Oral Dronabinol-HIV

HIV Clinical Trial

Official title:

Investigation of the Effects of Cannabis on the Immune-genome in People With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06034314
• Other study ID #: 2000035807
• Secondary ID: 1R01DA052846-01
• Status: Recruiting
• Phase: Phase 1
• Start date: September 21, 2023
• Est. completion date: October 1, 2027

Study information

• Verified date: December 2023
• Source: Yale University
• Contact: Brooklyn A Bradley, BS
• Phone: 203-948-1435
• Email: bb889[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Dronabinol Capsules
Two 10 mg Dronabinol capsules will be administered orally, for a total of 20mg, on test day.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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