Clinical trial NCT06034314: Oral Dronabinol-HIV
Official title: Investigation of the Effects of Cannabis on the Immune-genome in People With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: HIV
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Change in Dronabinol-induced transcriptome profile in blood using single cell (sc)RNA-seq
timeFrame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol
Secondary outcomes:
measure: Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq
timeFrame: Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years
measure: Identification of Dronabinol related cellular gene networks in blood samples
timeFrame: up 5 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Ke Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: