Loading clinical trials...

Oral Dronabinol-HIV | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Oral Dronabinol-HIV

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

NCT06034314•Yale University

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States

Key Dates

Start Date

September 21, 2023

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2028

Last Updated

November 5, 2025

Enrollment

160

ESTIMATED participants

Conditions

HIV

Interventions

Dronabinol Capsules

DRUG

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

View study

RECRUITING

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

View study

RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Oral Dronabinol-HIV

Inclusion Criteria

Exclusion Criteria

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption