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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.
The current clinical trial will investigate the interaction of orally administered d-limonene (limonene) and delta-9-tetrahydrocannabinol (THC). Limonene is a flavor/fragrance component common to many plants, including cannabis. The investigators have previously demonstrated that vaporized limonene can impact the acute effects of THC. The purpose of this study is to examine whether orally administered limonene modulates the acute effects of orally co-administered THC in a manner similar to when these substances are inhaled A controlled laboratory study will be completed at Johns Hopkins evaluating placebo, THC alone, and four ascending doses of d-limonene in combination with THC. Participants will be healthy adults with experience using cannabis. A total of 6 outpatient drug administration sessions will be conducted for each evaluable participant. The investigators will recruit study volunteers until 20 participants complete the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Placebo | Placebo Comparator | Placebo (cellulose), via capsule |
|
| Oral THC 30mg | Experimental | 30mg pure THC in ethanol vehicle, via capsule |
|
| Oral THC 30mg + D-Limonene 25mg | Experimental | 30mg pure THC in ethanol vehicle, via capsule 25mg pure D-Limonene, via capsule |
|
| Oral THC 30mg + D-Limonene 50mg | Experimental | 30mg pure THC in ethanol vehicle, via capsule 50mg pure D-Limonene, via capsule |
|
| Oral THC 30mg + D-Limonene 100mg | Experimental | 30mg pure THC in ethanol vehicle, via capsule 100mg pure D-Limonene, via capsule |
|
| Oral THC 30mg + D-Limonene 200mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Limonene | Drug | Oral Limonene administered via capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Drug Liking as assessed by Visual Analog Scale | Subjective drug liking 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 |
| Subjective anxiety as assessed by Visual Analog Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Austin Zamarripa, PhD | Contact | 410-550-6969 | czamarr2@jhmi.edu | |
| Lauren S Pollak, MSc | Contact | 410-550-0586 | lschoen7@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Austin Zamarripa, PhD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Behavioral Pharmacology Research Unit | Recruiting | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D000077222 | Limonene |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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Within-subjects design where participants are randomly assigned to dose conditions
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place controlled, double-blind
30mg pure THC in ethanol vehicle, via capsule 200mg pure D-Limonene, via capsule |
|
| Delta-9-THC | Drug | Oral delta-9-THC in ethanol vehicle administered via capsule |
|
|
| Placebo | Drug | Placebo (cellulose) administered via capsule |
|
Subjective anxiety 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 |
| Subjective hunger as assessed by Visual Analog Scale | Subjective hunger 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 |
| Subjective paranoia as assessed by Visual Analog Scale | Subjective paranoia 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D002186 | Cannabinoids |