Phase 4
N=14
Effects of Pregnancy-associated Hormones on THC Metabolism in Women
Pregnancy Related · Cannabis Use
Bottom Line
View on ClinicalTrials.gov: NCT04374773 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Dronabinol Exposure — 7.0; 5.6; 5.1; 5.0 nM*h — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dronabinol (Drug)
- Age
- Adult · 21+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Feb 2026
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dronabinol Exposure |
7.0; 5.6; 5.1; 5.0 | >0.05 |
| SECONDARY THC Primary Metabolite Exposure |
13; 11; 11; 13 | >0.05 |
| SECONDARY THC Secondary Metabolite Exposure |
258; 180; 228; 226 | >0.05 |
| SECONDARY Pharmacologic Effects of THC |
1.4; 1.6; 1.4; 1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy, premenopausal women ages 21-45 years old
- Body mass index (BMI) 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
Data sourced from ClinicalTrials.gov (NCT04374773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.