Connecticut Mental Health Center
New Haven, Connecticut, 06511, United States
NCT Number: NCT06034314
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
PWH Inclusion Criteria:
PWoH Inclusion Criteria:
Exclusion criteria
Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.
Other names: Marinol, Syndros
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.
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.
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.
Yale University
Other
Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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