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NCT04310423 · ClinicalTrials.gov registry record · Phase 2
An Inflammatory Challenge Using Endotoxin
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04310423 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 20 participants.
The verdict
NCT04310423, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The study design consists of a randomized, double-blind, placebo-controlled trial of low dose endotoxin. The low dose endotoxin challenge induces a transient systemic inflammatory response with normalization of cytokine levels within hours. This "phasic" inflammation is distinct from chronic ("tonic") levels of inflammation that may be present with AUD. A total of 38 non-treatment seeking heavy drinking men and women and 38 light drinking healthy controls will participate in the study. Recruitment will be monitored to ensure the two groups are matched by gender. Eligible participants will be randomly assigned, stratified by gender and BDI-II severity, to receive a single I.V. infusion of either low dose endotoxin (0.8 ng/kg of body weight) or placebo (same volume of 0.9% saline solution) at the UCLA Outpatient Clinical and Translational Research Center (CTRC). All participants will complete an alcohol cue-exposure paradigm and reward responsiveness assessment 2 hours post infusion, which is the time of expected peak cytokine response. All participants will also complete an fMRI alcohol cue-reactivity paradigm at 3 hours post infusion. Plasma levels of proinflammatory cytokines \[i.e., Interleukin-6 (IL-6) and tumor necrosis factor-α (TNF- α)\], mood, and alcohol craving, will be assessed at baseline and then hourly for four hours post infusion.
Interventions
- DRUG Placebo
- BIOLOGICAL Endotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04310423
The ClinicalTrials.gov registry entry for NCT04310423 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04310423 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04310423 about?
NCT04310423 is a clinical study titled "An Inflammatory Challenge Using Endotoxin". The study design consists of a randomized, double-blind, placebo-controlled trial of low dose endotoxin. The low dose endotoxin challenge induces a transient systemic inflammatory response with normalization of cytokine levels within hours. This "phasic" inflammation is distinct from chronic ("tonic...
What is the current status of trial NCT04310423?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-10-19. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT04310423?
The interventions under investigation include: Placebo (DRUG), Endotoxin (BIOLOGICAL).
Who is sponsoring clinical trial NCT04310423?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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