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Cannabinoid

Dronabinol Effects on THC Metabolism During Pregnancy (PrECEPT Trial)

Q: To what ailments has Dronabinol been found to be efficacious?

<p>Dronabinol is typically used to combat <a href="https://www.withpower.com/clinical-trials/weight-loss">weight loss</a>, but can also be administered for numerous other maladies such as inadequate response to conventional therapy, pharmacotherapy and appetite decline.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

PrECEPT Trial 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.Check my eligibility

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.See study design

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.

PrECEPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

PrECEPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dronabinol exposure

Secondary outcome measures

Pharmacologic effects of THC

THC primary metabolite exposure

THC secondary metabolite exposure

PrECEPT 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,738 Previous Clinical Trials

1,844,339 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,621 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study accept participants aged over two decades?

"This medical trial requires that applicants be aged 21 to 45. There are 41 trials for minors and 154 other studies aimed at the elderly population."

Answered by AI

Are there any opportunities for volunteers to take part in this research endeavor?

"That is correct. Clinicaltrials.gov evidences that this medical experiment, which was initially posted on September 1st 2020, remains open for participants to join. The trial necessitates 12 individuals from one clinical location."

Answered by AI

Is my participation in this trial an option?

"Presently, 12 candidates who have a history of cannabis abuse are being sought after. Eligible applicants must fall in the age range 21 to 45 and meet additional requirements such as willingness to use non-hormonal contraception while participating in the trial, BMI below 30 kg/m2 ,and regular menstrual cycles (between 28 - 35 days)."

Answered by AI

What is the upper limit of participants enrolled in this scientific investigation?

"Affirmative. According to clinicaltrials.gov, this research is recruiting subjects as of now and was first published on September 1st 2020. Recently it was revised for the last time on August 10th 2022 with a focus to include 12 patients from one single medical centre."

Answered by AI

To what ailments has Dronabinol been found to be efficacious?

"Dronabinol is typically used to combat weight loss, but can also be administered for numerous other maladies such as inadequate response to conventional therapy, pharmacotherapy and appetite decline."

Answered by AI

Are there any adverse effects associated with Dronabinol consumption?

"As this drug is approved for use, the safety score of Dronabinol was evaluated as a 3 based on our team's metrics."

Answered by AI

What past experiments have been undertaken to evaluate Dronabinol?

"Currently, 38 clinical trials related to Dronabinol are in action. Of these studies, 6 have advanced to Phase 3. Across the United States of America, 90 locations are running research on this medication with a majority located in Belmont Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Pregnancy-associated Hormones on THC Metabolism in Women

Nina Isoherranen 2020. "Effects of Pregnancy-associated Hormones on THC Metabolism in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04374773.

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