Health TrialsbyHealthPanel

Behavioral Pharmacology of Orally Administered THC and D-limonene

ConditionsSubjective Drug EffectsTHCD-limonene
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorJohns Hopkins University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • D-Limonene

    Drug

    Oral Limonene administered via capsule

  • Delta-9-THC

    Drug

    Oral delta-9-THC in ethanol vehicle administered via capsule

  • Placebo

    Drug

    Placebo (cellulose) administered via capsule

Treatment groups

65 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Oral PlaceboPlacebo comparator 1 intervention
Group B: Oral THC 30mgExperimental treatment 1 intervention
Group C: Oral THC 30mg + D-Limonene 25mgExperimental treatment 2 interventions
Group D: Oral THC 30mg + D-Limonene 50mgExperimental treatment 2 interventions
Group E: Oral THC 30mg + D-Limonene 100mgExperimental treatment 2 interventions
Group F: Oral THC 30mg + D-Limonene 200mgExperimental treatment 2 interventions

Trial outcomes

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

Time frame
8 hours after dosing

Secondary outcomes

1

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

Time frame
8 hours after dosing
2

Subjective anxiety as assessed by Visual Analog Scale

Subjective anxiety will be measured on a 100 point visual analog scale (VAS) where 0 = no drug effect and 100 = strongest drug effect imaginable

Time frame
8 hours after dosing
3

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

Time frame
8 hours after dosing
4

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

Time frame
8 hours after dosing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov
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