Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT04468360
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04468360
Study Brief:
Protocol Section:
NCT04468360