Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder

In brief

The purpose of this study is to test the differences between four active treatment conditions for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to examine predictors for PTSD and response to treatment in active duty military personnel, veterans, and civilians who served in Iraq and Afghanistan.

Key facts

Study ID

NCT01352637

Run by

Weill Medical College of Cornell University

People needed

192

Starts

2011-05-01

Expected to finish

2018-09-01

Last updated by the study team

2019-07-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of OEF-OIF (Operations Enduring Freedom or Iraqi Freedom) Combat Related PTSD;
• Female participants of childbearing potential must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide) during the course of the study, or to remain abstinent from sex, to ensure they do not become pregnant during the course of the study;
• Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments;
• Participants must be literate in English;
• Patients must be medically healthy and willing to take the study drug;
• VRE stimuli available must be consistent with subject's trauma.

You may not qualify if…

• Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder;
• Participation in a clinical trial during the previous 3 months;
• Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment;
• Patients who in the investigator's judgment pose a current suicidal or homicidal risk;
• Alcohol, medication, or illegal substance dependence within the past 90 days;
• Treatment with any other concomitant medication with primarily CNS activity, or treatment with any medication that the PI judges not acceptable for this study;
• history of seizures;
• Pregnancy or lactation.

Where it is running

• VA Long Beach Healthcare System — Long Beach, California, United States
• University of Southern California — Los Angeles, California, United States
• Emory University — Atlanta, Georgia, United States
• Walter Reed Army Medical Center/National Intrepid Center of Excellence (NICoE) — Bethesda, Maryland, United States
• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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