Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT04124432
Eligibility Criteria:
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 aside from cannabis (via urine sample) and alcohol (via breath sample) at the screening visit and upon arrival for each experimental session.
* 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 not donated blood in the prior 30 days.
* Report prior experience inhaling cannabis.
* Report using cannabis at least 5 times in the past year.
* Smoke ≥5 tobacco cigarettes per day on average in the past month.
* Use an e-cigarette at least 15 of the past 30 days.
* Have a breath carbon monoxide (CO) of \>8ppm or urine cotinine \>200ng/mL to confirm current nicotine use status.
Exclusion Criteria:
* Non-medical use of psychoactive drugs (aside from cannabis) other than, nicotine, alcohol, or caffeine in the month prior to the Screening Visit;
* History of or current evidence of significant medical or psychiatric illness which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the subject.
* 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 results 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 results or the safety of the subject.
* 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.
* Epilepsy or a history of seizures.
* Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician
* Individuals with anemia.
* Prior history of allergic or serious adverse reaction to either cannabis or tobacco/nicotine.
* Average use of cannabis more than 2 times per week in the prior 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04124432
Study Brief:
Protocol Section:
NCT04124432