NCT06034314Active, not recruitingPhase 1
Oral Dronabinol-HIV
Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
The purpose of this study is to define the mechanisms of cannabis on the genome of people with HIV who use cannabis. The investigator aims to better understand the effect of Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status dependent. This research may better inform public health policy regarding cannabis use. Depending on the results, additional studies may also build upon this research to develop more effective and specific treatments for cannabis use associated disorders.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 5 Sept 2023
- Start date
- 21 Sept 2023
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT06034314
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 21 Sept 2023 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Major or clinically unstable medical conditions (e.g., myocardial infarction, hypertension, clinically significant head injury or loss of consciousness).
- Other medical, psychiatric, or psychosocial history that is deemed unsuitable for participation in study per PI.
- Sesame oil allergy.
Age
- Under the age of 18 years.
Other
- Cannabis naïve individuals.
- 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.
- IQ less than 80.
- Diagnosis of psychosis confirmed by SCID.
- Has donated blood within the last 8 weeks.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Connecticut Mental Health Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.