12 Participants Needed

Dronabinol Effects on THC Metabolism During Pregnancy

(PrECEPT Trial)

Recruiting at 1 trial location
KR
NI
Overseen ByNina Isoherranen, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

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

NI

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

I am a healthy woman, aged 21-45, and have not gone through menopause.
Body mass index (BMI) <30 kg/m2
Willingness to use nonhormonal methods of contraception during the study period
See 1 more

Exclusion Criteria

Allergy to sesame oil
I am not allergic to dronabinol, synthetic steroids, or similar drugs.
I have a history of seizures or severe mental health issues.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Estradiol Treatment

Participants receive 0.3 mg/24 hr transdermal estradiol for 1 week

1 week
1 visit (in-person)

Cortisol Treatment

Participants receive 30 mg hydrocortisone daily, administered in 2 divided doses for 1 week

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Dronabinol
Trial Overview The study investigates how pregnancy hormones affect the body's processing of THC by using dronabinol as a stand-in for cannabis' active ingredient. It aims to simulate pregnant conditions in reproductive-age women by monitoring changes in THC metabolism influenced by increasing levels of cortisol and estradiol.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: EstradiolExperimental Treatment1 Intervention
1 week treatment with 0.3 mg/24 hr transdermal estradiol
Group II: CortisolExperimental Treatment1 Intervention
1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses

Dronabinol is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Marinol for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting
  • Sleep apnea
🇺🇸
Approved in United States as Syndros for:
  • HIV/AIDS-induced anorexia
  • Chemotherapy-induced nausea and vomiting
🇨🇦
Approved in Canada as REDUVO for:
  • 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

Trials
1,858
Recruited
2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

References

Studies on the agonistic activity of delta 9-11-tetrahydrocannabinol in mice, dogs and rhesus monkeys and its interactions with delta 9-tetrahydrocannabinol. [2013]
Effects of cannabinoids on the development of chick embryos in ovo. [2021]
Adverse events of recreational cannabis use during pregnancy reported to the French Addictovigilance Network between 2011 and 2020. [2022]
Cannabis Teratology Explains Current Patterns of Coloradan Congenital Defects: The Contribution of Increased Cannabinoid Exposure to Rising Teratological Trends. [2023]
Characterization of cannabinoid plasma concentration, maternal health, and cytokine levels in a rat model of prenatal Cannabis smoke exposure. [2023]
Impact of tetrahydrocannabinol on the endocannabinoid 2-arachidonoylglycerol metabolism: ABHD6 and ABHD12 as novel players in human placenta. [2021]
The psychoactive compound of Cannabis sativa, Δ(9)-tetrahydrocannabinol (THC) inhibits the human trophoblast cell turnover. [2015]
Comparison of pharmacological effects of tetrahydrocannabinols and their 11-hydroxy-metabolites in mice. [2019]
Effects of cannabis tetrahydrocannabinol on endocannabinoid homeostasis in human placenta. [2020]
Δ9-tetrahydrocannabinol exposure during rat pregnancy leads to symmetrical fetal growth restriction and labyrinth-specific vascular defects in the placenta. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security