Dronabinol Effects on THC Metabolism During Pregnancy

(PrECEPT Trial)

Not currently recruiting at 1 trial location

Overseen By Nina Isoherranen, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Washington

Must not be taking: Anticoagulants, Antipsychotics, Antidepressants, others

Disqualifiers: Diabetes, Cardiac, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pregnancy hormones such as cortisol and estradiol affect the breakdown of THC (dronabinol), the main active ingredient in cannabis. Researchers aim to understand the impact of THC use during pregnancy on both the mother and the baby. Participants will receive either a hormone treatment to mimic pregnancy conditions or a placebo. Women who may qualify have regular menstrual cycles and have not recently used cannabis or similar substances. As a Phase 4 trial, this research seeks to understand how an already FDA-approved treatment benefits more patients, providing valuable insights for expectant mothers.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications or supplements that affect certain liver enzymes (CYP2C9, CYP3A4, or UGT) at least 1 month before participating. If you're on prescription drugs that affect these enzymes, you won't be eligible to join the study.

What is the safety track record for dronabinol?

Research has shown that dronabinol, a type of THC, has been studied in various contexts, but limited information exists about its effects during pregnancy. Cannabis use during pregnancy is linked to risks like low birth weight and early birth, though these findings primarily concern cannabis in general, not specifically dronabinol.

This trial combines dronabinol with two natural pregnancy hormones, estradiol and cortisol, to examine their impact on THC processing in the body. As this trial is in a later stage, previous assessments have checked dronabinol's safety, though not specifically for pregnant women.

While the FDA has approved dronabinol for other uses, pregnancy might alter its safety profile. This study aims to understand these changes better, so potential participants should consider these factors and consult their healthcare providers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about dronabinol in the context of pregnancy because it offers a novel approach to understanding THC metabolism during this critical period. While most treatments focus on managing symptoms or conditions directly, dronabinol, a synthetic form of THC, provides insights into how THC is processed by the body during pregnancy. This could lead to more informed guidelines for cannabis use among pregnant individuals, potentially improving maternal and fetal health outcomes. Unlike traditional treatments that are symptom-focused, dronabinol's role in this study is primarily investigational, aiming to unravel the complexities of THC interaction within the pregnant body.

What evidence suggests that this trial's treatments could be effective for THC metabolism during pregnancy?

Research has shown that dronabinol, a type of THC (the main active component of cannabis), poses several risks during pregnancy. Studies have found that cannabis use during pregnancy can lead to high blood pressure, early birth, and low birth weight. Some pregnant women use cannabis to alleviate nausea and vomiting, and many report it as helpful. However, overall evidence suggests potential negative effects on both the mother and the developing baby. This trial will examine how pregnancy hormones, specifically through administering estradiol or cortisol, might alter THC processing in the body, potentially impacting these outcomes. ^{1 2 4 5 6}

Who Is on the Research Team?

Nina Isoherranen, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for healthy, premenopausal women aged 21-45 with a BMI under 30. Participants should have regular menstrual cycles and agree to use nonhormonal contraception. Exclusions include history of blood clots, cancer, severe hypertriglyceridemia, uncontrolled hypertension, anemia, certain medication use (including hormonal contraceptives), current pregnancy or lactation, allergies to study drugs or sesame oil, psychiatric illness history, systemic diseases like auto-immune disorders or extensive skin disease.

Inclusion Criteria

I am a healthy woman, aged 21-45, and have not gone through menopause.

Body mass index (BMI) <30 kg/m2

Willingness to use nonhormonal methods of contraception during the study period

Exclusion Criteria

Allergy to sesame oil

I am not allergic to dronabinol, synthetic steroids, or similar drugs.

I have a history of seizures or severe mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Estradiol Treatment

Participants receive 0.3 mg/24 hr transdermal estradiol for 1 week

1 week

1 visit (in-person)

Cortisol Treatment

Participants receive 30 mg hydrocortisone daily, administered in 2 divided doses for 1 week

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol

Trial Overview The study investigates how pregnancy hormones affect the body's processing of THC by using dronabinol as a stand-in for cannabis' active ingredient. It aims to simulate pregnant conditions in reproductive-age women by monitoring changes in THC metabolism influenced by increasing levels of cortisol and estradiol.

How Is the Trial Designed?

Group I: Estradiol Experimental Treatment 1 Intervention

1 week treatment with 0.3 mg/24 hr transdermal estradiol

Group II: Cortisol Experimental Treatment 1 Intervention

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

Dronabinol is already approved in United States, Canada for the following indications:

Approved in United States as Marinol for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting
• Sleep apnea

Approved in United States as Syndros for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Approved in Canada as REDUVO for:

• HIV/AIDS-induced anorexia
• Chemotherapy-induced nausea and vomiting

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7090387/

Marijuana Use in Pregnancy: A Review - PMC - PubMed Central The available published studies on marijuana exposure in pregnancy support some degree of developmental disruption associated with maternal marijuana use.

2. ccsa.ca ccsa.ca/sites/default/files/2022-05/CCSA-Cannabis-Use-Pregnancy-Breastfeeding-Report-2022-en.pdf

Cannabis Use During Pregnancy and Breastfeeding Summary of details from three longitudinal, prospective cohort studies evaluating outcomes of maternal cannabis use during pregnancy. Variable. Ottawa ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7021337/

Cannabis use during pregnancy and postpartum - PMC Most pregnant women using cannabis for nausea and vomiting (92%) found it “effective” or “extremely effective.” Paradoxically, marijuana use before pregnancy ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2821358

Prenatal Cannabis Use and Maternal Pregnancy Outcomes Prenatal cannabis use was associated with increased risk of gestational hypertension, preeclampsia, weight gain greater and less than guidelines, and placental ...

5. acog.org acog.org/clinical/clinical-guidance/clinical-consensus/articles/2025/10/cannabis-use-during-pregnancy-and-lactation

Cannabis Use During Pregnancy and Lactation Substance use in pregnancy, including cannabis use, has been associated with adverse outcomes such as spontaneous preterm birth, low birth weight, and ...

6. samhsa.gov samhsa.gov/substance-use/learn/marijuana/pregnancy

Marijuana During Pregnancy - Know the Risks (Weed, ... Marijuana use during pregnancy can be harmful to a baby's health and cause many serious problems, including stillbirth, preterm birth, and growth and ...