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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07434895
Eligibility Criteria:
Inclusion Criteria:
* English-speaking, literate adults,
* Male or female,
* Between the ages of 18-55,
* Body Mass Index from 18.5-32.0 kg/m2,
* Not currently seeking treatment for cannabis or drug use,
* Able to provide written informed consent and perform all study procedures,
* If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
* Negative urine drug test for drugs of abuse (other than cannabis) prior to every Laboratory Session, and
* Otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, and laboratory chemistries.
Exclusion Criteria:
* Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
* Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders \[e.g., asthma, COPD\]),
* Current or past history of major psychiatric disorder that would limit ability to participate in the study,
* Use of cannabis exclusively for medical reasons (no recreational use reported),
* Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours),
* Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, including potent CYP2C9, CYP3A4, or CYP2C19 inducers,
* Clinically significant abnormal ECG (as determined by study physician/cardiologist),
* Clinically significant abnormal laboratory findings,
* History of seizure disorder,
* Clinically significant history of head injuries requiring medical management or long lasting sequalae, and
* Self-report of past 30-day use of synthetic cannabis (i.e., K2, Spice).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07434895
Study Brief:
Protocol Section:
NCT07434895