HIVPhase 1NCT06034314
Oral Dronabinol-HIV
A Phase 1 study testing Dronabinol Capsules in people with HIV, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Dronabinol Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 1 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06511
About this study
Official title: Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
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.
- Conditions
- HIV
- Being tested
- Dronabinol Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol CapsulesDrug
Also called Marinol, Syndros
Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.
| Study group | Role | What they receive |
|---|---|---|
| People with HIV (PWH) with Cannabis use | Experimental | PWH with cannabis use Receives: Drug: Dronabinol Capsules |
| People without HIV (PWoH) with Cannabis use | Experimental | PWoH with Cannabis use Receives: Drug: Dronabinol Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
Changes at baseline, 120 minutes, and 360 minutes post oral Dronabinol. Transcriptome will be profiled by using single cell (sc)RNA-seq in blood samples. A panel of 45 cytokines and profiling of 37 immune cell types will be assessed for functional evaluation after Dronabinol administration.
Measured: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol
Secondary outcomes (2)
Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq
Changes in chromatin structure will be profiled by using (sc)ATAC-seq and capture methylome sequencing in a subset of samples from the primary outcome. The investigator expects to identify the differentially accessible regions and DNA methylation regions between pre- and post-Dronabinol administration that are correlated with Dronabinol-induced immune gene expression in each cell type.
Measured: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years
Identification of Dronabinol related cellular gene networks in blood samples
Data from scRNA-seq (Outcome 1) and scATAC-seq (Outcome 2) will be used to establish a computational strategy to identify cell type specific gene networks for Dronabinol response in PWoH and PWH samples separately and by HIV status.
Measured: up 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start21 Sep 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ke Xu, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034314
- Sponsor's protocol ID
- 2000035807
- Other IDs
- 1R01DA052846-01
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2023
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
- ClinicalTrials.gov ID
- NCT06034314
- Acronym / sponsor ID
- 2000035807
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with HIV (PWH) with Cannabis use | Experimental | Drug: Dronabinol CapsulesPWH with cannabis use |
| People without HIV (PWoH) with Cannabis use | Experimental | Drug: Dronabinol CapsulesPWoH with Cannabis use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol CapsulesAlso: Marinol, SyndrosTwo 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day. | Drug | People with HIV (PWH) with Cannabis use, People without HIV (PWoH) with Cannabis use |
Primary outcome
Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
Time frame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol
Changes at baseline, 120 minutes, and 360 minutes post oral Dronabinol. Transcriptome will be profiled by using single cell (sc)RNA-seq in blood samples. A panel of 45 cytokines and profiling of 37 immune cell types will be assessed for functional evaluation after Dronabinol administration.
2 secondary outcomes
Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq
Time frame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years
Identification of Dronabinol related cellular gene networks in blood samples
Time frame: up 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke Xu, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dronabinol Capsules in people with HIV, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq (time frame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.