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Clinical Trials/NCT01211106
NCT01211106
Completed
Not Applicable

Integrated vs Sequential Treatment for PTSD and Addiction Among OEF/OIF Veterans

VA Office of Research and Development2 sites in 1 country183 target enrollmentFebruary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
VA Office of Research and Development
Enrollment
183
Locations
2
Primary Endpoint
PTSD Symptoms
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Detailed 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 Prolonged Exposure (PE) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

PTSD Symptoms

Time Frame: 16 weeks

PTSD checklist (PCL), the PCL version used with the civilian PCL. The PCL is a standardized self-report rating scale for PTSD comprising 17 items that correspond to the key symptoms of PTSD. Respondents indicate how much they have been bothered by a symptom over the past month using a 5-point (1-5) scale, circling their responses. Responses range from 1 Not at All - 5 Extremely thus the total score ranges from 17 - 85. Lower scores are associated with less severity/symptoms.

Drinking Outcome

Time Frame: 16 weeks

Percent days of heavy drinking during the sixteen weeks. The percentage of days in which heavy drinking occurred ranges from 0 - 100% with lower days associated with better outcomes.

Study Sites (2)

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