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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00356278 |
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.
Condition | Intervention | Phase |
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Stress Disorder, Post Traumatic |
Drug: D-Cycloserine Drug: Alprazolam Behavioral: Virtual Reality Exposure Therapy Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD |
Estimated Enrollment: | 150 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Participants will receive VRE therapy and D-cycloserine
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Drug: D-Cycloserine
D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Behavioral: Virtual Reality Exposure Therapy
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.
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B: Active Comparator
Participants will receive VRE therapy and alprazolam
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Drug: Alprazolam
Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Behavioral: Virtual Reality Exposure Therapy
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.
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C: Placebo Comparator
Participants will receive VRE therapy and placebo
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Behavioral: Virtual Reality Exposure Therapy
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.
Drug: Placebo
Placebo will be administered in the same manner as the active drugs.
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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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Feea Leifker, MPH | 404-712-8300 | fleifke@emory.edu |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30329 | |
Contact: Feea Leifker, MPH 404-712-8300 fleifke@emory.edu | |
Principal Investigator: Barbara O. Rothbaum, PhD, ABPP | |
Atlanta Veterans Affairs Medical Center | Recruiting |
Atlanta, Georgia, United States, 30033 | |
Sub-Investigator: Rebekah Bradley, PhD |
Principal Investigator: | Barbara O. Rothbaum, PhD, ABPP | Emory University |
Responsible Party: | Emory University ( Barbara O. Rothbaum, PhD, ABPP ) |
Study ID Numbers: | R01 MH070880, DATR AD-TS |
Study First Received: | July 24, 2006 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00356278 |
Health Authority: | United States: Federal Government |
D-Cycloserine Virtual Reality Exposure Therapy |
Veterans Cognitive Behavior Therapy Translational Research |
Cycloserine Alprazolam Anxiety Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Antimetabolites Anti-Infective Agents Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Anti-Infective Agents, Urinary |
Renal Agents Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Antitubercular Agents Central Nervous System Agents |