RCT of Duloxetine & Pregabalin for the treatment of Gulf War Illness in Veterans

Olin Teague Veterans Center, Temple TX

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The proposed randomized controlled clinical trial is a resubmission to the CSR&D RFA on new treatments for Gulf War illnesses. In a randomized, double-blind, controlled trial, 180 Veterans who meet defining criteria for GWI and whose symptom profile includes chronic widespread pain and fatigue will be treated for 18 weeks with one of the following combinations; Group 1) AM Duloxetine + PM placebo; Group 2) AM placebo and PM Pregabalin; or Group 3) AM placebo + PM placebo. PRIMARY AIM 1: To evaluate the efficacy of a Duloxetine and Pregabalin for the treatment of pain and safety and tolerability of the medications in Veterans with GWI. It is anticipated that monotherapy with Duloxetine or Pregabalin will result in a greater number of GWI participants achieving a clinically relevant reduction in pain compared to PBO alone. SECONDARY AIM 2: To evaluate the efficacy of a Duloxetine and Pregabalin for the treatment of sleep, fatigue, and mood in Veterans with GWI. It is anticipated that the active treatments in Group 1 & 2 will result in numerically greater improvement in these symptoms compared to Group 3. EXPLORATORY GENETIC AIM: To obtain pilot data on genes associated with medication response and to begin development of potential classification schemes that could guide choice of therapy.