drugset / Trial / NCT01517711

Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)

NCT01517711

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This was 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 or PTSD resulting from a civilian trauma were recruited. Blinded tramadol ER was begun 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), were permitted thereafter. The primary hypothesis was that tramadol ER 100 to 300 mg every morning for 6 weeks would reduce the symptoms of PTSD relative to placebo. The primary outcome measures were 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.

Timeline

Start
2011-09
Primary completion
2014-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tramadol Other / unclassified 300 mg Oral