Oral Dronabinol-HIV

NCT ID: NCT06034314

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2028-10-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

People with HIV (PWH) with Cannabis use

PWH with cannabis use

Group Type: EXPERIMENTAL

Dronabinol Capsules

Intervention Type: DRUG

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

People without HIV (PWoH) with Cannabis use

PWoH with Cannabis use

Group Type: EXPERIMENTAL

Dronabinol Capsules

Intervention Type: DRUG

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

Interventions

Dronabinol Capsules

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

Intervention Type: DRUG

Other Intervention Names

Marinol; Syndros

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ke Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R01DA052846-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000035807

Identifier Type: -

Identifier Source: org_study_id