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Cannabinoid

THC + D-Limonene for Heartburn

Phase 1
Waitlist Available
Led By Austin Zamarripa, 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
Have a body mass index (BMI) in the range of 18 to 36 kg/m2
Be between the ages of 18 and 55
Must not have
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina)
Individuals with anemia or who have donated blood in the prior 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours after dosing

Summary

This trial will study the effects of d-limonene, THC, and a combination of the two when taken by healthy adult volunteers.

Who is the study for?
This trial is for healthy adults who want to participate in a study examining the effects of d-limonene, THC, and their combination when taken by mouth. Specific eligibility criteria are not provided.
What is being tested?
The study is testing how orally administered d-limonene, delta-9-THC (the active ingredient in cannabis), and their combination affect individuals. Some participants will receive a placebo instead of the active substances.
What are the potential side effects?
Potential side effects may include those commonly associated with THC such as changes in mood, sensory perception, attention, memory impairment, increased heart rate and potential digestive discomfort from d-limonene.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18 and 36.
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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 have a history of serious heart rhythm problems or spasms in my blood vessels.
Select...
I have anemia or have donated blood in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours after dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjective Drug Effect as assessed by Visual Analog Scale
Secondary study objectives
Subjective Drug Liking as assessed by Visual Analog Scale
Subjective anxiety as assessed by Visual Analog Scale
Subjective hunger as assessed by Visual Analog Scale
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral THC 30mg + D-Limonene 50mgExperimental Treatment2 Interventions
30mg pure THC in ethanol vehicle, via capsule 50mg pure D-Limonene, via capsule
Group II: Oral THC 30mg + D-Limonene 25mgExperimental Treatment2 Interventions
30mg pure THC in ethanol vehicle, via capsule 25mg pure D-Limonene, via capsule
Group III: Oral THC 30mg + D-Limonene 200mgExperimental Treatment2 Interventions
30mg pure THC in ethanol vehicle, via capsule 200mg pure D-Limonene, via capsule
Group IV: Oral THC 30mg + D-Limonene 100mgExperimental Treatment2 Interventions
30mg pure THC in ethanol vehicle, via capsule 100mg pure D-Limonene, via capsule
Group V: Oral THC 30mgExperimental Treatment1 Intervention
30mg pure THC in ethanol vehicle, via capsule
Group VI: Oral PlaceboPlacebo Group1 Intervention
Placebo (cellulose), via capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Delta-9-THC
2021
Completed Early Phase 1
~70
D-Limonene
2019
N/A
~50

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,664 Total Patients Enrolled
2 Trials studying Heartburn
2,109 Patients Enrolled for Heartburn
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,566 Total Patients Enrolled
Austin Zamarripa, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
~43 spots leftby Jul 2027
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