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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT04800159
Eligibility Criteria:
Inclusion Criteria for Study Entry:
1. Age 18 or older;
2. Capacity to provide informed consent;
3. Presence of HIV infection by a standard diagnostic test;
4. On a stable ART regimen for at least 1 month and with a suppressed viral load by self-report;
5. Willing to abstain from cannabis for at least 24 hours prior to the Phase 1 assessment.
6. Willing to abstain from grapefruit juice consumption for 4 weeks prior to the Phase 1 assessment.
Exclusion Criteria for Study Entry:
1. Traumatic brain injury, including head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications;
2. Dementia, including Alzheimer's disease;
3. History of stroke with residual neurologic sequelae;
4. History of seizure disorder with a seizure in the past year;
5. Severe psychiatric disorder (e.g., schizophrenia) that might make the person's participation in the study unsafe;
6. Substance or alcohol use disorder in the past 3 months;
7. Contraindications to lumbar puncture for those consenting to lumbar puncture (e.g., coagulopathy).
Additional Inclusion Criteria for participation in the cannabis administration visits (Phase 2-interventional):
1. Treatment with an integrase inhibitor (i.e. dolutegravir);
2. Use of cannabis in the past 10 years without a severe adverse reaction (e.g., disorientation, paranoia, or hallucinations). The two-year cutoff is to ensure exposure to modern cannabis, which is more likely to match the drug concentrations administered in this study;
3. Willing to refrain from driving or operating heavy machinery after the visit; and
4. Willing to abstain from cannabis for at least 48 hours prior to the cannabis administration visits.
5. Willing to abstain from grapefruit juice consumption for 4 weeks prior to cannabis administration and during the administration visits
Additional Exclusion Criteria for participation in the cannabis administration visits (Phase 2-interventional):
1. Younger than 21 years due to problems with the use of cannabis in children and adolescents;
2. a respiratory condition that would be exacerbated by inhaling vaporized cannabis (e.g., asthma or chronic obstructive pulmonary disease) or limited lung capacity that would prevent the individual from performing the Foltin puff procedure;
3. History of cardiovascular disease, including myocardial infarction;
4. Uncontrolled hypertension with systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 100 mm Hg prior to study product administration;
5. Resting pulse greater than 100 beats per minute prior to study product administration;
6. Pregnancy as determined by a human chorionic gonadotropin urine test, women who are lactating, or unwillingness to prevent pregnancy during the cannabis administration portion of the study (using birth control in women of child-bearing age). Acceptable methods of birth control are: oral contraceptive pills, diaphragm, condom, progestin implant, intrauterine contraceptive device, sterilization, etc;
7. Active opportunistic infection or malignancy requiring treatment;
8. Unintentional loss of 10% or more of body weight during the previous 6 months;
9. CD4+ T-cell count less than 200 cells/µL;
10. Estimated glomerular filtration rate \< 30 mL/minute, indicative of renal dysfunction;
11. Hepatic transaminases \> 2 times the upper limit of normal;
12. Current severe depressive symptoms (BDI-II score ≥ 31) or suicidal ideation;
13. Known sensitivity to Acetaminophen (the probe for UGT activity);
14. Current use of substances that could have adverse interactions with Acetaminophen or cannabis (e.g., grapefruit juice).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04800159
Study Brief:
Protocol Section:
NCT04800159