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NCT03809546 · ClinicalTrials.gov registry record · Early Phase 1
Individual Differences in Drug Response
A Early Phase 1 study, sponsored by University of Chicago.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
NCT03809546 is a Early Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 60 participants.
The verdict
NCT03809546, a Early Phase 1 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute oral THC will be administered in a double-blind and counterbalanced design. Menstrual cycle phase will be determined using blood serum analyses of estradiol and progesterone and self-reported responses. The main hypothesis is circulating estradiol levels are associated with cardiac, neuroendocrine, and subjective THC response. The rationale for the presented work is to better understand the risks of cannabis use, in order to maximize possible medical potential and minimize public health risks. The expected outcome of this work is a deeper understanding of how circulating estradiol levels may associate with response to THC and how the physiological response is associated with the subjective response. Uncovering the individual differences in response to THC will allow for more preventive action against cannabis-induced anxiety, paranoia, and psychosis.
Interventions
- DRUG Dronabinol
- DRUG dextrose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2021-06-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03809546
The ClinicalTrials.gov registry entry for NCT03809546 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dronabinol is the first listed.
NCT03809546 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03809546 about?
NCT03809546 is a clinical study titled "Individual Differences in Drug Response". Females are increasingly using cannabis, yet remain underrepresented in preclinical and clinical cannabinoid research. This female-specific research plan will test the effects of two recreationally relevant doses of oral THC and placebo in healthy females at two phases of the menstrual cycle. Acute ...
What is the current status of trial NCT03809546?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2018-11-06. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT03809546?
The interventions under investigation include: Dronabinol (DRUG), dextrose (DRUG).
Who is sponsoring clinical trial NCT03809546?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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