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RecruitingPhase 2NCT04468360

Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD

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Trial Parameters

ConditionPost Traumatic Stress Disorder
SponsorBoston University
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment256
SexALL
Min Age18 Years
Max Age55 Years
Start Date2022-03-04
Completion2026-12
Interventions
3-day differential fear conditioning, extinction, and extinction retention testing paradigmAllopregnanolone (Allo) with Dexolve in 0.9% saline for injection manufactured by University of California, DavisMatching IV Placebo

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Brief 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.

Eligibility Criteria

Inclusion 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 Exclusion Criteria: * 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 se

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