Condition: Opioid Use Disorder · Intimate Partner Violence (IPV) · Post Traumatic Stress Disorder PTSD · Sponsor: Yale University
Using a hybrid type 1 effectiveness-implementation approach, this study aims to evaluate the impact of a novel stepped care model ("PCT+2HOPE") versus treatment as usual (TAU) on increasing retention in community-based medication for opioid use disorder (MOUD) treatment among women who have experienced intimate partner violence (W-IPV). PCT+2HOPE includes Present-Centered Therapy (PCT+) with stepped care as indicated by moderate, severe, or extreme PTSD-related impairment in psychosocial functioning to Helping to Overcome PTSD through Empowerment (HOPE), two evidence-based behavioral interventions adapted for women with opioid use disorder (OUD). We will examine the effectiveness of PCT+2HOPE vs. TAU on the primary outcome (i.e., retention in MOUD treatment) and secondary outcomes related to trauma (i.e., PTSD-related impairment in psychosocial functioning and depression), substance use (i.e. OUD symptom severity, extra-medical opioid use \[i.e., use of prescription opioids without a doctor's prescription; in greater amounts, more often, longer than prescribed, or for a reason other than a doctor said they should be used\], and recovery), and empowerment. We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an implementation-focused process evaluation.
This description comes directly from the study's public registry record.
Tami Sullivan, PhD · 203-789-7645 · tami.sullivan@yale.edu
Ashley Clayton, MA · 203-789-7645 ext 121 · ashley.clayton@yale.edu
Always discuss trial participation with your own doctor first.
| Liberation Programs | Bridgeport, Connecticut, United States | Recruiting |
| Community Health Resources (CHR) Pathways Opiate Treatment Program | Enfield, Connecticut, United States | Not Yet Recruiting |
| The APT Foundation, Inc. | West Haven, Connecticut, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07115030