NCT04920539|CompletedPhase 1FDA Drug
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Sponsor study identifier
Secondary identifiers
NIH
interventional
56
1 country
1
Study Start
February 8, 2022
Actual (reported)Primary Completion
December 1, 2025
Actual (reported)Study Completion
December 30, 2025
Actual (reported)In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterations differ between HIV-infected and HIV-uninfected host genomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2021
Actual (reported)June 10, 2021
Actual (reported)February 8, 2022
Actual (reported)December 1, 2025
Actual (reported)December 30, 2025
Actual (reported)Change in Gene Expression Alteration
Quantity of each gene is measured via sequence transcriptome, and significant differences of quantified gene pre- and post-THC infusion will be identified as THC-induced gene expression alteration.
Blood samples will be collected to measure changes in gene expression altered by THC before study drug infusion and at 70, 140, and 300 minutes after study drug infusion.
Change in Cytokine Profile
Cytokine profile will be measured using Luminex Performance Human Cytokine Discovery panel before and after study drug infusion. The 45 cytokines selected based on their established role in immune functioning are: CCL2/MCP-1, CCL3/MIP-1a, CCL4/MIP-1b, CCL5/RANTES, CCL11/Eotaxin, CCL19/MIP-3b, CCL20/MIP-3a, TNFSF5, CX3CL1/Fractalkine, CXCL1/GROa, CXCL2/GROb, CXCL10/IP-10, EGF, FGF2, FLT3L, G-CSF, GM-CSF, Granzyme B, IFN-a2, IFN-b, IFN-g, IL-1a, IL-1b, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-17E, IL-33, PD-L1, PDGF-AA, PDGF-AB/BB, TGF-a, TNF-a, TNFSF10, VEGF.
Blood samples will be collected to measure changes in cytokine profile before study drug infusion and at 70, 140, and 300 minutes after study drug infusion.
Change in Gene Expression Alteration by THC between HIV-positive and HIV-negative Groups
Quantity of each gene is measured via sequence transcriptome, and significant differences of quantified gene pre- and post-THC infusion are identified as THC-induced gene expression alteration. Results will be compared between HIV-positive and HIV-negative subjects.
Blood samples will be collected to measure change in gene expression altered by THC before study drug infusion and at 70, 140, and 300 minutes after study drug infusion.
Perceptual Alterations
Perceptual alterations will be measured before study drug infusion and 70, 140, and 300 minutes after study drug infusion.
Cannabis Subjective Effects
Cannabis subjective effects will be measured before study drug infusion and 70, 140, and 300 minutes after study drug infusion.
Cannabinoid Relevant Molecules
Blood will be collected before study drug infusion and at 70, 140, and 300 minutes after study drug infusion.
Change in total immediate recall on the RAVLT.
The RAVLT will be administered prior to study drug administration at approximately 25 minutes after study drug administration.
Active Delta-9-THC (0.03 mg/kg) administered intravenously.
Active Delta-9-THC (0.03 mg/kg) administered intravenously.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Deepak C D'Souza, MD
Yale University Professor of Psychiatry
56 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2021
First Posted
June 10, 2021
Study Start
February 8, 2022
Actual (reported)The Effect of Milk Thistle on the Pharmacokinetics of Indinavir
Change in Cytokine Profile by THC between HIV-positive and HIV-negative Groups
Cytokine profile will be measured using Luminex Performance Human Cytokine Discovery panel before and after study drug infusion. Results will be compared between HIV-positive and HIV-negative subjects. The 45 cytokines selected based on their established role in immune functioning are: CCL2/MCP-1, CCL3/MIP-1a, CCL4/MIP-1b, CCL5/RANTES, CCL11/Eotaxin, CCL19/MIP-3b, CCL20/MIP-3a, TNFSF5, CX3CL1/Fractalkine, CXCL1/GROa, CXCL2/GROb, CXCL10/IP-10, EGF, FGF2, FLT3L, G-CSF, GM-CSF, Granzyme B, IFN-a2, IFN-b, IFN-g, IL-1a, IL-1b, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 p70, IL-13, IL-15, IL-17A, IL-17E, IL-33, PD-L1, PDGF-AA, PDGF-AB/BB, TGF-a, TNF-a, TNFSF10, VEGF.
Blood samples will be collected to measure changes in cytokine profile by THC before study drug infusion and at 70, 140, and 300 minutes after study drug infusion.
Contact the study team to confirm eligibility.
Primary Completion
December 1, 2025
Actual (reported)Study Completion
December 30, 2025
Actual (reported)Last Updated
February 27, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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