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New treatment option for Post Traumatic Stress Disorder
Official title Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD.
ClinicalTrials.gov ID: NCT07079761
What this study is testing
What is Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer.?
Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California, Davis, GMP manufacturer. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post traumatic stress disorder.
Also referred to as U.S. P. equivalent: brexanolone (SAGE Therapeutics) (IV Allopregnanolone with Captisol).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- For biological females:
You likely can't join if
- Present an imminent risk to self or others or require clinical intervention to maintain safety
- Diagnosis of moderate or severe substance use disorder within three months of screening per administration of the DIAMOND substance abuse evaluation...
- Bipolar I disorder, schizophreniform disorders, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory...
- History of a suicide attempt within 1 year of enrolling.
- A history of severe TBI is exclusionary for the PK-1 and PK-2 studies. A history of moderate or severe TBI is exclusionary for the main studies...
- Diagnosis of sleep apnea
See the full eligibility criteria
- 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...
- Present an imminent risk to self or others or require clinical intervention to maintain safety
- Diagnosis of moderate or severe substance use disorder within three months of screening per administration of the DIAMOND substance abuse evaluation. Diagnosis of a mild substance use disorder within three months of...
- Bipolar I disorder, schizophreniform disorders, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory hallucinations or negative beliefs.
- History of a suicide attempt within 1 year of enrolling.
- A history of severe TBI is exclusionary for the PK-1 and PK-2 studies. A history of moderate or severe TBI is exclusionary for the main studies (i.e., Expt. 1 and Expt. 2).
- Diagnosis of sleep apnea
- Awake resting O2 saturation \< 96%
- Severe renal failure with an eGFR \<30 ml/min
- Use of medications or substances (by report or toxicology testing) will be exclusionary under the following conditions:
- During screening for eligibility:
- Use of illicit substances, as well as prescribed opiates or benzodiazepines (either reported or detected on urine toxicology testing) will be exclusionary.
- Reported non-dependent use of cannabinoids or nicotine (indicated by a positive urine toxicology or cotinine test at screening) will not be exclusionary if the individual agrees to abstain from cannabinoids and nicotine...
- A positive urine alcohol test at medical screening (which indicates uncontrolled alcohol use and likely moderate to severe alcohol dependence) will be exclusionary.
- A high serum gamma-glutamyl-transferase (GGT) test at screening (indicative of more remote recent drinking but not necessarily moderate to severe alcohol use or dependence) will not be exclusionary if the individual...
- Use of non-illicit over the counter or prescribed medications that may increase the risk of IV Allo side effects or adversely affect the experimental results is exclusionary. Participants may agree to stop...
- On the mornings of the PK-1, PK-2, Expt. 1 or Expt. 2 experimental procedures:
- Use of any medications or substances that may increase the risk of IV Allo side effects or adversely affect the experimental results (indicated by report, urine toxicology, urine nicotine/cotinine testing, or urine...
- Systemic hormone therapy or contraception will be exclusionary [Exception: Hormonal IUDs (e.g., Mirena, Kyleena, Liletta, and Skyla) or other contraceptive devices (e.g., Nuvaring)] will be allowed if the participant...
- Pregnancy (urine pregnancy tests given at each in-person session).
- Breast-feeding.
- Unable to tolerate IV placement or blood drawing by needle stick.
- Wear hearing aid(s) (For Expt. 1 and 2, not PK studies).
- Fail hearing test (For Expt. 1 and 2, not PK studies).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.