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Dronabinol for Endometriosis
Hosuton, TX
Phase 2
Waitlist Available
Led By Christopher Verrico, PhD in Pharmacology
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Due to the inability to translate patient facing documents into various languages we will only recruit English speaking participants
For females of reproductive potential: currently practicing an effective form of two types of birth control
Must not have
Known allergic reactions to cannabis, CBD, THC, or components of the study interventions
Current and unwilling to stop use of cannabis/marijuana and any other cannabinoids (CBD), including over the counter CBD products
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8-weeks
Summary
"This trial will test if Marinol, a synthetic form of THC, can help treat chronic pelvic pain in women with endometriosis. The study will involve 75 participants who will be randomly assigned
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Who is the study for?
This trial is for up to 75 individuals with chronic pelvic pain due to endometriosis. Participants will be randomly assigned in a 2:1 ratio to receive either the study drug or a placebo, without knowing which one they are getting.Check my eligibility
What is being tested?
The DARP study tests if dronabinol (synthetic THC) can reduce endometriosis-associated chronic pelvic pain. Participants will take up to 30 mg/day of this oral medication or a placebo over an eight-week period at Texas Children's Hospital.See study design
What are the potential side effects?
Potential side effects of dronabinol may include dizziness, dry mouth, mood changes, and increased heart rate. However, the specific side effects experienced by participants in this trial will help determine the safety profile of THC for future studies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fluent in English.
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I am using two effective birth control methods.
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I can take pills as directed.
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I am a woman aged between 18 and 64.
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I have had chronic endometriosis pain for at least 3 months.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to cannabis, CBD, THC, or similar substances.
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I currently use cannabis or CBD products and do not want to stop.
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I am not taking any medications that could interfere with the study.
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I use opioids daily for a chronic pain condition other than endometriosis.
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I have or might have breast cancer based on a physical exam.
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I am using a birth control implant that contains progestin.
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My BMI is over 35.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 8-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Intensity
Safety Analysis
Secondary study objectives
Analgesic Use Log
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Profile of Mood States (POMS questionnaire)
+1 moreSide effects data
From 2019 Phase 4 trial • 46 Patients • NCT0300800513%
Nausea and Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dronabinol Cap 5 Milligrams (MG)
Placebo Oral Capsule
Dronabinol Cap 10 Milligrams (MG)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DronabinolExperimental Treatment1 Intervention
Dronabinol capsules, over-encapsulated with filler to match the appearance of the placebo capsule, up to 15 mg, twice per day for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Capsules with placebo (i.e., cellulose filler), twice per day for 8 weeks.
Find a Location
Closest Location:Baylor College of Medicine· Hosuton, TX· 938 miles
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,040 Previous Clinical Trials
6,030,543 Total Patients Enrolled
1 Trials studying Endometriosis
60 Patients Enrolled for Endometriosis
Christopher Verrico, PhD in PharmacologyPrincipal InvestigatorBaylor College of Medicine