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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA052846-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with HIV (PWH) with Cannabis use | Experimental | PWH with cannabis use |
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| People without HIV (PWoH) with Cannabis use | Experimental | PWoH with Cannabis use |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol Capsules | Drug | Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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PWH Inclusion Criteria:
PWoH Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ke Xu, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| 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. | up 5 years |