Status:
ACTIVE_NOT_RECRUITING
Effects of Pregnancy-associated Hormones on THC Metabolism in Women
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Pregnancy Related
Cannabis Use
Eligibility:
FEMALE
21-45 years
Phase:
PHASE4
Brief 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 preg...
Detailed Description
Tetrahydrocannabinol (THC) is approved as a medicinal treatment under the trade name dronabinol but is also a drug of abuse when consumed as part of cannabis products. With the legalization of recreat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04374773
Start Date
October 19 2020
End Date
December 31 2025
Last Update
August 20 2025
Active Locations (1)
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1
Nina Isoherranen
Seattle, Washington, United States, 98125