Mild traumatic brain injury (mTBI) caused by blast effects of explosive devices has been
called the "signature injury" of soldiers who served in the Iraq and Afghanistan conflicts.
mTBI can also occur from impact or hitting the head on an object or the ground. Although
termed "mild" in comparison to major brain injuries, people with mTBI can have problems with
their memory and concentration. People with mTBI can also find they are more irritable, have
more anxiety, and have trouble with their mood and sleep.
The purpose of this study is to see if a medication called prazosin can help treat chronic
headaches in people with mTBI. The Food and Drug Administration (FDA) has approved prazosin
for treating people with high blood pressure. At this time, the FDA has not approved prazosin
in the treatment of mTBI or headaches. Some people who have posttraumatic stress disorder
(PTSD) and have been taking prazosin for their medical conditions or who have taken it in
research studies have said they have fewer headaches.
Background and Rationale: Headaches following mild traumatic brain injury (mTBI) are common,
can be refractory to standard therapies, and may persist and worsen to become a debilitating
chronic pain syndrome. The purpose of this study is to evaluate the centrally acting alpha-1
adrenoreceptor (AR) antagonist drug prazosin as a prophylactic treatment for chronic
posttraumatic headaches (PTHAs). The impetus for this study comes from a large open-label
case series in Iraq and Afghanistan Veterans with mTBI and PTHAs and data from a
placebo-controlled trial evaluating use of prazosin for posttraumatic stress disorder (PTSD)
in active-duty Servicemembers (SMs). Findings from these studies showed that in addition to
decreasing PTSD-related symptoms and improving sleep quality, prazosin decreased the
frequency and severity of headaches, which were common in the study populations.
Study Objectives, Specific Aims, and Hypotheses: The objective of this study is to evaluate
the efficacy of prazosin as a prophylactic treatment for persistent PTHAs, which will be
accomplished by conducting a randomized placebo-controlled double blind trial of prazosin vs.
placebo in active-duty SMs and Veterans who were in military service at any time from October
7, 2001 to the present with persistent PTHAs.
Specific Aim 1: To determine the effect of prazosin compared to placebo on headache
frequency, headache severity and duration, use of abortive/analgesic medications, and
Specific Aim 2: To determine the effect of prazosin on sleep disturbance, PTSD symptoms,
depressive symptoms, alcohol consumption, global cognitive function, health-related
quality of life, and global clinical status.
Clinical Study Identifier
Seattle Institute for Biomedical and Clinical Research
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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