Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number
of U.S. military personnel and Veterans at risk of developing both substance use disorders
(SUDs) and Post Traumatic Stress Disorder (PTSD). If left untreated, individuals with SUDs
and/or PTSD are at risk for other mental health problems (e.g., depression), suicidal
ideation and attempts, physical health problems, reduced resiliency, lost productivity, and
family/relationship impairment. While mental health services are in place for U.S. military
personnel, substantial gaps in the treatment of co-occurring SUDs and PTSD exist and there
is little scientific evidence available to guide the provision of care. The proposed study
directly addresses this knowledge gap by testing the feasibility and preliminary efficacy of
an integrative behavioral intervention for the treatment of co-occurring SUDs and PTSD
modified for use among U.S. military personnel (including National Guard and Reservists) who
have served in Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). The
intervention, called "Concurrent Treatment with Prolonged exposure" or "COPE," represents a
novel treatment that integrates cognitive-behavioral therapy for SUDs with prolonged
exposure therapy for PTSD. In earlier studies with civilians, COPE has demonstrated efficacy
in reducing alcohol and drug use severity, PTSD symptoms, and associated mental health
problems (e.g., depression, anxiety). In this hybrid Stage Ib/Stage II study, we will (1)
use a manualized, well-tolerated behavioral treatment for SUDs and PTSD (COPE); (2) employ a
two-arm randomized between-groups experimental design (COPE versus a modified treatment-as
usual (TAU); and (3) examine standardized, repeated dependent measures of clinical outcomes
and process variables at 5 time points (pre-, mid-, and post-treatment; 3 and 6 month
follow-up). The proposed project is directly responsive to the mission of the National
Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism
(NIAAA) in that it seeks to enhance and accelerate research on the prevention and treatment
of alcohol and drug use disorders (including illicit and prescription drugs) and comorbid
conditions (e.g., PTSD, depression, sleep disturbances, HIV risk behaviors). The findings of
this study will provide empirical evidence to inform policies and programs to better serve
the needs of U.S. military personnel, Veterans, and their families.

Inclusion Criteria:

- Adult male and female active-duty OIF/OEF military personnel and separated OIF/OEF
veterans ages 18-65.

- Diagnosis of PTSD determined by a clinician-administered study interview.

Exclusion Criteria:

- Current bipolar disorder or other psychotic disorder (as determined by the evaluator
conducting the patient interview and medical record review)

- subjects with a current eating disorder or with dissociative identity disorder

- currently in ongoing therapy for SUDs or PTSD, who are not willing to discontinue
these therapies for the duration of the trial

- recently prescribed maintenance anxiolytic, antidepressant, or mood stabilizing
medications (must be stabilized for four weeks on meds before entry into study)

- Evidence of a moderate or severe traumatic brain injury (as determined by the
inability to comprehend the baseline screening questionnaires)