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Cannabinoid

Oral THC 30mg + D-Limonene 25mg for Tetrahydrocannabinol

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 hours after dosing

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My BMI is between 18 and 36.

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 hours after dosing

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Subjective Drug Effect as assessed by Visual Analog Scale

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,267 Previous Clinical Trials

14,837,542 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,221 Total Patients Enrolled

Austin Zamarripa, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

Frequently Asked Questions

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

What are the eligibility criteria for individuals interested in participating in this research project?

"Participants must possess tetrahydrocannabinol in their system and fall within the age bracket of 18 to 55 to meet eligibility criteria for this trial, which aims to enroll approximately 65 individuals."

Answered by AI

Is the clinical trial limited to participants younger than 75 years of age?

"Participants older than 18 years but younger than 55 are eligible to enroll in this study."

Answered by AI

Are there currently ongoing patient enrollments for this clinical trial?

"Information available on clinicaltrials.gov indicates that patient recruitment is not ongoing for this research. The trial was initially listed on September 1st, 2024 and last updated on April 18th, 2024. While participation is currently closed, there are alternative opportunities as there are a total of fourteen active trials enrolling participants at the moment."

Answered by AI

Has the combination of oral THC 30mg and D-Limonene 25mg been granted approval by the FDA?

"Our Power team rates the safety of Oral THC 30mg + D-Limonene 25mg at level 1 on a scale from 1 to 3. This designation is due to its Phase 1 trial status, indicating that there is minimal available data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral Pharmacology of Orally Administered THC and D-limonene

2024. "Behavioral Pharmacology of Orally Administered THC and D-limonene". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06378957.

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