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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 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 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2025-08-04 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07079761
The ClinicalTrials.gov registry entry for NCT07079761 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,116-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (91% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 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 5 interventions - of which Experiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigm is the first listed.
NCT07079761 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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