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.