Pregnancy RelatedPhase 4PrECEPTNCT04374773
Effects of Pregnancy-associated Hormones on THC Metabolism in Women
A Phase 4 study testing Dronabinol in people with Pregnancy Related and Cannabis Use, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Cannabis Use
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Estradiol and Cortisol on Marinol Metabolism
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.
Read the 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 recreational cannabis use and increased use among pregnant women, there is new urgency to understand the dose-exposure relationship for THC, the mechanisms by which THC is eliminated from the body, and the impact of the hormonal milieu of pregnancy on these mechanisms. As approximately 4% of all pregnant women in the United States use cannabis, there is a critical need for studies evaluating how cannabis metabolism may change during pregnancy leading to altered exposures, pharmacology, and toxicology. Recent studies suggest that cannabis exposure during pregnancy may adversely affect the developing fetus, and administration of cannabis [or dronabinol (THC)] to pregnant women is therefore not ethical. Analysis of THC exposures and effects during pregnancy is significantly hindered by the lack of accurate, quantitative biomarkers of THC exposure and the unreliable self-report of cannabis use. To address these gaps, the current study is designed to 1) characterize the dose-exposure relationship of THC and its major metabolites 11-OH-THC and 11-nor-carboxy-THC in reproductive age women following consumption of dronabinol orally and 2) to determine how THC metabolism is altered by the pregnancy-associated hormones estradiol and cortisol. Existing data show that THC and its major metabolites are cleared by metabolizing enzymes whose activity increases during pregnancy and further has been shown to be induced specifically by estradiol and cortisol, hormones that are markedly increased during pregnancy. Based on these data, we hypothesize that increasing estradiol and cortisol concentrations during pregnancy will increase the clearance of THC and its metabolites, leading to an altered metabolism in pregnant women when compared to non-pregnant individuals. Our clinical study seeks to determine the magnitude of changes in THC pharmacokinetics in healthy female volunteers following exposures to increased estradiol and cortisol. We predict that increased estradiol and cortisol concentrations will result in induction of THC-metabolizing enzymes in the liver and intestine, resulting in increased clearance of THC and its metabolites. The clinical study will provide the foundation for modeling and simulation of THC disposition during human pregnancy. These studies will also provide seminal data to allow modeling of the THC metabolome in human plasma and urine as a function of THC dose and time after consumption, making a significant impact on development of reliable biomarkers of THC exposures in humans.
- Conditions
- Pregnancy Related, Cannabis Use
- Being tested
- Dronabinol
- Keywords
- Pregnancy, cannabis, THC, estradiol, cortisol, women
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called THC, tetrahydrocannabinol
2.5 mg PO administered once prior to and once after 1 week of hormone therapy
| Study group | Role | What they receive |
|---|---|---|
| Estradiol | Experimental | 1 week treatment with 0.3 mg/24 hr transdermal estradiol Receives: Drug: Dronabinol |
| Cortisol | Experimental | 1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses Receives: Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (3)
THC Primary Metabolite Exposure
Area under plasma concentration-time curve (AUC) for 11-OH-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
Measured: 24 hours
THC Secondary Metabolite Exposure
Area under plasma concentration-time curve (AUC) for 11-nor-COOH-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
Measured: 24 hours
Pharmacologic Effects of THC
Visual analog scale ratings of subjective 'high'. The participants self rated how they feel based on the statement from 1-6, where 6 indicates "extremely" or "least false" and 1 is "not at all".
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start19 Oct 2020
- Primary completion14 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Standard drug-drug interaction study consisting of two arms with randomized, open-label, two period crossover design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nina Isoherranen, University of Washington
- Investigators
- Nina Isoherranen, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374773
- Sponsor's protocol ID
- STUDY00008064
- Other IDs
- 2P01DA032507-06A1
- Acronym
- PrECEPT
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2020
- Last updated
- 6 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Estradiol and Cortisol on Marinol Metabolism
- ClinicalTrials.gov ID
- NCT04374773
- Acronym / sponsor ID
- PrECEPT / STUDY00008064
- Conditions
- Pregnancy Related, Cannabis Use
- Keywords
- Pregnancy, cannabis, THC, estradiol, cortisol, women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 14 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 recreational cannabis use and increased use among pregnant women, there is new urgency to understand the dose-exposure relationship for THC, the mechanisms by which THC is eliminated from the body, and the impact of the hormonal milieu of pregnancy on these mechanisms. As approximately 4% of all pregnant women in the United States use cannabis, there is a critical need for studies evaluating how cannabis metabolism may change during pregnancy leading to altered exposures, pharmacology, and toxicology. Recent studies suggest that cannabis exposure during pregnancy may adversely affect the developing fetus, and administration of cannabis [or dronabinol (THC)] to pregnant women is therefore not ethical. Analysis of THC exposures and effects during pregnancy is significantly hindered by the lack of accurate, quantitative biomarkers of THC exposure and the unreliable self-report of cannabis use. To address these gaps, the current study is designed to 1) characterize the dose-exposure relationship of THC and its major metabolites 11-OH-THC and 11-nor-carboxy-THC in reproductive age women following consumption of dronabinol orally and 2) to determine how THC metabolism is altered by the pregnancy-associated hormones estradiol and cortisol. Existing data show that THC and its major metabolites are cleared by metabolizing enzymes whose activity increases during pregnancy and further has been shown to be induced specifically by estradiol and cortisol, hormones that are markedly increased during pregnancy. Based on these data, we hypothesize that increasing estradiol and cortisol concentrations during pregnancy will increase the clearance of THC and its metabolites, leading to an altered metabolism in pregnant women when compared to non-pregnant individuals. Our clinical study seeks to determine the magnitude of changes in THC pharmacokinetics in healthy female volunteers following exposures to increased estradiol and cortisol. We predict that increased estradiol and cortisol concentrations will result in induction of THC-metabolizing enzymes in the liver and intestine, resulting in increased clearance of THC and its metabolites. The clinical study will provide the foundation for modeling and simulation of THC disposition during human pregnancy. These studies will also provide seminal data to allow modeling of the THC metabolome in human plasma and urine as a function of THC dose and time after consumption, making a significant impact on development of reliable biomarkers of THC exposures in humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Standard drug-drug interaction study consisting of two arms with randomized, open-label, two period crossover design
| Arm | Type | Receives |
|---|---|---|
| Estradiol | Experimental | Drug: Dronabinol1 week treatment with 0.3 mg/24 hr transdermal estradiol |
| Cortisol | Experimental | Drug: Dronabinol1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: THC, tetrahydrocannabinol2.5 mg PO administered once prior to and once after 1 week of hormone therapy | Drug | Cortisol, Estradiol |
Primary outcome
Dronabinol Exposure
Time frame: 24 hours
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
3 secondary outcomes
THC Primary Metabolite Exposure
Time frame: 24 hours
THC Secondary Metabolite Exposure
Time frame: 24 hours
Pharmacologic Effects of THC
Time frame: 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Isoherranen, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronabinol in people with Pregnancy Related and Cannabis Use, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dronabinol Exposure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.