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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug, Other
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): promotes consolidation of extinction learning (sub-study 1) or blocks reconsolidation of 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: t
View:

• Between the ages of 18 and 55 (at time of enrollment), reproductively mature, and English speaking.

• Meet criteria for chronic PTSD (i.e., CAPS-5 determined PTSD duration more than 3 months).

• 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.

• For biological females:

‣ Natural menstrual cycle.

⁃ If of childbearing potential, female and partner must use 2 types of effective birth control (except for hormonal contraceptives, unless IUD or a device like Nuvaring) for a week before the IV Allo or placebo infusion, and for one month after.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Kristen Curran
kcurran0@mgh.harvard.edu
(617) 726-8508
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 96
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 aversive 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 aversive memory by exposure to one conditioned stimulus (CS+).
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov

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