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.
At least one in four of the 700,000 U.S. Veterans who served in the 1990-1991 Gulf War suffer from Gulf War illness (GWI). Despite considerable research, effective treatments remain elusive. The symptom profile of GWI is similar to that of fibromyalgia syndrome (FMS), another chronic multi-symptom condition, but where progress has been made in identifying effective medications. The lack of progress in finding effective treatments for GWI, and the symptom similarities between GWI and FMS, provides a rationale for determining if Duloxetine and Pregabalin, two FDA approved FMS medications, can provide some relief to Veterans who suffer from GWI. As Central Texas is home to the highest number of Gulf War Veterans in the nation, our research team is ideally situated to conduct the randomized clinical trial proposed for this RFA. Our team will determine if Duloxetine and Pregabalin given as monotherapies or in combination can reduce some of the symptoms experienced in Veterans who suffer from GWI.