Oral Dronabinol-HIV

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV
• Intervention / Treatment: Drug: Dronabinol Capsules

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Connecticut Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

PWH 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).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: People with HIV (PWH) with Cannabis use; PWH with cannabis use	Drug: Dronabinol Capsules; Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.; Other Names: Marinol; Syndros
Experimental: People without HIV (PWoH) with Cannabis use; PWoH with Cannabis use	Drug: Dronabinol Capsules; Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.; Other Names: Marinol; Syndros

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ke Xu, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: 2000035807; 1R01DA052846-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No