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Cannabinoid
Dronabinol Effects Related to Cannabis Use (THC-Gender-I Trial)
Phase 1
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Taking estrogen supplements or oral contraceptive pills (for women)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and +80 minutes after start of oral dronabinol administration.
Summary
This trial will help researchers understand how cannabinoids affect men and women differently and what underlying mechanisms may cause these differences.
Who is the study for?
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.
What is being tested?
The study aims to understand how cannabinoids affect men and women differently by comparing the effects of Dronabinol (a synthetic form of THC) to a placebo in healthy individuals.
What are the potential side effects?
Dronabinol can cause dizziness, dry mouth, feeling 'high', sleepiness, nausea, and sometimes confusion or hallucinations. The placebo should not cause any side effects unless there's an unexpected reaction.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking estrogen supplements or oral contraceptive pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and +80 minutes after start of oral dronabinol administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and +80 minutes after start of oral dronabinol administration.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)
Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: THCActive Control1 Intervention
10 mg Dronabinol will be administered orally.
Group II: PlaceboPlacebo Group1 Intervention
Placebo pill (no active cannabinoids).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,618 Total Patients Enrolled
14 Trials studying Cannabis
784 Patients Enrolled for Cannabis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking estrogen supplements or oral contraceptive pills.I am in good physical and mental health.
Research Study Groups:
This trial has the following groups:- Group 1: THC
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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