Trial Summary
What is the purpose of this trial?
The current clinical trial will investigate the effects of orally administered d-limonene (limonene), delta-9-tetrahydrocannabinol (THC) and the combination in healthy adult volunteers.
Research Team
AZ
Austin Zamarripa, PhD
Principal Investigator
Johns Hopkins School of Medicine
Eligibility Criteria
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.Inclusion Criteria
Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
Report having used a high THC cannabis product in the past 3 years and having experienced anxiety after consuming cannabis at least once in lifetime
Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission
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Exclusion Criteria
I have a history of serious heart rhythm problems or spasms in my blood vessels.
I haven't taken any prescription drugs in the last 14 days that could affect the study.
Average use of cannabis more than 2 times per week in the prior 3 months
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Treatment Details
Interventions
- Delta-9-THC (Cannabinoid)
- D-Limonene (Terpene)
Trial OverviewThe 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.
Participant Groups
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
Delta-9-THC is already approved in Canada for the following indications:
Approved in Canada as REDUVO for:
- HIV/AIDS-induced anorexia
- chemotherapy-induced nausea and vomiting
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Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Trials
2,366
Recruited
15,160,000+
National Institutes of Health (NIH)
Collaborator
Trials
2,896
Recruited
8,053,000+