Oral Dronabinol-HIV

Yale University

Status and phase: Active, not recruiting; Phase 1

Conditions: HIV

Treatments: Drug: Dronabinol Capsules

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06034314

2000035807

1R01DA052846-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

People with HIV (PWH) with Cannabis use

Experimental group

Description:

PWH with cannabis use

Treatment:

Drug: Dronabinol Capsules

People without HIV (PWoH) with Cannabis use

Experimental group

Description:

PWoH with Cannabis use

Treatment:

Drug: Dronabinol Capsules