Oral Dronabinol-HIV
Running, not enrolling · Phase 1
Conditions studied: HIV
In brief
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.
Key facts
- Study ID
- NCT06034314
- Run by
- Yale University
- People needed
- 160
- Starts
- 2023-09-21
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2025-11-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Connecticut Mental Health Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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