Investigating the effects of Dronabinol on HIV patients who use cannabis
Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
This study is testing how a cannabis-based medication called Dronabinol affects the immune system in people with HIV who use cannabis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06034314 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how Dronabinol, a cannabis-derived medication, affects the immune and inflammatory responses in individuals living with HIV who have a history of cannabis use. By analyzing the genomic mechanisms involved, the research seeks to determine if these effects vary based on HIV status. The findings may inform public health policies regarding cannabis use and could lead to the development of targeted treatments for cannabis-related disorders in HIV-positive patients.
Who should consider this trial
Good fit: Ideal candidates include HIV-positive individuals on antiretroviral therapy who have a history of cannabis use and meet specific health criteria.
Not a fit: Patients who are cannabis naïve or under the age of consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for HIV patients who use cannabis, enhancing their overall health outcomes.
How similar studies have performed: While there is ongoing research into cannabis effects on various health conditions, this specific approach focusing on HIV and Dronabinol is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
PWH Inclusion Criteria: * Current or past Cannabis use. * HIV-positive on antiretroviral therapy. * Meet criteria of viral suppression (viral load less than approximately 400 copies/ml). * Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs. * Women of Childbearing Potential: Must agree to use or have their partner use one acceptable method of birth control throughout the study, at the discretion of the principal investigator. PWoH Inclusion Criteria: * Current or past Cannabis use. * Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs. * Women of Childbearing Potential: Must agree to use or have their partner use one acceptable method of birth control throughout the study, at the discretion of the principal investigator. Exclusion Criteria: * Cannabis naïve individuals. * Under the age of 18 years. * Unable to provide written informed consent. * Unable to read or write in English. * Unable to tolerate the effects of smoking approximately half a joint of cannabis (or equivalent), at the discretion of the principal investigator. * Major or clinically unstable medical conditions (e.g., myocardial infarction, hypertension, clinically significant head injury or loss of consciousness). * IQ less than 80. * Diagnosis of psychosis confirmed by SCID. * Other medical, psychiatric, or psychosocial history that is deemed unsuitable for participation in study per PI. * Has donated blood within the last 8 weeks. * Sesame oil allergy. * Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants). * Patients with cardiac disorders or concomitant use of other drugs that are associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants). * Patients with a history of seizures, including those receiving anti-epileptic medication or with other factors that can lower the seizure threshold.
Where this trial is running
New Haven, Connecticut
- Connecticut Mental Health Center — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Ke Xu, MD, PhD — Yale University
- Study coordinator: Brooklyn A Bradley, BS
- Email: bb889@yale.edu
- Phone: 203-948-1435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.