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Allopregnanolone for PTSD Memory Processing

This study is testing if a drug called Allopregnanolone (Allo) can help people with Post Traumatic Stress Disorder (PTSD) better process traumatic memories. Allo is a natural hormone that may help regulate stress responses and memory. Researchers will give participants Allo or a matching placebo (an inactive substance) through an IV after a memory exercise. The study aims to see if Allo helps improve how well people forget fearful memories (extinction retention) or prevents traumatic memories from becoming stronger (reconsolidation blockade). You may be able to join if you are 18-55 years old, have chronic PTSD, and are generally healthy. The study plans to enroll 96 participants.

Study design
This interventional study involves 96 participants and compares Allopregnanolone to a placebo. Participants will be randomly assigned to receive either the active drug or the placebo.
What's involved
Participants will undergo a three-day process involving memory conditioning, extinction training, and testing. On Day 2, you will receive an IV infusion of either Allo or placebo for 4-5 hours.
Compensation
Not stated in the trial record.
Follow-up
The main outcomes are measured on Day 3, after the interventions.

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NCT07079761

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

Recruiting
PHASE2Ages 18–55InterventionalBasic science
Massachusetts General Hospital
~96 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:Experiment 1: Three-day aversive conditioning, extinction, and extinction retention testing paradigmAllopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer.Experiment 1. Three-day aversive conditioning, extinction, and extinction retention testing paradigmMatching IV PlaceboExperiment 2. Three-day aversive conditioning, reconsolidation blockade, and testing paradigm

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Experiment 1: Extinction retention
Measured over Day 3
+1 more outcome measured

Conditions

Post Traumatic Stress Disorder

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Kristen Curran
[email protected]
(617) 726-8508
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Between the ages of 18 and 55 (at time of enrollment), reproductively mature, and English speaking.
Meet criteria for chronic PTSD (i.e., CAPS-5 determined PTSD duration more than 3 months).
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.
For biological females:
Natural menstrual cycle.
If of childbearing potential, female and partner must use 2 types of effective birth control (except for hormonal contraceptives, unless IUD or a device like Nuvaring) for a week before the IV Allo or placebo infusion, and for one month after.

Exclusion

Present an imminent risk to self or others or require clinical intervention to maintain safety
Diagnosis of moderate or severe substance use disorder within three months of screening per administration of the DIAMOND substance abuse evaluation. Diagnosis of a mild substance use disorder within three months of screening will be allowed if the participant agrees to abstain from illicit drugs for one month and/or alcohol for 2 weeks prior to the experimental procedures, has a negative screening or follow-up urine toxicology and/or saliva alcohol test (if the screening test is positive), and tests negative for these substances on the morning of the experimental procedures.
Bipolar I disorder, schizophreniform disorders, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory hallucinations or negative beliefs.
History of a suicide attempt within 1 year of enrolling.
A history of severe TBI is exclusionary for the PK-1 and PK-2 studies. A history of moderate or severe TBI is exclusionary for the main studies (i.e., Expt. 1 and Expt. 2).
Diagnosis of sleep apnea
Awake resting O2 saturation \< 96%
Severe renal failure with an eGFR \<30 ml/min
Use of medications or substances (by report or toxicology testing) will be exclusionary under the following conditions:
Pregnancy (urine pregnancy tests given at each in-person session).
Breast-feeding.
Unable to tolerate IV placement or blood drawing by needle stick.
Wear hearing aid(s) (For Expt. 1 and 2, not PK studies).
Fail hearing test (For Expt. 1 and 2, not PK studies).

What this trial measures

  • Experiment 1: Extinction retentionDay 3

    Extinction retention is calculated as a) the difference between the average skin conductance response (SCR) to the first 4 aversively conditioned stimulus (CS+) trials and the average SCR to first 4 neutral conditioned stimulus (CS-) trials on Day 3 minus b) the difference between the average SCR to the last 4 CS+ trials and last 4 CS- trials on Day 2.

  • Experiment 2: Reconsolidation blockadeDay 3

    Reconsolidation blockade will be assessed by calculating the average fear potentiated startle (FPS) response to the first 4 CS+ trials on Day 3. Lower scores indicate better reconsolidation blockade.