Dronabinol Effects Related to Cannabis Use
(THC-Gender-I Trial)
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking estrogen supplements or oral contraceptive pills.
What evidence supports the effectiveness of the drug Dronabinol?
Dronabinol, a form of THC, has shown potential benefits in managing symptoms like pain, spasticity, and appetite loss in conditions such as chronic pain, multiple sclerosis, and cancer. Studies indicate that while it can cause side effects like dizziness and dry mouth, many patients report symptom improvement, suggesting it can be an effective treatment option.12345
Is Dronabinol generally safe for human use?
Dronabinol, a cannabis-derived medicine, is generally considered to have a low risk profile with common side effects like dizziness and mood changes. Serious complications are rare, but it can affect heart rate and blood pressure, and may not be safe for people with heart issues or during pregnancy.678910
How is the drug Dronabinol different from other treatments for cannabis use?
Dronabinol, which contains delta9-tetrahydrocannabinol (THC), is unique because it acts on the cannabinoid system in the brain, specifically targeting CB1 and CB2 receptors, which can help manage symptoms like nausea and appetite loss. Unlike other treatments, it can be administered orally and has a well-documented profile for treating conditions like nausea from chemotherapy and appetite issues in HIV/AIDS patients.1112131415
What is the purpose of this trial?
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.
Eligibility Criteria
This trial is for healthy men and women who have tried cannabis at least once. Women must not be taking estrogen supplements or oral contraceptives, and participants with a sesame oil allergy cannot join. Those under major stress recently or currently are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of 10 mg Dronabinol or placebo and are monitored for acute effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dronabinol
- Placebo
Dronabinol is already approved in United States, Canada for the following indications:
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
- Sleep apnea
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
- HIV/AIDS-induced anorexia
- Chemotherapy-induced nausea and vomiting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor