Pharmacokinetic Study for IV Allopregnanolone
Key facts
- Who runs it
- Boston University
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 11 people enrolled
- Started
- 4 Mar 2022
- Ended
- 29 Apr 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis
- PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.
- Record updated
- 2 June 2026
- Why it stopped
- The investigator moved to another institution; only preliminary data from pharmacokinetic studies were collected at Boston University School of Medicine/Boston Medical Center.
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Using any medications or substances (per self-report or toxicology testing) that may increase the risk for IV Allo side effects or affect the experimental results
- 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
- 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
- History of a suicide attempt within 1 year of enrolling
- Unstable medical condition or condition that may affect outcomes
- Sleep Apnea
- Imminent risk to self or others or requiring clinical intervention to maintain safety
- Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable; moderate TBI allowed for PK study)
- Unable to tolerate IV placement or blood drawing by needle stick
- Wear hearing aids or fail hearing test (not applicable to PK study)
Where in United States
- Boston University Chobanian & Avedisian School of MedicineBoston, United States
About the trial
What the trial wants to find out
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 to prevent them from triggering intense, distressing, disruptive, out-of-place responses.
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Before starting the interventional study (described in detail in NCT07079761), the investigators will conduct two pharmacokinetic (PK) studies (PK-1 and PK-2) in a small group of individuals with PTSD to test dosing and safety at Boston Medical Center.
The 2 groups in the trial
- PK-1 GroupTreatment being tested
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
Treatment: PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis
- PK-2 GroupTreatment being tested
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone of 28 mcg/kg, The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
Treatment: PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD- Pharmacokinetic Studies
- Record updated
- 2 June 2026