This trial is active, not recruiting.

Conditions ptsd, substance addiction
Treatments prolonged exposure, motivational enhancement therapy
Sponsor VA Office of Research and Development
Start date February 2011
End date March 2016
Trial size 200 participants
Trial identifier NCT01211106, ZDA1-03-W10


The investigators are examining different treatment strategies of helping patients with PTSD and addiction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment
prolonged exposure
Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.
motivational enhancement therapy
Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.

Primary Outcomes

substance use and PTSD symptoms
time frame: 16 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Male or female Persian Gulf Era veterans between 18-65 years old. Older individuals are unlikely to have served in Iraq or Afghanistan. - Current diagnosis of PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms, as indicated by a score of at least 50 on the PCL - Current abuse or dependence on alcohol, stimulants such as cocaine, opioids, including prescription opioids or benzodiazepines. Subjects must report using on average at least 10 out of 30 days prior to signing consent. Of note: subjects can be abusing or dependent upon nicotine or marijuana but these will not be considered sufficient for inclusion - Provides informed consent - Speaks and reads English Exclusion Criteria: - Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment - Meets current DSM-IV criteria for bipolar affective disorder, schizophrenia or any psychotic disorder - Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease - History of moderate or severe traumatic brain injury (TBI) - Participation in Prolonged Exposure Therapy in the last 6 months. - Initiation of a new psychotherapy program in the last 2 months. - Active participation in a formal addiction treatment program. Actively engaged is defined as any visit in the program in the prior month and pending future appointments for the treatment of addictions - Change in psychotropic medication in the 1 month prior to treatment except for the use of oxazepam for alcohol detoxification or a taper of a previously used benzodiazepine. - Therapeutic use of a benzodiazepine greater than the equivalent of more than 40 mg of diazepam (see chart) at the time of randomization.

Additional Information

Official title Integrated vs Sequential Treatment for PTSD and Addiction Among OEF/OIF Veterans
Principal investigator David W. Oslin, MD
Description The investigators hypothesize that Veterans in the integrated conditions will show greater reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and 9 month follow-ups. The investigators further hypothesize that offering Veterans PE at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.