Oral Dronabinol-HIV

NCT06034314 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20000358071R01DA052846-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Dronabinol-induced chromatin structure profile in blood samples using single cell (sc)ATAC-seq

  Baseline, 120 minutes post-Dronabinol and 360 minutes post-Dronabinol, up 5 years

• Identification of Dronabinol related cellular gene networks in blood samples

  up 5 years

Study Arms (2)

People with HIV (PWH) with Cannabis use

EXPERIMENTAL

PWH with cannabis use

Drug: Dronabinol Capsules

People without HIV (PWoH) with Cannabis use

EXPERIMENTAL

PWoH with Cannabis use

Drug: Dronabinol Capsules

Interventions

Dronabinol Capsules DRUG

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

Also known as: Marinol, Syndros

People with HIV (PWH) with Cannabis use; People without HIV (PWoH) with Cannabis use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Ke Xu, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)