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Cannabinoid

Cannabis Edibles for Understanding Cannabis Use Effects

Phase 1
Recruiting
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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
"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 study objectives
"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
~780

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
2,588 Previous Clinical Trials
3,328,488 Total Patients Enrolled
33 Trials studying Cannabis Use
7,316 Patients Enrolled for Cannabis Use
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,534 Total Patients Enrolled
4 Trials studying Cannabis Use
272 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
~53 spots leftby Jan 2026
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