This study plans to learn more about whether taking the medication, Prazosin, in the
weeks immediately following a traumatic event can help to reduce the risk of developing
posttraumatic stress disorder (PTSD).
Specific Aim 1: Test the efficacy of the drug prazosin in decreasing PTSD symptom
severity as compared to placebo at 3 months post rape as measured by the
Clinician-Administered PTSD Scale version 5 (CAPS-5, primary outcome) as well as
associated secondary outcomes (PTSD diagnosis rate, sleep scores, and depression
symptoms) at 3 months.
Hypotheses:
1a: Severity score on the CAPS-5 will be significantly lower in rape victims randomized
to receive prazosin within 24 hours of at the University of Colorado Hospital (UCH)
Emergency Department and continue on a titrated dose for one month compared to the
control group at 3 months post rape. Secondarily, PTSD diagnosis rate will be lower in
the prazosin group versus the control group at 3 months.
1b: Participants randomized to receive prazosin will have better sleep scores as measured
by the Pittsburgh Sleep Quality Index (PSQI) and PSQI Trauma addendum at 3 months post
rape as compared to the control group.
1c: Severity scores for major depressive symptoms as measured by the Patient Health
Questionnaire (PHQ-9) will be significantly lower in rape victims randomized to receive
prazosin as compared to the control group at 3 months post rape.
1d: Sleep scores as measured by the PSQI and PSQI Trauma addendum will be positively
correlated with PTSD symptom severity as measured by the CAPS-5 such that higher (worse)
sleep scores are associated with more PTSD symptoms.
Rationale: Many studies have shown that sleep disturbances and nightmares that occur
directly after a traumatic event are a good predictor of the development of PTSD.
Prazosin has been shown to improve PTSD-related sleep disturbance, including nightmares.
If prazosin can effectively treat sleep disturbance in the weeks immediately following a
traumatic experience and decrease the rate of PTSD and the severity of symptoms, then it
could possibly become the standard of care for individuals exposed to a traumatizing
event.
Brief overview of methods: Females between the ages of 18 and 50 years will be recruited
directly from the ED at University of Colorado Hospital with the assistance of the
Forensic Nurse Examiners. Those who elect to take part in this study and complete the
informed consent process will be randomized to receive either prazosin or placebo. This
is a double-blind study, so neither the participant nor the study doctor/team will know
whether a participant is in the treatment (prazosin) or control (placebo) group.
Participants will receive three 2mg tabs and three 1mg tbs for titration purposes
(prazosin or placebo equivalent) before they leave the hospital, with instructions to
take the first dose (2 mg) 1 hour before bed, the first night after being seen in the ED.
Study staff will follow up the next day to inquire about the participant's general
condition, possible side-effects, sleep, and to schedule the first study visit (at 72
hours after treatment in ED). PTSD and posttraumatic stress symptoms, symptoms of
depression, suicidality, medication compliance, side-effects and adverse events will be
monitored and assessed by study personnel at weekly study visits for the duration of the
med trial (6 weeks; 3 weeks on medication and 2-3 weeks of tapering off of medication)
and again at 3-months post. However, participants will be instructed to report any
changes or concerns as needed. Each participant will also complete a daily sleep log for
the duration of their participation in the study.
