Status:
NOT_YET_RECRUITING
Behavioral Pharmacology of THC and Beta-Myrcene
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.
Detailed Description
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). Participants will complete 9 acute drug administration periods in which they will administer THC...
Eligibility Criteria
Inclusion
- 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 vapor (delta 9-THC, myrcene).
- Demonstrate competency on cognitive performance measures at screening visit (e.g., PASAT score over 75).
Exclusion
- 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 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 5 half-lives for that specific drug; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.
- Cannabis use that is inconsistent with protocol requirements.
- Clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).
- Individuals with anemia or who have donated blood in the prior 30 days
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05432284
Start Date
January 1 2026
End Date
November 1 2027
Last Update
September 25 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224