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NCT04468360 · ClinicalTrials.gov registry record · Phase 2
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
A Phase 2 study of Post Traumatic Stress Disorder, sponsored by Boston University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 256
- Enrollment target
- 2
- Study locations
NCT04468360 is a Phase 2 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Boston University. The registered enrollment target is 256 participants, below the 1,115-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04468360, a Phase 2 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Boston University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 256 participants
- Enrollment target
- 2
- Study locations
Study Summary
Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genetics can affect treatment responses. These factors can alter brain capacities needed to reprocess traumatic memories prevent them from triggering intensely distressing, disruptive, out-of-place responses. For example, during psychotherapy for PTSD, trauma memory activation engages two competing brain processes that affect recovery: "extinction" versus "reconsolidation" of trauma-related emotional, physiological, and behavioral responses. This study tests whether a single intravenous (IV) dose of allopregnanolone (Allo) compared to placebo (which is non-active): 1. promotes consolidation of extinction learning (sub-study 1) or 2. blocks reconsolidation physiological responses triggered by aversive memories (sub-study 2). The study also tests whether Allo compared to placebo affects retention of non-aversive memories.
Conditions Studied
Interventions
- OTHER Matching IV Placebo
- BEHAVIORAL 3-day differential fear conditioning, extinction, and extinction retention testing paradigm
- DRUG Allopregnanolone (Allo) with Dexolve in 0.9% saline for injection manufactured by University of California, Davis
Study Locations (2)
Massachusetts
- Boston University School of Medicine - Boston
Michigan
- Wayne State University - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04468360
The ClinicalTrials.gov registry entry for NCT04468360 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,115-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (77% lower). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Matching IV Placebo is the first listed.
NCT04468360 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT04468360 about?
NCT04468360 is a clinical study titled "Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD". Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genet...
What is the current status of trial NCT04468360?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 256 participants. The study started on 2022-03-04. Estimated completion is 2026-12.
What conditions does trial NCT04468360 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT04468360?
The interventions under investigation include: Matching IV Placebo (OTHER), 3-day differential fear conditioning, extinction, and extinction retention testing paradigm (BEHAVIORAL), Allopregnanolone (Allo) with Dexolve in 0.9% saline for injection manufactured by University of California, Davis (DRUG).
Who is sponsoring clinical trial NCT04468360?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04468360 being conducted?
This trial has 2 study locations across Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.