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 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT00532493
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years.
* Exposure to one or more life-threatening war zone trauma events per the Combat
* Exposure Scale \[78\] and documented by Department of Defense (DD) Form 214, Combat Action Ribbon (Marines), Combat Infantry Badge (Army), or other clear evidence of war zone trauma exposure.
* Eligible for VA health care.
* Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of PTSD derived from the CAPS.
* CAPS total score \>50.
* CAPS Recurrent Distressing Dreams item score \>5 (of maximum score of 8).
* Capable of giving informed consent.
* Stable dose of non-exclusionary (see below) medications for at least 4 weeks prior to randomization.
* Psychotherapeutic treatment stable for at least 4 weeks prior to randomization.
* Good general medical health (see Medical Exclusion Criteria below).
* Female participants must agree to use a reliable form of birth control during the study.
Exclusion Criteria:
Medical:
* Acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension (systolic \<110) or orthostatic hypotension (systolic drop \> 20 millimeters of mercury after two minutes standing or any drop accompanied by dizziness); chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy.
* Untreated sleep apnea, diagnosed by a sleep study, is exclusionary. Treated sleep apnea (e.g., Continuous Positive Airway Pressure, surgery) will not be exclusionary.
* Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.
* Wounds requiring surgery, embedded shrapnel, and recent surgical amputation do not comprise an exclusion if the individual is otherwise medically eligible.
* Women of childbearing potential with positive pregnancy test or refusal to use effective birth control method, or who are breastfeeding will be excluded.
Psychiatric/Behavioral:
* Meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified (NOS), delirium, or any DSM-IV cognitive disorder.
* Exclusion for psychotic disorder is not to be confused with combat trauma-induced reexperiencing symptoms (transient dissociative states or flashbacks), which will not be exclusionary.
* Substance dependence disorder within 3 months or any current substance dependence (stable methadone maintenance will not be exclusionary).
* Current cocaine or stimulant abuse.
* Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.
* Nonsuicidal depression comorbid with PTSD will not be exclusionary (see below).
Medications/Therapies:
* Current use of prazosin or other alpha-1 antagonist.
* Previous adequate trial of prazosin for PTSD.
* Subjects on trazodone will undergo a 2-week washout period before baseline assessment. (Combining prazosin and trazodone may increase risk of priapism).
* Sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) will be not be permitted during the study dose titration period because of increased risk of hypotension in combination with alpha-1 blockers. Following achieving stable dose of study drug, sildenafil, tadalafil, and vardenafil will be permitted at 1/2 the usual starting dose.
* Stimulants or alternative medications with stimulant properties (e.g., ephedra).
* Recent exposure therapy and/or Eye Movement Desensitization and Reprogramming (EMDR). These therapies must have been completed \> 4 weeks before randomization.
* Other psychotropic medications and/or maintenance psychotherapy at a stable dose for at least 4 weeks will not be exclusionary.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00532493
Study Brief:
Protocol Section:
NCT00532493