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NCT05853627 · ClinicalTrials.gov registry record · Phase 4
Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery
A Phase 4 study of Stress Disorders, Post-Traumatic, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05853627 is a Phase 4 study of Stress Disorders, Post-Traumatic that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, below the 154-participant average among 64 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05853627, a Phase 4 study of Stress Disorders, Post-Traumatic, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various "amnestic" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated. Prior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of "standard" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery. Participants will be randomized to one of 2 treatment arms: STD/PPNL and MM/PPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of
Conditions Studied
Interventions
- DRUG Propranolol
- BEHAVIORAL Memory reactivation procedures
Study Locations (1)
Massachusetts
- Massachusetts General Hospital Home Base Program - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05853627
The ClinicalTrials.gov registry entry for NCT05853627 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 154-participant average among 64 other Stress Disorders, Post-Traumatic trials with a reported enrollment target (48% 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 Stress Disorders, Post-Traumatic appearing as the primary indexed condition, and to 2 interventions - of which Propranolol is the first listed.
NCT05853627 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05853627 about?
NCT05853627 is a clinical study titled "Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery". The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it...
What is the current status of trial NCT05853627?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2023-06-15. Estimated completion is 2025-06-01.
What conditions does trial NCT05853627 study?
This clinical trial studies the following conditions: Stress Disorders, Post-Traumatic.
What interventions are being tested in trial NCT05853627?
The interventions under investigation include: Propranolol (DRUG), Memory reactivation procedures (BEHAVIORAL).
Who is sponsoring clinical trial NCT05853627?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853627 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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