RECRUITING

Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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 prevent them from triggering intensely distressing, disruptive, out-of-place responses. For example, during psychotherapy for PTSD, trauma memory activation engages two competing brain processes that affect recovery: "extinction" versus "reconsolidation" of trauma-related emotional, physiological, and behavioral responses. This study tests whether a single intravenous (IV) dose of allopregnanolone (Allo) compared to placebo (which is non-active): 1. promotes consolidation of extinction learning (sub-study 1) or 2. blocks reconsolidation physiological responses triggered by aversive memories (sub-study 2). The study also tests whether Allo compared to placebo affects retention of non-aversive memories.

Official Title

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

Quick Facts

Study Start:2022-03-04
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04468360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Chronic Posttraumatic Stress Disorder
  2. * Generally healthy and not on any prohibited medications (that could affect study outcomes)
  3. * 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
  4. * Females: must have a menstrual cycle and not be on hormonal birth control (with a few exceptions; see below)
  5. * If gender non-conforming: must not be on hormone therapy
  1. * Bipolar I disorder, schizophreniform disorder, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory hallucinations or negative beliefs
  2. * Moderate or severe substance use disorder within three months of screening
  3. * Sleep Apnea
  4. * History of a suicide attempt within 1 year of enrolling
  5. * Imminent risk to self or others or require clinical intervention to maintain safety
  6. * Unstable medical condition or condition that may affect outcomes
  7. * Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable; moderate TBI allowed for PK study)
  8. * 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.
  9. * Unable to tolerate IV placement or blood drawing by needle stick
  10. * Wear hearing aids or fail hearing test (not applicable to PK study)
  11. * 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

Contacts and Locations

Study Contact

Ann M Rasmusson, MD
CONTACT
617-358-1871
ptsdallo@bu.edu
Kayla Brown
CONTACT
kdb123@bu.edu

Principal Investigator

Ann M Rasmusson, MD
PRINCIPAL_INVESTIGATOR
Boston University School of Medicine, Dept of Psychiatry

Study Locations (Sites)

Boston University School of Medicine
Boston, Massachusetts, 02118
United States
Wayne State University
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Boston University

  • Ann M Rasmusson, MD, PRINCIPAL_INVESTIGATOR, Boston University School of Medicine, Dept of Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-04
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-03-04
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Extinction retention
  • Reconsolidation blockade
  • Fear conditioning paradigm
  • Conditioned threat stimulus (CS+)
  • Allopregnanolone (Allo)
  • Refractory PTSD
  • Trauma-focused therapy

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder