Behavioral Pharmacology of Orally Administered THC and D-limonene

Launched by JOHNS HOPKINS UNIVERSITY · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of two substances: d-limonene, a compound found in citrus fruits, and THC, the active ingredient in cannabis, when taken by mouth. The goal is to understand how these substances affect healthy adults, particularly focusing on their subjective experiences or feelings after taking them. The study is in its early stages and hasn't started recruiting participants yet.

To be eligible for this study, participants must be between 21 and 55 years old, in good health, and have a body mass index (BMI) between 18 and 36. They should also have a history of using high THC cannabis and experiencing anxiety from it at least once. Participants will need to undergo several health checks, including blood and urine tests, and must not be pregnant or nursing. If you join, you can expect to take the substances and report how you feel, helping researchers gain insights into their effects. It's important to note that certain medical conditions, recent drug use, and other factors may disqualify potential participants to ensure safety during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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