Actively Recruiting
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
Led by Yale University · Updated on 2026-04-13
532
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman
- At least 18 years old
- Receiving medication for opioid use disorder (MOUD) treatment at a participating site
- Have been on MOUD for more than 14 days to allow for stabilization
- Started the current MOUD treatment episode within the past 12 months
- Experienced physical or psychological intimate partner violence (IPV) in their lifetime
- Have at least moderate impairment in psychosocial functioning due to PTSD symptoms
- Available during the scheduled intervention group sessions
- Able to read and understand English
- Provide written informed consent
You will not qualify if you...
- Unable to pass a capacity-to-consent questionnaire
- Have an unstable medical condition or unstable psychiatric illness that would interfere with study participation
- Will be unavailable for more than 4 consecutive weeks during the study (e.g., planned move or surgery)
- Unable to read or understand English
- Unable to provide at least one form of contact information
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Liberation Programs
Bridgeport, Connecticut, United States, 06610
Actively Recruiting
2
Community Health Resources (CHR) Pathways Opiate Treatment Program
Enfield, Connecticut, United States, 06082
Not Yet Recruiting
3
The APT Foundation, Inc.
West Haven, Connecticut, United States, 06516
Not Yet Recruiting
Research Team
T
Tami Sullivan, PhD
CONTACT
A
Ashley Clayton, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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