Using Allopregnanolone to Improve PTSD Treatment
Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD
This study is testing if a single dose of a hormone called allopregnanolone can help adults with chronic PTSD by improving how they learn to manage their fear responses.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04468360 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a single intravenous dose of allopregnanolone (Allo) on individuals with chronic post-traumatic stress disorder (PTSD). It aims to determine whether Allo can enhance the consolidation of extinction learning or block the reconsolidation of trauma-related responses. The study employs a fear conditioning paradigm over three days, followed by extinction and retention testing. Participants will include adult men and women, with specific considerations for women's menstrual cycles due to hormonal fluctuations affecting Allo levels.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic PTSD who are generally healthy and not on medications that could interfere with the study.
Not a fit: Patients with severe psychiatric disorders, substance use disorders, or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatments for PTSD by improving memory processing related to traumatic experiences.
How similar studies have performed: While the use of allopregnanolone in PTSD treatment is a novel approach, preliminary research suggests potential benefits in related areas.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston University School of Medicine — Boston, Massachusetts, United States (Recruiting)
- Wayne State University — Detroit, Michigan, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Ann M Rasmusson, MD — Boston University School of Medicine, Dept of Psychiatry
- Study coordinator: Ann M Rasmusson, MD
- Email: ptsdallo@bu.edu
- Phone: 617-358-1871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.