Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD (PACT)

This is an interventional treatment trial for PTSD focused on measuring Combat Trauma, Post traumatic stress disorder, PTSD, Sleep Disturbance, Trauma-Related Nightmares Read More

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.