Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD

Description

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

Post Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

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.

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

Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

Boston

Boston University School of Medicine, Boston, Massachusetts, United States, 02118

Detroit

Wayne State University, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Chronic Posttraumatic Stress Disorder
  • * Generally healthy and not on any prohibited medications (that could affect study outcomes)
  • * Willing to abstain from alcohol for 2 weeks and from nicotine, marijuana or illicit drugs for 4 weeks before experimental procedures and throughout the study
  • * Females: must have a menstrual cycle and not be on hormonal birth control (with a few exceptions; see below)
  • * If gender non-conforming: must not be on hormone therapy
  • * Bipolar I disorder, schizophreniform disorder, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory hallucinations or negative beliefs
  • * Moderate or severe substance use disorder within three months of screening
  • * Sleep Apnea
  • * History of a suicide attempt within 1 year of enrolling
  • * Imminent risk to self or others or require clinical intervention to maintain safety
  • * Unstable medical condition or condition that may affect outcomes
  • * Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable; moderate TBI allowed for PK study)
  • * Using any medications or substances (by self-report or toxicology testing) that may increase the risk of the side effects of IV Allo or affect the experimental results.
  • * Unable to tolerate IV placement or blood drawing by needle stick
  • * Wear hearing aids or fail hearing test (not applicable to PK study)
  • * Females: pregnant, breastfeeding, or if of childbearing potential, unwilling to use two forms of effective birth control (except for hormonal contraceptives, unless intrauterine device \[IUD\] or a device like NuvaRing) for one week before and one month after study drug administration

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston University,

Ann M Rasmusson, MD, PRINCIPAL_INVESTIGATOR, Boston University School of Medicine, Dept of Psychiatry

Study Record Dates

2024-12