Dronabinol Effects on THC Metabolism During Pregnancy
(PrECEPT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications or supplements that affect certain liver enzymes (CYP2C9, CYP3A4, or UGT) at least 1 month before participating. If you're on prescription drugs that affect these enzymes, you won't be eligible to join the study.
Is Dronabinol (THC) safe to use during pregnancy?
Research suggests that using THC during pregnancy can have harmful effects on both the mother and the baby, including psychiatric issues for the mother and heart rhythm problems, growth restrictions, and birth defects for the baby. It is important to be cautious and consult with a healthcare provider before using THC during pregnancy.12345
How does the drug Dronabinol differ from other treatments for THC metabolism during pregnancy?
Dronabinol, a synthetic form of THC, is unique because it specifically targets the endocannabinoid system, which plays a crucial role in pregnancy. Unlike other treatments, it may alter the expression of enzymes involved in endocannabinoid metabolism, potentially affecting placental development and fetal growth.678910
What is the purpose of this trial?
Cannabis use is prevalent among pregnant women, but the effects of use on both the developing fetus and pregnant woman are unknown. Importantly, drug exposure could be influenced by the impact of pregnancy-associated hormones on the metabolism of tetrahydrocannabinol (THC), the main psychoactive component of cannabis. The goal of this study is to determine whether cortisol and estradiol - hormones that rise dramatically during pregnancy - increase the clearance of dronabinol (THC) in reproductive age women to simulate the pregnant state. The collected data will then be used to predict the time course and magnitude of changes in THC metabolism in pregnant women, particularly with gradually increasing estradiol and cortisol concentrations that evolve over the course of pregnancy. The overall objective of this study is to better understand the effects of THC use during pregnancy on the health of the pregnant woman and developing fetus.
Research Team
Nina Isoherranen, PhD
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for healthy, premenopausal women aged 21-45 with a BMI under 30. Participants should have regular menstrual cycles and agree to use nonhormonal contraception. Exclusions include history of blood clots, cancer, severe hypertriglyceridemia, uncontrolled hypertension, anemia, certain medication use (including hormonal contraceptives), current pregnancy or lactation, allergies to study drugs or sesame oil, psychiatric illness history, systemic diseases like auto-immune disorders or extensive skin disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Estradiol Treatment
Participants receive 0.3 mg/24 hr transdermal estradiol for 1 week
Cortisol Treatment
Participants receive 30 mg hydrocortisone daily, administered in 2 divided doses for 1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dronabinol
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?
University of Washington
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator