Pharmacokinetic StudyPhase 2NCT04468360

Pharmacokinetic Study for IV Allopregnanolone

A Phase 2 study testing PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis and PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis. in people with Pharmacokinetic Study and Post Traumatic Stress Disorder, run by Boston University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Pharmacokinetic Study, Post Traumatic Stress Disorder
What is being tested?: PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis and PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 4 Mar 2022to 29 Apr 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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 join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD- Pharmacokinetic Studies

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.

Conditions: Pharmacokinetic Study, Post Traumatic Stress Disorder
Being 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.
Keywords: Pharmacokinetic study, Allopregnanolone (Allo), Vital signs, Sedation ratings, Pulse oximeter data
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, DavisDrug
Also called U.S.P. equivalent: brexanolone (IV Allopregnanolone with Captisol) (SAGE Therapeutics)
For the PK-1 group, after the 5-minute loading dose of IV allopregnanolone, the dose was changed as prescribed to optimize the subject's target plasma allopregnanolone + pregnanolone level for the next 4-5 hours.
PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.Drug
Also called U.S.P. equivalent: brexanolone (IV allopregnanolone with Captisol) (SAGE Therapeutics)
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.

Study groups in NCT04468360
Study group	Role	What they receive
PK-1 Group	Experimental	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. Receives: Drug: 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 Group	Experimental	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. Receives: Drug: PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Blood Oxygen Saturation
Average across participants of blood oxygen saturation levels obtained via pulse oximetry (ranging from 0% to 100%) for each time point indicated.
Measured: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Respiratory Rate
Average across participants of respiratory rate for each time point indicated.
Measured: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Pulse Rate
Average across participants of pulse rate for each time point indicated.
Measured: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Diastolic Blood Pressure
Average across participants of diastolic blood pressure for each time point indicated.
Measured: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Systolic Blood Pressure
Average across participants of systolic blood pressure for each time point indicated.
Measured: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202229 Apr 2025

First posted13 Jul 2020
Study start4 Mar 2022
Primary completion29 Apr 2025
Study completion29 Apr 2025

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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Pharmacokinetic StudyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04468360
Sponsor's protocol ID: H-40643
Other IDs: R01MH122867
Status last verified: May 2026
First submitted: 8 Jul 2020
Last updated: 2 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Brunet A, Saumier D, Liu A, Streiner DL, Tremblay J, Pitman RK. Reduction of PTSD Symptoms With Pre-Reactivation Propranolol Therapy: A Randomized Controlled Trial. Am J Psychiatry. 2018 May 1;175(5):427-433. doi: 10.1176/appi.ajp.2017.17050481. Epub 2018 Jan 12.
PubMed 29325446
Debiec J, Ledoux JE. Disruption of reconsolidation but not consolidation of auditory fear conditioning by noradrenergic blockade in the amygdala. Neuroscience. 2004;129(2):267-72. doi: 10.1016/j.neuroscience.2004.08.018.
PubMed 15501585
Dunsmoor JE, Kroes MCW, Li J, Daw ND, Simpson HB, Phelps EA. Role of Human Ventromedial Prefrontal Cortex in Learning and Recall of Enhanced Extinction. J Neurosci. 2019 Apr 24;39(17):3264-3276. doi: 10.1523/JNEUROSCI.2713-18.2019. Epub 2019 Feb 19.
PubMed 30782974
Elsey JWB, Van Ast VA, Kindt M. Human memory reconsolidation: A guiding framework and critical review of the evidence. Psychol Bull. 2018 Aug;144(8):797-848. doi: 10.1037/bul0000152. Epub 2018 May 24.
PubMed 29792441
Glover EM, Jovanovic T, Mercer KB, Kerley K, Bradley B, Ressler KJ, Norrholm SD. Estrogen levels are associated with extinction deficits in women with posttraumatic stress disorder. Biol Psychiatry. 2012 Jul 1;72(1):19-24. doi: 10.1016/j.biopsych.2012.02.031. Epub 2012 Apr 12.
PubMed 22502987
Hu H, Real E, Takamiya K, Kang MG, Ledoux J, Huganir RL, Malinow R. Emotion enhances learning via norepinephrine regulation of AMPA-receptor trafficking. Cell. 2007 Oct 5;131(1):160-73. doi: 10.1016/j.cell.2007.09.017.
PubMed 17923095
Jovanovic T, Kazama A, Bachevalier J, Davis M. Impaired safety signal learning may be a biomarker of PTSD. Neuropharmacology. 2012 Feb;62(2):695-704. doi: 10.1016/j.neuropharm.2011.02.023. Epub 2011 Mar 4.
PubMed 21377482
Mamiya N, Fukushima H, Suzuki A, Matsuyama Z, Homma S, Frankland PW, Kida S. Brain region-specific gene expression activation required for reconsolidation and extinction of contextual fear memory. J Neurosci. 2009 Jan 14;29(2):402-13. doi: 10.1523/JNEUROSCI.4639-08.2009.
PubMed 19144840
Maren S. Out with the old and in with the new: Synaptic mechanisms of extinction in the amygdala. Brain Res. 2015 Sep 24;1621:231-8. doi: 10.1016/j.brainres.2014.10.010. Epub 2014 Oct 12.
PubMed 25312830
Milad MR, Orr SP, Lasko NB, Chang Y, Rauch SL, Pitman RK. Presence and acquired origin of reduced recall for fear extinction in PTSD: results of a twin study. J Psychiatr Res. 2008 Jun;42(7):515-20. doi: 10.1016/j.jpsychires.2008.01.017. Epub 2008 Feb 29.
PubMed 18313695
Milad MR, Zeidan MA, Contero A, Pitman RK, Klibanski A, Rauch SL, Goldstein JM. The influence of gonadal hormones on conditioned fear extinction in healthy humans. Neuroscience. 2010 Jul 14;168(3):652-8. doi: 10.1016/j.neuroscience.2010.04.030. Epub 2010 Apr 22.
PubMed 20412837
Monfils MH, Cowansage KK, Klann E, LeDoux JE. Extinction-reconsolidation boundaries: key to persistent attenuation of fear memories. Science. 2009 May 15;324(5929):951-5. doi: 10.1126/science.1167975. Epub 2009 Apr 2.
PubMed 19342552
Nader K, Schafe GE, Le Doux JE. Fear memories require protein synthesis in the amygdala for reconsolidation after retrieval. Nature. 2000 Aug 17;406(6797):722-6. doi: 10.1038/35021052.
PubMed 10963596
Norrholm SD, Anderson KM, Olin IW, Jovanovic T, Kwon C, Warren VT, McCarthy A, Bosshardt L, Sabree J, Duncan EJ, Rothbaum BO, Bradley B. Versatility of fear-potentiated startle paradigms for assessing human conditioned fear extinction and return of fear. Front Behav Neurosci. 2011 Nov 21;5:77. doi: 10.3389/fnbeh.2011.00077. eCollection 2011.
PubMed 22125516
Norrholm SD, Jovanovic T, Olin IW, Sands LA, Karapanou I, Bradley B, Ressler KJ. Fear extinction in traumatized civilians with posttraumatic stress disorder: relation to symptom severity. Biol Psychiatry. 2011 Mar 15;69(6):556-63. doi: 10.1016/j.biopsych.2010.09.013. Epub 2010 Oct 29.
PubMed 21035787

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD- Pharmacokinetic Studies
ClinicalTrials.gov ID: NCT04468360
Acronym / sponsor ID: H-40643
Conditions: Pharmacokinetic Study, Post Traumatic Stress Disorder
Keywords: Pharmacokinetic study, Allopregnanolone (Allo), Vital signs, Sedation ratings, Pulse oximeter data
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The investigator moved to another institution; only preliminary data from pharmacokinetic studies were collected at Boston University School of Medicine/Boston Medical Center.
Enrolment: 11 participants (actual)
Lead sponsor: Boston UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 4 Mar 2022 (actual)
Primary completion: 29 Apr 2025 (actual)
Study completion: 29 Apr 2025 (actual)
First posted: 13 Jul 2020 (actual)
Results: Posted 2 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PK-1 Group	Experimental	Drug: PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, DavisParticipants 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.
PK-2 Group	Experimental	Drug: PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, DavisAlso: U.S.P. equivalent: brexanolone (IV Allopregnanolone with Captisol) (SAGE Therapeutics)For the PK-1 group, after the 5-minute loading dose of IV allopregnanolone, the dose was changed as prescribed to optimize the subject's target plasma allopregnanolone + pregnanolone level for the next 4-5 hours.	Drug	PK-1 Group
PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.Also: U.S.P. equivalent: brexanolone (IV allopregnanolone with Captisol) (SAGE Therapeutics)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.	Drug	PK-2 Group

Primary outcome

Clinician Assessed Sedation Levels for Each Participant
Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
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.
Blood Oxygen Saturation
Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Average across participants of blood oxygen saturation levels obtained via pulse oximetry (ranging from 0% to 100%) for each time point indicated.
Respiratory Rate
Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Average across participants of respiratory rate for each time point indicated.
Pulse Rate
Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Average across participants of pulse rate for each time point indicated.
Diastolic Blood Pressure
Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Average across participants of diastolic blood pressure for each time point indicated.
Systolic Blood Pressure
Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Average across participants of systolic blood pressure for each time point indicated.

Results and safety

Results posted to the registry on 2 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PK-1 Group	6	6
PK-2 Group	5	5

Primary outcome: Clinician Assessed Sedation Levels for Each Participant

Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes. Count of participants. Unit: Participants

Measure	PK-1 Group n = 6	PK-2 Group n = 5
Pre-infusion : None	6	5
Pre-infusion : Minimal	0	0
Pre-infusion : Moderate	0	0
Pre-infusion : Deep	0	0
Pre-infusion : Dissociative	0	0
0 minutes after loading dose: None	6	5
0 minutes after loading dose: Minimal	0	0
0 minutes after loading dose: Moderate	0	0

Primary outcome: Blood Oxygen Saturation

Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes. Mean (Standard Deviation). Unit: percent oxygen saturation

Measure	PK-1 Group n = 6	PK-2 Group n = 5
Pre-infusion	98.3 (1.4)	98.6 (1.3)
0 minutes after loading dose	98.7 (1.0)	98.6 (1.7)
15 minutes after loading dose	98.5 (1.5)	99 (0.2)
30 minutes after loading dose	98.3 (1.2)	98.4 (1.7)
60 minutes after loading dose	98.5 (1.5)	98.4 (1.1)
120 minutes after loading dose	98.5 (0.8)	98.8 (1.8)
300 minutes after loading dose	98.2 (1.3)	98.6 (1.1)

Primary outcome: Respiratory Rate

Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes. Mean (Standard Deviation). Unit: respirations per minute

Measure	PK-1 Group n = 6	PK-2 Group n = 5
Pre-infusion	14.8 (3.0)	14.2 (2.7)
0 minutes after loading dose	15.5 (2.8)	15.2 (3.0)
15 minutes after loading dose	17.3 (4.1)	16.4 (0.5)
30 minutes after loading dose	15.3 (2.7)	16.4 (3.3)
60 minutes after loading dose	16.0 (2.8)	14.8 (2.7)
120 minutes after loading dose	15.7 (2.7)	14.8 (2.7)
300 minutes after loading dose	17.2 (2.7)	14.4 (1.7)

Primary outcome: Pulse Rate

Time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes. Mean (Standard Deviation). Unit: number of heart beats/minute

Measure	PK-1 Group n = 6	PK-2 Group n = 5
Pre-infusion	71.7 (9.4)	68.8 (5.1)
0 minutes after loading dose	70.2 (8.3)	66.2 (7.6)
15 minutes after loading dose	75.7 (12.9)	65.8 (1.3)
30 minutes after loading dose	72.2 (6.2)	67.8 (6.5)
60 minutes after loading dose	70.2 (6.9)	68.6 (6.6)
120 minutes after loading dose	72.7 (6.5)	70.4 (5.0)
300 minutes after loading dose	76.8 (8.4)	76.0 (4.8)

Adverse events

Time frame: 4-5 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PK-1 Group	0 of 6 (0%)	0 of 6 (0%)	0 of 6
PK-2 Group	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): Only preliminary data from pharmacokinetic studies were collected at Boston University School of Medicine/Boston Medical Center before the investigator moved to another institution where the actual research study is being conducted \[refer to NCT07079761\].

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29325446Brunet A, Saumier D, Liu A, Streiner DL, Tremblay J, Pitman RK. Reduction of PTSD Symptoms With Pre-Reactivation Propranolol Therapy: A Randomized Controlled Trial. Am J Psychiatry. 2018 May 1;175(5):427-433. doi: 10.1176/appi.ajp.2017.17050481. Epub 2018 Jan 12.
Background: PubMed 15501585Debiec J, Ledoux JE. Disruption of reconsolidation but not consolidation of auditory fear conditioning by noradrenergic blockade in the amygdala. Neuroscience. 2004;129(2):267-72. doi: 10.1016/j.neuroscience.2004.08.018.
Background: PubMed 30782974Dunsmoor JE, Kroes MCW, Li J, Daw ND, Simpson HB, Phelps EA. Role of Human Ventromedial Prefrontal Cortex in Learning and Recall of Enhanced Extinction. J Neurosci. 2019 Apr 24;39(17):3264-3276. doi: 10.1523/JNEUROSCI.2713-18.2019. Epub 2019 Feb 19.
Background: PubMed 29792441Elsey JWB, Van Ast VA, Kindt M. Human memory reconsolidation: A guiding framework and critical review of the evidence. Psychol Bull. 2018 Aug;144(8):797-848. doi: 10.1037/bul0000152. Epub 2018 May 24.
Background: PubMed 22502987Glover EM, Jovanovic T, Mercer KB, Kerley K, Bradley B, Ressler KJ, Norrholm SD. Estrogen levels are associated with extinction deficits in women with posttraumatic stress disorder. Biol Psychiatry. 2012 Jul 1;72(1):19-24. doi: 10.1016/j.biopsych.2012.02.031. Epub 2012 Apr 12.
Background: PubMed 17923095Hu H, Real E, Takamiya K, Kang MG, Ledoux J, Huganir RL, Malinow R. Emotion enhances learning via norepinephrine regulation of AMPA-receptor trafficking. Cell. 2007 Oct 5;131(1):160-73. doi: 10.1016/j.cell.2007.09.017.
Background: PubMed 21377482Jovanovic T, Kazama A, Bachevalier J, Davis M. Impaired safety signal learning may be a biomarker of PTSD. Neuropharmacology. 2012 Feb;62(2):695-704. doi: 10.1016/j.neuropharm.2011.02.023. Epub 2011 Mar 4.
Background: PubMed 19144840Mamiya N, Fukushima H, Suzuki A, Matsuyama Z, Homma S, Frankland PW, Kida S. Brain region-specific gene expression activation required for reconsolidation and extinction of contextual fear memory. J Neurosci. 2009 Jan 14;29(2):402-13. doi: 10.1523/JNEUROSCI.4639-08.2009.
Background: PubMed 25312830Maren S. Out with the old and in with the new: Synaptic mechanisms of extinction in the amygdala. Brain Res. 2015 Sep 24;1621:231-8. doi: 10.1016/j.brainres.2014.10.010. Epub 2014 Oct 12.
Background: PubMed 18313695Milad MR, Orr SP, Lasko NB, Chang Y, Rauch SL, Pitman RK. Presence and acquired origin of reduced recall for fear extinction in PTSD: results of a twin study. J Psychiatr Res. 2008 Jun;42(7):515-20. doi: 10.1016/j.jpsychires.2008.01.017. Epub 2008 Feb 29.
Background: PubMed 20412837Milad MR, Zeidan MA, Contero A, Pitman RK, Klibanski A, Rauch SL, Goldstein JM. The influence of gonadal hormones on conditioned fear extinction in healthy humans. Neuroscience. 2010 Jul 14;168(3):652-8. doi: 10.1016/j.neuroscience.2010.04.030. Epub 2010 Apr 22.
Background: PubMed 19342552Monfils MH, Cowansage KK, Klann E, LeDoux JE. Extinction-reconsolidation boundaries: key to persistent attenuation of fear memories. Science. 2009 May 15;324(5929):951-5. doi: 10.1126/science.1167975. Epub 2009 Apr 2.
Parent studyLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ann M Rasmusson, MD principal investigator

Boston University Chobanian & Avedisian School of Medicine, Dept of Psychiatry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician Assessed Sedation Levels for Each Participant (time frame: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468360, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.