Clinical trial NCT00532493 (phase 3, status: completed)
Conditions: ptsd, sleep disorders
ICD codes: G47.9, G47.21, G47.22, G47.23, G47.52, G47.29, G47.20
Drugs: prazosin
SMILES: COC1=C(OC)C=C2C(N)=NC(=NC2=C1)N1CCN(CC1)C(=O)C1=CC=CO1
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.