Optimal Treatment of Veterans with PTSD and Comorbid Opiate Use Disorder (OUD)
Project Number1I01CX001517-01A2
Contact PI/Project LeaderPETRAKIS, ISMENE L.
Awardee OrganizationVA CONNECTICUT HEALTHCARE SYSTEM
Description
Abstract Text
Post-traumatic stress disorder (PTSD) is a serious disorder among Veterans and affects up to 20 % of
Veterans from the recent conflicts. Given the high incidence of PTSD among Veterans, the US Department of
Veterans Affairs (VA) and Department of Defense (DoD) have made the treatment of PTSD a priority. Cognitive
Processing Therapy (CPT, CPT-C) is one of the standard evidence based therapies for PTSD and was rolled out
nationally in a large dissemination project by the VA and the DoD as one of the gold standard treatments for
PTSD. Recently the VA DoD Clinical Practice Guidelines on the Management of PTSD and Acute Stress
Reaction (2017) have stated that individual trauma focused therapies should be the first line of treatment.
Despite the effort in rolling out evidence based therapy, there is a lack of knowledge of the efficacy of
these interventions in veterans with comorbid disorders.
There is considerable evidence showing that PTSD is often comorbid with other substance use disorders
including opioid dependence. Opioid use disorder (OUD) is a well-documented epidemic among the general
population, and also has had a significant effect on Veterans. While the etiology is unknown, it is possible that
the incidence may be in part due to the overuse of highly addictive prescription opioids leading to iatrogenic
opioid dependence and the development of addictive disorders. Recent evidence has clearly shown that
prescription OUD can lead to dependence on street drugs such as heroin.
Buprenorphine treatment is the established treatment for those with opiate use disorders; it is the
recommended treatment for Veterans with OUD and its use is leading to larger number of Veterans maintained
on buprenorphine. However, the efficacy of treatments for PTSD among those maintained on buprenorphine is
unknown.
The objective of this study is to test a standard psychotherapy for PTSD in Veterans who also suffer
from OUD. Specifically, this study will test whether Cognitive Processing Therapy (CPT)-C is more effective
in treating PTSD, compared to a control group (Individual Drug Counseling or IDC; which approximates
treatment as usual), among Veterans with PTSD and comorbid OUD who are maintained on buprenorphine.
Other objectives include effect on opiate use, treatment retention, side effects, pain tolerance and general
functioning.
This will be a randomized, open-label clinical trial. The study has three phases. In Phase one, the
induction phase, all Veterans (n=160) will be started on 2 mg of buprenorphine. The dose of buprenorphine
will be increased over 5-7 days; dose will be clinically determined. After the maintenance dose of
buprenorphine is reached all Veterans will enter Phase two, the treatment phase. During this phase Veterans
will be randomly assigned to CPT-C or standard IDC for 12 weeks. They will be seen weekly for psychotherapy
and also regularly (weekly, then biweekly, then monthly) for buprenorphine management, symptom
evaluation, and medication refill. After completing treatment Veterans will be referred to a buprenorphine
clinic for ongoing care and will enter the Third phase of the study, the follow up. During this phase they will be
seen 1 month and 3 months after the completion of treatment.
Public Health Relevance Statement
Post-traumatic stress disorder (PTSD) is a serious disorder and Veterans with PTSD often suffer from other
disorders, such as opioid use disorder. Standard treatment for PTSD includes psychotherapy, such as Cognitive
Processing Therapy (CPT-C). Standard treatment for those with opiate dependence is buprenorphine.
However, there are still significant gaps in knowledge when considering treatment options: we do not know
how effective these interventions are when Veterans have comorbid disorders – PTSD and opioid use disorder.
This study will test a standard treatment (psychotherapy with CPT-C) against a control group in Veterans
who are treated with buprenorphine and diagnosed with PTSD and comorbid opioid use disorder. The study
will test how effective this treatment is on PTSD symptoms, drug use, and functioning.
NIH Spending Category
No NIH Spending Category available.
Project Terms
AbstinenceAddressAdverse effectsAffectAwarenessBackBehavior TherapyBuprenorphineCaringClinicClinicalClinical Practice GuidelineClinical TrialsCognitiveCognitive TherapyComorbidityConflict (Psychology)Control GroupsCounselingDSM-VDepartment of DefenseDependenceDevelopmentDiagnosisDiseaseDoseDrug usageEpidemicEtiologyEvaluationEvidence based treatmentGeneral PopulationGoldHealth ProfessionalHealth SurveysHeroinIatrogenesisIncidenceIndividualInternetKnowledgeLeadMaintenanceManualsMeasuresMental HealthMental disordersMilitary PersonnelNumeric Rating ScaleOpiate AddictionOpioidOpioid agonistOpioid replacement therapyPain ThresholdPain intensityPain managementPatternPerformancePharmaceutical PreparationsPhasePhysiciansPost-Traumatic Stress DisordersPractice GuidelinesPredispositionPsychotherapyPublic HealthRandomizedRandomized Controlled TrialsReadinessReportingSeveritiesSleepSleep disturbancesSleeplessnessStreet DrugsSubstance Use DisorderSymptomsTestingTimeLineToxicologyTraumaTreatment EffectivenessTreatment EfficacyUnited StatesUnited States Department of Veterans AffairsUrineVeteransWorkacute traumatic stress disorderaddictionadverse outcomebasebuprenorphine treatmentchronic paineffective interventioneffective therapyevidence baseexperiencefollow-upfunctional disabilityheroin overdoseheroin usehigh risk behaviorindexingopen labelopioid epidemicopioid useopioid use disorderoptimal treatmentsoverdose deathprescription opioidprogram disseminationpsychoeducationpsychosocialstandard carestandard of caresymptom managementsymptom treatmenttreatment as usualtreatment group
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