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NCT04374773 · ClinicalTrials.gov registry record · Phase 4
Effects of Pregnancy-associated Hormones on THC Metabolism in Women
A Phase 4 study of Pregnancy Related and Cannabis Use, sponsored by University of Washington.
- Active
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04374773: Active Phase 4 study of Pregnancy Related and Cannabis Use, sponsored by University of Washington.
NCT04374773 is a Phase 4 study of Pregnancy Related and Cannabis Use that is active but no longer recruiting, run by University of Washington. The registered enrollment target is 12 participants, below the 1,963-participant average among 99 other Pregnancy Related trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04374773, a Phase 4 study of Pregnancy Related and Cannabis Use, is active but no longer recruiting, sponsored by University of Washington.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Dronabinol
Study Locations (1)
Washington
- Nina Isoherranen - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
What the registry record for NCT04374773 still lists
NCT04374773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,963-participant average among 99 other Pregnancy Related trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which Dronabinol is the first listed.
NCT04374773 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04374773 about?
NCT04374773 is a clinical study titled "Effects of Pregnancy-associated Hormones on THC Metabolism in Women". 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 com...
What is the current status of trial NCT04374773?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2020-10-19. Estimated completion is 2025-12-31.
What conditions does trial NCT04374773 study?
This clinical trial studies the following conditions: Pregnancy Related, Cannabis Use.
What interventions are being tested in trial NCT04374773?
The interventions under investigation include: Dronabinol (DRUG).
Who is sponsoring clinical trial NCT04374773?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04374773 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04374773's enrollment target sits among peer trials
12 97th of 99 higher than 2 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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