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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: Recruiting Phase 2 study of Post Traumatic Stress Disorder, sponsored by Boston University.

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 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Sedation levels will be assessed with the Qualitative Sedation Rating Scale. It has 5 categories: None- responds normally to verbal commands, cognitive \& coordination not impaired, ventilatory \& cardiovascular functions unaffected; Minimal- responds normally to verbal commands, unaffected ventilatory \& cardiovascular functions, mild feelings of intoxication, cognitive function \& coordination may be impaired; Moderate-responds purposefully to commands alone or with light touch, protective air

Conditions Studied

Post Traumatic Stress Disorder

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

FieldValue
Enrollment Target 256 participants
Start Date 2022-03-04
Est. Completion 2026-12
Phase Phase 2
Boston University

185 total trials

What NCT04468360 shows while recruiting

NCT04468360 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (61% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Post Traumatic Stress Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04468360's enrollment target sits among peer trials

256 38th of 262 higher than 225 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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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More recruiting context for NCT04468360

Source: ClinicalTrials.gov NCT04468360, the US trial registry maintained by the National Library of Medicine. NCT04468360 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.