A Randomized, Double-Blind, Placebo-Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in Post-Traumatic Stress
Abstract
Post-traumatic stress (PTS) is a condition that may develop after highly stressful life events, and it affects 8%-10% of adults in the U.S. civilian population and up to 30% of soldiers exposed to combat. Nightmares and other sleep disturbances, including difficulty falling or staying asleep, and unrestful sleep, are very common features of PTS in both civilian and military populations. These sleep disturbances create distress in and of themselves and research indicates that they may contribute to the development of PTS after stressful events and to the chronicity of PTS once it is present. Research indicates that a class of medications called alpha-1 blockers, including prazosin and now doxazosin, may improve nightmare symptoms and other nighttime symptoms of PTS. They may also improve daytime symptoms of the condition. Although there is substantial research suggesting prazosin may be effective in treating PTS symptoms, there is less research examining the potential benefits of doxazosin. Additionally, a large study recently completed by the Department of Veterans Affairs raises some questions about whether prazosin is broadly effective in Veterans and highlights the need for additional options to treat nightmares in PTS. Doxazosin has unique features that may give it advantages over prazosin for treating symptoms of PTS. For example, when doxazosin is taken at bedtime, it is most active in the body in the middle of the night -? when people need it the most for their nightmares. Furthermore, because its effects are long-lasting, it may also help patients with daytime symptoms of PTS. One small study and initial findings from research in our lab indicate that doxazosin is indeed effective for both PTS nightmares and non-nightmare (i.e., overall) PTS symptoms. More sophisticated research is now crucial for strengthening our confidence in these promising preliminary findings. The current proposal addresses the Fiscal Year 2016 Peer Reviewed Medical Research Program Topic Areas: Psychotropic Medications and Sleep Disorders. More specifically, this study addresses the Area of Encouragement: Research into the use and repurposing of psychotropic medications for the treatment of psychiatric disorders including post-traumatic stress, suicidal ideation, substance abuse, and other comorbidities. We propose a randomized, double-blind, placebo-controlled trial to examine the effects of doxazosin on nightmares, sleep quality, and overall (non-nightmare) symptoms in PTS. This design is the gold standard research approach for assessing the benefits of a treatment intervention. We will also measure participants? sleep using a lightweight wristband device that resembles a watch because we expect participants? experience of improved sleep to be reflected in improvements in objective measures of sleep quality. Additionally, we also expect doxazosin to produce benefits for other problems commonly seen in patients with PTS. For example, many individuals with PTS have problems with sexual functioning resulting from the disorder itself or from medications used to treat PTS symptoms. We will examine the effects of doxazosin on depression, sexual functioning, and overall quality of life. The proposed research study is expected to take 4 years. Participants will be adult men and women veterans with prominent nightmares and with moderate to severe non-nightmare symptoms of PTS. Participants will be eligible even if they have certain other medical problems or are taking other medications or treatments for PTS, since many individuals with PTS have other medical problems and are already in treatment for PTS. This will allow the researchers to determine how doxazosin works in typical treatment-seeking patients with PTS. We believe that this project is especially relevant to Service members, active duty Warfighters, and Veterans, among whom PTS is extremely common. However, this research will also be relevant to civilians.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Aug 07, 2017
- Source ID
- W81XWH1710234
Entities
People
- Anne Richards
Organizations
- Northern California Institute for Research and Education
- United States Army