Actively Recruiting
Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.
Led by Massachusetts General Hospital · Updated on 2025-11-05
96
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
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): 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
Official Title
Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18 and 55 at enrollment, reproductively mature, and English speaking
- Diagnosed with chronic PTSD lasting more than 3 months
- Generally healthy and not taking prohibited medications affecting 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
- For biological females: have a natural menstrual cycle
- For females of childbearing potential: use two effective forms of birth control (except certain hormonal contraceptives) for one week before and one month after the infusion
You will not qualify if you...
- Present an imminent risk to self or others requiring clinical intervention
- Moderate or severe substance use disorder within 3 months before screening
- Bipolar I disorder, schizophreniform disorders, or significant psychotic symptoms (excluding trauma-related hallucinations or beliefs)
- Suicide attempt within 1 year before enrollment
- History of severe traumatic brain injury for pharmacokinetic studies; moderate or severe TBI for main studies
- Diagnosis of sleep apnea
- Awake resting oxygen saturation below 96%
- Severe kidney failure with eGFR below 30 ml/min
- Use of illicit substances or certain medications that increase risk or affect results during screening or study days
- Positive urine alcohol test indicating uncontrolled alcohol use
- Use of systemic hormone therapy or contraception except hormonal IUDs or certain devices if normal ovulation confirmed
- Pregnancy or breastfeeding
- Unable to tolerate IV placement or blood draws
- Use of hearing aids or failing hearing tests for main experiments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
K
Kristen Curran
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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