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NCT07115030 · ClinicalTrials.gov registry record · NA
Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
A NA study, sponsored by Yale University.
- Recruiting
- Registry status
- NA
- Development phase
- 532
- Enrollment target
NCT07115030 is a NA study that is actively recruiting participants, run by Yale University. The registered enrollment target is 532 participants.
The verdict
NCT07115030, a NA study, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- NA
- Development phase
- 532 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL PCT+2HOPE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2029-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07115030
The ClinicalTrials.gov registry entry for NCT07115030 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 532 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PCT+2HOPE is the first listed.
NCT07115030 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07115030 about?
NCT07115030 is a clinical study titled "Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery". 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 experien...
What is the current status of trial NCT07115030?
This trial is currently recruiting. It is a NA study. The enrollment target is 532 participants. The study started on 2026-06-01. Estimated completion is 2029-08-31.
What interventions are being tested in trial NCT07115030?
The interventions under investigation include: PCT+2HOPE (BEHAVIORAL).
Who is sponsoring clinical trial NCT07115030?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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