Effects of Pregnancy-associated Hormones on THC Metabolism in Women

NCT04374773 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: STUDY000080642P01DA032507-06A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pregnancy Related; Cannabis Use

Keywords

Pregnancy, cannabis, THC, estradiol, cortisol, women

Outcome Measures

Primary Outcomes (1)

• Dronabinol Exposure

  Area under plasma concentration-time curve (AUC) for THC. For AUC calculation the time points of 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hrs post dosing were included

  24 hours

Secondary Outcomes (3)

• THC Primary Metabolite Exposure

  24 hours

• THC Secondary Metabolite Exposure

  24 hours

• Pharmacologic Effects of THC

  12 hours

Study Arms (2)

Estradiol

EXPERIMENTAL

1 week treatment with 0.3 mg/24 hr transdermal estradiol

Drug: Dronabinol

Cortisol

EXPERIMENTAL

1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses

Drug: Dronabinol

Interventions

Dronabinol DRUG

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

Also known as: THC, tetrahydrocannabinol

Cortisol; Estradiol

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Nina Isoherranen

Seattle, Washington, 98125, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Nina Isoherranen
• Organization: University of Washington

ni2@uw.edu

2065432517

Study Officials

• Nina Isoherranen, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Pharmacy

Model Details: Standard drug-drug interaction study consisting of two arms with randomized, open-label, two period crossover design

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: October 19, 2020
• Primary Completion: February 14, 2026
• Study Completion: February 28, 2026
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)