INTERVENTIONALACTIVE NOT RECRUITINGNCT06034314
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2025-11-05
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE1
- Enrollment
- 160 (ESTIMATED)
- Start date
- 2023-09-21
- Sponsor
- Yale University
- Design
- NON RANDOMIZED · PARALLEL · OTHER
- Locations
- 1
- Results record
- Not present in registry snapshot
HIV
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
Interventions
What was registered
DRUGDronabinol Capsules
Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.
Marinol · Syndros Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Healthy volunteers
- Accepted
Eligibility criteria
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).
primary outcomes
primary measures
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.
secondary outcomes
secondary measures
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
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.
Identification of Dronabinol related cellular gene networks in blood samples
Time frame: up 5 years
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.
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- c53db9b3-7d54-43f6-bcf3-aefc7fbedcdd
- Retrieved
- 11/09/2026, 14:54:46
- SHA-256
- 8a241703a9826b5e1dc10b5ab7c2f39751dc7a94a97d1dbcd36baeffdbfd77b4