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Oral Dronabinol-HIV

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ClinicalTrials.gov Identifier: NCT06034314
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : December 18, 2023
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Drug: Dronabinol Capsules Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
Actual Study Start Date : September 21, 2023
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV Marijuana
Drug Information available for: Dronabinol

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034314


Contacts
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Contact: Brooklyn A Bradley, BS 203-948-1435 bb889@yale.edu
Contact: Heather R Garrett, BS 203-505-8486 heather.garrett@yale.edu

Locations
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United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Ke Xu, MD, PhD         
Principal Investigator: Ke Xu, MD, PhD         
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Ke Xu, MD, PhD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT06034314    
Other Study ID Numbers: 2000035807
1R01DA052846-01 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists