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Cannabinoid

Dronabinol Effects on THC Metabolism During Pregnancy (PrECEPT Trial)

Phase 4
Waitlist Available
Led By Nina Isoherranen, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy, premenopausal women ages 21-45 years old
Be between 18 and 65 years old
Must not have
Allergy to dronabinol, synthetic steroids, or any other chemically related drug or steroid
History of seizure disorder or psychiatric illness (mania or schizophrenia; major depression within the past year or >2 episodes lifetime)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved

Summary

This trial is testing whether the hormones that rise during pregnancy impact how the body metabolizes THC, the main psychoactive component in cannabis. The goal is to better understand the effects of THC use during pregnancy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Dronabinol can cause side effects similar to cannabis such as dizziness, mood changes, sleepiness or trouble sleeping; it may also lead to physical symptoms like dry mouth and eyes. The extent of these side effects during the simulated hormone conditions of pregnancy will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy woman, aged 21-45, and have not gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to dronabinol, synthetic steroids, or similar drugs.
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I have a history of seizures or severe mental health issues.
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I have recently received a live vaccine.
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I or my close family member had breast or ovarian cancer.
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I have not taken any drugs or supplements that affect certain enzymes in the last 3 weeks.
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I do not have extensive skin conditions like eczema or psoriasis.
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I have had a blood clot or stroke in the past.
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I am currently taking amphetamines, anticholinergic drugs, or antidepressants.
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My blood pressure is not higher than 140/90.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dronabinol exposure
Secondary study objectives
Pharmacologic effects of THC
THC primary metabolite exposure
THC secondary metabolite exposure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: EstradiolExperimental Treatment1 Intervention
1 week treatment with 0.3 mg/24 hr transdermal estradiol
Group II: CortisolExperimental Treatment1 Intervention
1 week treatment with 30 mg hydrocortisone daily, administered in 2 divided doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,820 Previous Clinical Trials
1,914,661 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,589 Previous Clinical Trials
3,328,505 Total Patients Enrolled
Nina Isoherranen, PhDPrincipal Investigator - University of Washington
University of Washington

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04374773 — Phase 4
Pregnancy Research Study Groups: Estradiol, Cortisol
Pregnancy Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT04374773 — Phase 4
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374773 — Phase 4
~1 spots leftby Mar 2025
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