Actively Recruiting
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
Led by Boston University · Updated on 2025-04-20
256
Participants Needed
2
Research Sites
247 weeks
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic Posttraumatic Stress Disorder
- Generally healthy and not taking 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 and during the study
- Females must have a menstrual cycle and not be using hormonal birth control except specific exceptions
- Gender non-conforming participants must not be on hormone therapy
You will not qualify if you...
- Bipolar I disorder, schizophreniform disorder, or significant psychotic symptoms unrelated to trauma
- Moderate or severe substance use disorder within 3 months before screening
- Sleep apnea
- History of suicide attempt within 1 year before enrollment
- Immediate risk to self or others requiring clinical intervention
- Unstable medical conditions that may influence outcomes
- Moderate or severe traumatic brain injury (mild TBI allowed; moderate TBI allowed only for pharmacokinetic study)
- Use of medications or substances that increase side effects of IV Allo or affect study results
- Inability to tolerate IV placement or blood draws
- Wearing hearing aids or failing hearing tests (except for pharmacokinetic study)
- Females who are pregnant, breastfeeding, or unwilling to use two forms of effective birth control (except certain hormonal contraceptives) before and after drug administration
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Actively Recruiting
2
Wayne State University
Detroit, Michigan, United States, 48202
Active, Not Recruiting
Research Team
A
Ann M Rasmusson, MD
CONTACT
K
Kayla Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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