D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD

NCT ID: NCT00356278

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2014-06-30

Brief 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.

Conditions

Stress Disorder, Post Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Participants will receive VRE therapy and D-cycloserine

Group Type: EXPERIMENTAL

D-Cycloserine

Intervention Type: DRUG

D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

Virtual Reality Exposure Therapy

Intervention Type: BEHAVIORAL

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.

B

Participants will receive VRE therapy and alprazolam

Group Type: ACTIVE_COMPARATOR

Alprazolam

Intervention Type: DRUG

Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

Virtual Reality Exposure Therapy

Intervention Type: BEHAVIORAL

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.

C

Participants will receive VRE therapy and placebo

Group Type: PLACEBO_COMPARATOR

Virtual Reality Exposure Therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: DRUG

Placebo will be administered in the same manner as the active drugs.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Placebo

Placebo will be administered in the same manner as the active drugs.

Intervention Type: DRUG

Other Intervention Names

Xanax

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Barbara O. Rothbaum, PhD

Professor in Psychiatry and Associate Vice Chair of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara O. Rothbaum, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

References

Rauch SAM, Koola C, Post L, Yasinski C, Norrholm SD, Black K, Rothbaum BO. In session extinction and outcome in Virtual Reality Exposure Therapy for PTSD. Behav Res Ther. 2018 Oct;109:1-9. doi: 10.1016/j.brat.2018.07.003. Epub 2018 Jul 20.

Reference Type: DERIVED

PMID: 30059794 (View on PubMed)

Norrholm SD, Jovanovic T, Gerardi M, Breazeale KG, Price M, Davis M, Duncan E, Ressler KJ, Bradley B, Rizzo A, Tuerk PW, Rothbaum BO. Baseline psychophysiological and cortisol reactivity as a predictor of PTSD treatment outcome in virtual reality exposure therapy. Behav Res Ther. 2016 Jul;82:28-37. doi: 10.1016/j.brat.2016.05.002. Epub 2016 May 7.

Reference Type: DERIVED

PMID: 27183343 (View on PubMed)

Rothbaum BO, Price M, Jovanovic T, Norrholm SD, Gerardi M, Dunlop B, Davis M, Bradley B, Duncan EJ, Rizzo A, Ressler KJ. A randomized, double-blind evaluation of D-cycloserine or alprazolam combined with virtual reality exposure therapy for posttraumatic stress disorder in Iraq and Afghanistan War veterans. Am J Psychiatry. 2014 Jun;171(6):640-8. doi: 10.1176/appi.ajp.2014.13121625.

Reference Type: DERIVED

PMID: 24743802 (View on PubMed)

Other Identifiers

DATR AD-TS

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH070880

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00024846

Identifier Type: -

Identifier Source: org_study_id