Clinical trial NCT01211106: Integrated vs Sequential Treatment for PTSD and Addiction
Official title: Integrated vs Sequential Treatment for PTSD and Addiction Among OEF/OIF Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Substance Addiction
Keywords: Treatment
PTSD
Addiction
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-09-29
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PTSD Symptoms
timeFrame: 16 weeks
measure: Drinking Outcome
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Philadelphia VA Medical Center, Philadelphia, PA
name: David W. Oslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott JC, Lynch KG, Cenkner DP, Kehle-Forbes SM, Polusny MA, Gur RC, Chen S, Foa EB, Oslin DW. Neurocognitive predictors of treatment outcomes in psychotherapy for comorbid PTSD and substance use disorders. J Consult Clin Psychol. 2021 Nov;89(11):937-946. doi: 10.1037/ccp0000693.
citation: Kehle-Forbes SM, Drapkin ML, Foa EB, Koffel E, Lynch KG, Polusny MA, Van Horn DH, Yusko DA, Charlesworth M, Blasco M, Oslin DW. Study design, interventions, and baseline characteristics for the Substance use and TRauma Intervention for VEterans (STRIVE) trial. Contemp Clin Trials. 2016 Sep;50:45-53. doi: 10.1016/j.cct.2016.07.017. Epub 2016 Jul 19.