Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
NCT04468360 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 150 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04468360 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04468360?
This trial is sponsored by Boston University, which has 150 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.