Status:
ACTIVE_NOT_RECRUITING
Oral Dronabinol-HIV
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 i...
Eligibility Criteria
Inclusion
- PWH
- 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
- 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
- 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.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06034314
Start Date
September 21 2023
End Date
October 1 2028
Last Update
November 5 2025
Active Locations (1)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06511