Status:
RECRUITING
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 individu...
Detailed Description
Background: Allo is a neurosteroid (hormone) produced from progesterone by the brain, adrenal glands, testes, and ovaries. Production of Allo and its equally powerful, structurally similar, stereoisom...
Eligibility Criteria
Inclusion
- 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
- 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 require 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 (by self-report or toxicology testing) that may increase the risk of the side effects of IV Allo 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
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04468360
Start Date
March 4 2022
End Date
December 1 2026
Last Update
April 20 2025
Active Locations (2)
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1
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
2
Wayne State University
Detroit, Michigan, United States, 48202