Project Summary/Abstract
Our goal is to improve opioid use disorder (OUD) treatment engagement and effectiveness for people who
inject drugs (PWID) with co-occurring posttraumatic stress disorder (PTSD). Medications for opioid use
disorder (MOUDs) such as methadone and buprenorphine are highly effective but underused. For PWID,
PTSD is exceedingly common (25-50%), intensifies illicit opioid use, doubles overdose likelihood, and
increases risk of HIV/HCV infection. Because PTSD is a modifiable risk factor for negative OUD outcomes,
reducing PTSD symptom severity can improve emotional regulation, and help PWID stay retained to lifesaving
MOUDs. In collaboration with three harm reduction organizations in New York State, we propose to adapt
Cognitive Processing Therapy (CPT), an evidence-based PTSD treatment, for the unique needs of PWID with
PTSD. Adapting CPT for the OUD population and SSP delivery will allow us to reach PWID who have high
rates of chronic PTSD, infrequently use conventional healthcare settings, and experience severe OUD-related
harms. Onsite PTSD Treatment to Improve MOUD Outcomes (OPTIMO) will be an innovative model of CPT,
whereby flexibly dosed CPT will be delivered via telehealth at SSPs and SSP staff navigators provide
additional in-person support. Our study team has a proven track record of collaborating with SSPs to provide
onsite low-barrier MOUDs, working with PWID who have PTSD, and successfully adapting CPT to low
resource, high adversity contexts, co-occurring substance use disorders, and telehealth delivery. In R61 Aim 1,
we will adapt CPT for PWID and delivery at SSPs. Guided by CDC’s framework for systematic intervention
adaptation and Consolidated Framework for Implementation Research, our modified CPT protocol will be
tailored through: 1) input from a stakeholder advisory board and 2) feedback from potential consumers and
SSP staff (6 focus groups; n = 4-6). Subsequently, in R61 Aim 2, we will preliminarily test and refine OPTIMO’s
acceptability and feasibility in the SSP setting by conducting a one-armed open trial (n = 15) and collecting
outcome and process measures from participants, teleproviders, and SSP navigators. Upon meeting R61
milestones of demonstrated feasibility and acceptability, we will conduct a hybrid Type 1 effectiveness-
implementation trial: we will enroll 252 SSP participants with co-occurring OUD and PTSD and randomize 1:1
to OPTIMO or wait-list control, comparing treatment effects on PTSD symptoms, MOUD retention, opioid use,
and injection-related risks (R33 Aim 1). To inform future scaling efforts, we will systematically evaluate
OPTIMO’s reach, adoption, implementation, and anticipated maintenance and their determinants through
interviews with participants, providers, and SSP leadership (R33 Aim 2). Completing these aims will lead to
more optimal integration of mental health care and MOUDs to better retain a high-risk population of PWID, thus
reducing the toll of untreated OUD.
