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NCT07079761 · ClinicalTrials.gov registry record · Phase 2

Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.

A Phase 2 study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
Phase 2
Development phase
96
Enrollment target
1
Study location

NCT07079761: Recruiting Phase 2 study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.

NCT07079761 is a Phase 2 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 96 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07079761, a Phase 2 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
Phase 2
Development phase
96 participants
Enrollment target
1
Study location

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): promotes consolidation of extinction learning (sub-study 1) or blocks reconsolidation of 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

Extinction retention is calculated as a) the difference between the average skin conductance response (SCR) to the first 4 aversively conditioned stimulus (CS+) trials and the average SCR to first 4 neutral conditioned stimulus (CS-) trials on Day 3 minus b) the difference between the average SCR to the last 4 CS+ trials and last 4 CS- trials on Day 2.

Conditions Studied

Post Traumatic Stress Disorder

Interventions

  • BEHAVIORAL Experiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigm
  • DRUG Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer.
  • BEHAVIORAL Experiment 1. Three-day aversive conditioning, extinction, and extinction retention testing paradigm
  • OTHER Matching IV Placebo
  • BEHAVIORAL Experiment 2. Three-day aversive conditioning, reconsolidation blockade, and testing paradigm

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2025-08-04
Est. Completion 2027-04-30
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What NCT07079761 shows while recruiting

NCT07079761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (86% lower).

The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 5 interventions - of which Experiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigm is the first listed.

NCT07079761 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07079761 about?

NCT07079761 is a clinical study titled "Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone 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 NCT07079761?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2025-08-04. Estimated completion is 2027-04-30.

What conditions does trial NCT07079761 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder.

What interventions are being tested in trial NCT07079761?

The interventions under investigation include: Experiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigm (BEHAVIORAL), Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer. (DRUG), Experiment 1. Three-day aversive conditioning, extinction, and extinction retention testing paradigm (BEHAVIORAL), Matching IV Placebo (OTHER), Experiment 2. Three-day aversive conditioning, reconsolidation blockade, and testing paradigm (BEHAVIORAL).

Who is sponsoring clinical trial NCT07079761?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07079761 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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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 NCT07079761's enrollment target sits among peer trials

96 116th of 262 higher than 146 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 NCT07079761

Source: ClinicalTrials.gov NCT07079761, the US trial registry maintained by the National Library of Medicine. NCT07079761 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.