Pharmacokinetic Study for IV Allopregnanolone

Phase 2TerminatedNCT04468360

Boston University11 enrolled

Overview

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. 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pharmacokinetic Study Post Traumatic Stress Disorder

Interventions

PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.DRUG

For the PK-2 group, after the 30-minute drug infusion of IV allopregnanolone, the IV allopregnanolone was discontinued and only normal saline was continued for the next 4-5 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 requiring clinical intervention to maintain safety * Unstable medical condition or condition that may affect outcomes * Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable; moderate TBI allowed for PK study) * 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. * Unable to tolerate IV placement or blood drawing by needle stick * Wear hearing aids or fail hearing test (not applicable to PK study) * 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

Outcomes

Primary Outcomes

Clinician Assessed Sedation Levels for Each Participant

Sedation levels will be assessed with the Qualitative Sedation Rating Scale. It has 5 categories: None- responds normally to verbal commands, cognitive \& coordination not impaired, ventilatory \& cardiovascular functions unaffected; Minimal- responds normally to verbal commands, unaffected ventilatory \& cardiovascular functions, mild feelings of intoxication, cognitive function \& coordination may be impaired; Moderate-responds purposefully to commands alone or with light touch, protective airway reflexes \& adequate ventilation maintained without intervention, cardiovascular function remains stable; Deep- cannot be easily aroused but responds purposefully to noxious stimulation, assistance may be needed to ensure the airway is protected \& adequate ventilation maintained, cardiovascular function is usually stable; Dissociative- trance-like cataleptic state with profound analgesia \& amnesia, airway protective reflexes, spontaneous respirations \& cardiopulmonary stability retained.