Behavioral Pharmacology of Orally Administered THC and D-limonene
1 other identifier
interventional
65
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2024
CompletedFirst Posted
Study publicly available on registry
April 23, 2024
CompletedStudy Start
First participant enrolled
February 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 16, 2025
May 1, 2025
2.4 years
April 18, 2024
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Drug Effect as assessed by Visual Analog Scale
Subjective drug effect will be measured on a 100 point visual analog scale (VAS) where 0 = no drug effect and 100 = strongest drug effect imaginable
8 hours after dosing
Secondary Outcomes (4)
Subjective Drug Liking as assessed by Visual Analog Scale
8 hours after dosing
Subjective anxiety as assessed by Visual Analog Scale
8 hours after dosing
Subjective hunger as assessed by Visual Analog Scale
8 hours after dosing
Subjective paranoia as assessed by Visual Analog Scale
8 hours after dosing
Study Arms (6)
Oral Placebo
PLACEBO COMPARATORPlacebo (cellulose), via capsule
Oral THC 30mg
EXPERIMENTAL30mg pure THC in ethanol vehicle, via capsule
Oral THC 30mg + D-Limonene 25mg
EXPERIMENTAL30mg pure THC in ethanol vehicle, via capsule 25mg pure D-Limonene, via capsule
Oral THC 30mg + D-Limonene 50mg
EXPERIMENTAL30mg pure THC in ethanol vehicle, via capsule 50mg pure D-Limonene, via capsule
Oral THC 30mg + D-Limonene 100mg
EXPERIMENTAL30mg pure THC in ethanol vehicle, via capsule 100mg pure D-Limonene, via capsule
Oral THC 30mg + D-Limonene 200mg
EXPERIMENTAL30mg pure THC in ethanol vehicle, via capsule 200mg pure D-Limonene, via capsule
Interventions
Oral Limonene administered via capsule
Oral delta-9-THC in ethanol vehicle administered via capsule
Eligibility Criteria
You may qualify if:
- Have provided written informed consent
- Be between the ages of 21 and 55
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
- Test negative for drugs of abuse other than cannabis, including breath alcohol at the screening visit and at clinic admission
- 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.
- Have a body mass index (BMI) in the range of 18 to 36 kg/m2
- Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg
- Have no allergies to any of the ingredients used to prepare (cellulose, THC, d-limonene).
- 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.
You may not qualify if:
- Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 month prior to the Screening Visit;
- History of or current evidence of significant medical (e.g. seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.
- Use of an over the counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Average use of cannabis more than 2 times per week in the prior 3 months.
- History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.
- Individuals with anemia or who have donated blood in the prior 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Austin Zamarripa, PhD
Johns Hopkins School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- place controlled, double-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2024
First Posted
April 23, 2024
Study Start
February 14, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 16, 2025
Record last verified: 2025-05