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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: Completed Early Phase 1 study, sponsored by University of Chicago.
NCT03809546 is a Early Phase 1 study that has completed, run by University of Chicago. The registered enrollment target is 60 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assess six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger - Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of this instrument provides a global score of 0 to 120 or individual domain scores. Subscale scores range from 0-20. Lower scores indicate better mood state. The POMS brief form is a simple s
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 |
What the finished NCT03809546 record still lists
NCT03809546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which Dronabinol is the first listed.
NCT03809546 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03809546's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,565 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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