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

Who is this study for? Patients with Posttraumatic Stress Disorder
What treatments are being studied? 3-day Differential Fear Conditioning, Extinction, and Extinction Retention Testing Paradigm
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston University School of Medicine
RECRUITING
Boston
Michigan
Wayne State University
ACTIVE_NOT_RECRUITING
Detroit
Contact Information
Primary
Ann M Rasmusson, MD
ptsdallo@bu.edu
617-358-1871
Backup
Kayla Brown
kdb123@bu.edu
Time Frame
Start Date: 2022-03-04
Estimated Completion Date: 2026-12
Participants
Target number of participants: 256
Treatments
Experimental: IV Allopregnanolone (Allo) for Extinction Retention (Expt. 1)
Arm 1 of Expt. 1 includes women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV Allo immediately after completion of extinction training.
Placebo_comparator: IV Placebo for Extinction Retention (Expt. 1)
Arm 2 of Expt. 1 includes women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV placebo immediately after completion of extinction training.
Experimental: IV Allo for Reconsolidation Blockade (Expt. 2)
Arm 1 of Expt. 2 will include women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV Allo immediately after reactivation of the conditioned fear memory by exposure to one conditioned stimulus (CS+).
Placebo_comparator: IV Placebo for Reconsolidation Blockade (Expt. 2)
Arm 2 of Expt. 2 will include will include women in the early follicular or mid-luteal phase of the menstrual cycle and men with PTSD who receive IV placebo immediately after reactivation of the conditioned fear memory by exposure to one conditioned stimulus (CS+).
Authors
Seth Norrholm
Related Therapeutic Areas
Sponsors
Leads: Boston University
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov