Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery (NCT07115030)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Liberation Programs — Bridgeport, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
- PCT+2HOPE (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Liberation Programs — Bridgeport, Connecticut
- Community Health Resources (CHR) Pathways Opiate Treatment Program — Enfield, Connecticut
- The APT Foundation, Inc. — West Haven, Connecticut
📞 Contact the Study Coordinator
Phone: (203) 789-7645
Email: tami.sullivan@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Opioid Use Disorder
- Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder — Atlantic City, New Jersey
- The Emergency Department Longitudinal Integrated Care — Seattle, Washington
- Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT — La Jolla, California
- Extended-release Buprenorphine as a Novel Low-dose Induction Strategy — Boston, Massachusetts
- Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial — Ann Arbor, Michigan
- Telemedicine XR-B for Individuals in Jail — Cumberland, Maryland
Explore by condition: All Opioid Use Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.