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ACTIVE NOT RECRUITING

NCT04374773

PHASE4

Effects of Pregnancy-associated Hormones on THC Metabolism in Women

Sponsor: University of Washington

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Estradiol and Cortisol on Marinol Metabolism

Key Details

Gender

FEMALE

Age Range

21 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-10-19

Completion Date

2025-12-31

Last Updated

2025-08-20

Healthy Volunteers

Yes

Conditions

Pregnancy Related Cannabis Use

Interventions

DRUG

Dronabinol

2.5 mg PO administered once prior to and once after 1 week of hormone therapy

Inclusion Criteria: * Healthy, premenopausal women ages 21-45 years old * Body mass index (BMI) \<30 kg/m2 * Regular menstrual periods (monthly, cycle 28-35 days in length) * Willingness to use nonhormonal methods of contraception during the study period Exclusion Criteria: * History of diabetes or significant cardiac, kidney (eGFR\<60 mL/min/1.73m2), gastrointestinal or liver disease * History of blood clots or stroke * Allergy to dronabinol, synthetic steroids, or any other chemically related drug or steroid * Current or recent ingestion (\<3 weeks) of any medication or herbal supplement known to be an inducer or inhibitor of CYP2C9, CYP3A4 or UGT. These include some anticoagulants, anti-psychotics, antibiotics, antifungal agents, antidepressants, anti-retroviral agents and herbal supplements (or other over-the-counter medications and supplements). Subjects who are taking any of these prescription drugs will not be asked to discontinue treatment but will be ineligible for study participation. Subjects taking excluded over-the-counter medications and/or supplements will be given the option of discontinuing these for 1 month prior to study participation. * Current pregnancy or lactation * History of use of illicit drugs or smoking within the last year * Any recreational or medicinal use of cannabis or other forms of THC within 3 months * Current use of amphetamines, anticholinergic drugs or antidepressants * History of seizure disorder or psychiatric illness (mania or schizophrenia; major depression within the past year or \>2 episodes lifetime) * Current use of live or live attenuated vaccines * Personal or family (1st degree relative) history of breast or ovarian cancer * Systemic disease (cancer, auto-immune disease, chronic infection, etc) * Current or recent (within 6 months) use of hormonal contraceptives * History of severe hypertriglyceridemia (\>300 mg/dL or history of acute pancreatitis) * Uncontrolled hypertension (BP\>140/90) * Allergy to sesame oil * Anemia (Hct \<34 g/dL) * Extensive skin disease (eczema, psoriasis, etc) that would preclude use of transdermal estradiol

Locations (1)

Nina Isoherranen

Seattle, Washington, United States