THC Clinical Trial
Official title:
Behavioral Pharmacology of Orally Administered THC and D-limonene
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.
Status | Not yet recruiting |
Enrollment | 65 |
Est. completion date | December 31, 2027 |
Est. primary completion date | July 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Have provided written informed consent - Be between the ages of 18 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Behavioral Pharmacology Research Unit | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | 8 hours after dosing | |
Secondary | 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 | |
Secondary | 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 |
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