D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
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Purpose
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 |
|---|---|---|
|
Stress Disorder, Post Traumatic |
Drug: D-Cycloserine Drug: Alprazolam Behavioral: Virtual Reality Exposure Therapy Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD |
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
- Psychophysiological measures [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
- PTSD Symptom Scale Self-Report [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6 and 12 follow-ups ] [ Designated as safety issue: No ]
- Clinical Global Impressions Scale [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
- Quality of Life Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
- State-Trait Anxiety Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
- Beck Depression Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Participants will receive VRE therapy and D-cycloserine
|
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.
|
|
Active Comparator: B
Participants will receive VRE therapy and alprazolam
|
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.
Other Name: Xanax
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.
|
|
Placebo Comparator: C
Participants will receive VRE therapy and placebo
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets DSM-IV criteria for PTSD due to Iraq military trauma
- Speaks English
- Healthy overall
Exclusion Criteria:
- History of mania, schizophrenia, or other psychoses
- Suicidal
- Current alcohol or drug dependence
- Medication free within 2 weeks of study entry for any medication that has been taken less than daily for the past month and medicine free within 4 weeks of study entry for any anxiolytic medication that has been taken daily for the last month or more
- Pregnant
- Special medical conditions, such as kidney insufficiency, chronic diseases, or history of significant head injury
- Stabilized on potentially data obscuring medication such as glucocorticoids
Contacts and Locations| Contact: Mark Burton | 404-727-3662 | msburto@emory.edu |
| Contact: Michelle Hammond-Susten, MSW | 404-727-8964 | mhammo3@emory.edu |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: Mark Burton 404-727-3662 msburto@emory.edu | |
| Contact: Michelle Hammond-Susten, MSW 404-727-8964 mhammo3@emory.edu | |
| Principal Investigator: Barbara O. Rothbaum, PhD, ABPP | |
| Principal Investigator: | Barbara O. Rothbaum, PhD, ABPP | Emory University |
More Information
No publications provided
| Responsible Party: | Barbara O. Rothbaum, PhD, Professor in Psychiatry and Associate Vice Chair of Clinical Research, Emory University |
| ClinicalTrials.gov Identifier: | NCT00356278 History of Changes |
| Other Study ID Numbers: | R01 MH070880, DATR AD-TS |
| Study First Received: | July 24, 2006 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Emory University:
|
D-Cycloserine Virtual Reality Exposure Therapy |
Veterans Cognitive Behavior Therapy Translational Research |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Alprazolam Cycloserine Nootropic Agents Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents |
Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites |
ClinicalTrials.gov processed this record on May 19, 2013