D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
Condition: Stress Disorder, Post Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine whether a combination of virtual reality exposure therapy and
      D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.
    

Detailed description: 
      Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have
      witnessed or experienced a traumatic event. Veterans of war are at an increased risk for
      developing PTSD because of their experiences with war and combat. Symptoms of PTSD often
      include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally
      numb or distant toward others. Fortunately, PTSD can be treated, usually with some
      combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality
      exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about
      trauma by facing situations with the use of virtual reality. D-cycloserine is a medication
      that has been found to enhance the effects of psychotherapy in recent studies. This study
      will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms
      in Iraq war veterans.

      During this study, all participants will undergo one educational session and five VRE
      sessions. The first session will involve gathering information, learning common reactions to
      trauma, and participating in a breathing relaxation approach. The following five sessions
      will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant
      will wear a head-mounted display during which they will view scenario settings such as
      cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned
      to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before
      each VRE session.

      Prior to the first treatment session, participants will undergo a startle reaction procedure.
      This will entail hearing sudden tones that last a fraction of a second, and viewing virtual
      reality scenes. Three small electrodes, attached to each participant's face, will measure the
      number of eye blinks during the procedure. At several times throughout the study, heart rate
      and skin conductance will also be measured with electrodes. Collection of saliva samples and
      measurement of blood pressure will also occur several times during this study. Before,
      during, and immediately after treatment, participants will complete questionnaires.
      Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to
      schedule a time for an interview, additional questionnaires, and the virtual reality-based
      assessment.
    

Intervention name(s): D-Cycloserine; Alprazolam; Virtual Reality Exposure Therapy; Placebo
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.; Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.; VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.; Placebo will be administered in the same manner as the active drugs.
Other intervention name(s): Xanax
Intervention MeSH terms: Cycloserine; Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: D-Cycloserine; Virtual Reality; Exposure Therapy; Veterans; Cognitive Behavior Therapy; Translational Research