?

"According to the study's eligibility requirements, participants must range between 21 and 55 years of age."

Answered by AI

What is the long-term objective of this clinical assessment?

"This clinical trial will assess Executive functioning over an 8 hour period through the Mean Distance from Center Target Stimulus on the Divided Attention Task (DAT). Additionally, Cannabidiol Blood concentrations are measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis and Area Under Curve (AUC), Maximum Concentration (Cmax), and Time to Max Concentration (Tmax) for 11-OH Tetrahydrocannabinol metabolite is also assessed."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles
2024. "The Impact of Product Formulation on the Pharmacokinetics and Pharmacodynamics of Cannabis Edibles". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05602649.
~53 spots leftby Jan 2026
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