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:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT03204305
Eligibility Criteria:
* Female, healthy adult volunteers who are either MJ users and nonusers (controls)
* 18-45 years of age
* serum creatinine and hepatic enzymes (AST, ALT) must be within the normal limits
* Women of child bearing potential must meet one of the following three criteria:
1\. negative pregnancy test by serum pregnancy test 2 .Following a reliable method of birth control 3. Agreeing to follow a reliable method of birth control during the study and for 1 month following all study procedures
Additional inclusion criteria for MJ users
* Regular MJ use
* present MJ positive urine
* meet Diagnostic and Statistical Manual, version 5 (DSM-5) criteria for cannabis use disorder (CUD)
Additional inclusion non-users
* report no MJ use
* present a MJ-negative urine
Exclusion Criteria:
* \< 5th grade reading level
* Current Diagnostic and Statistical Manual, version 5 (DSM-5) psychiatric disorder;
* Current DSM-5 alcohol or substance use disorder (excluding MJ or nicotine)
* Recent Illicit drug use or positive drug test
* Using MJ under the guidance of MD;
* History of seizures, closed head trauma;
* unstable hypertension;
* conditions preventing magnetic resonance imaging (MRI) such as implanted metal, claustrophobia, or anatomical abnormalities (e.g., enlarged ventricles, brain lesions);
* Use of medications or herbal supplements which may be counter indicated as determined by study physician
* Have had exposure to ionizing radiation that in combination with the study's estimated radiation exposure would result in a cumulative exposure that exceeds recommended exposure limits of 5 rem per year.
* Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.
* any serious medical condition in whom participation is contraindicated.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03204305
Study Brief:
Protocol Section:
NCT03204305