Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
Status:
Unknown status
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for
posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related PTSD
(n = more than 20) or PTSD resulting from a civilian trauma (n = fewer than 20) will be
recruited. Blinded tramadol ER will begin with a 100 mg daily dose for the first week, with
an option to increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of
100-300 mg tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The
primary hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce
the symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms
as rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions
scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms
will be stratified to ensure equivalence of the two arms (men and women, military and
civilian trauma).