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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: Recruiting NA study, sponsored by Yale University.
NCT07115030 is a NA study that is actively recruiting participants, run by Yale University. The registered enrollment target is 532 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Retention in MOUD treatment at week 26. This will be measured through a combination of self-report with objective confirmation (e.g., via electronic health record, provider-confirmed treatment engagement/retention, medication bottles, urine toxicology testing).
Interventions
- BEHAVIORAL PCT+2HOPE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 532 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2029-08-31 |
| Phase | NA |
What NCT07115030 shows while recruiting
NCT07115030 is an interventional study that assigns participants to a tested intervention. The registered 532 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which PCT+2HOPE is the first listed.
NCT07115030 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07115030's enrollment target sits among peer trials
532 188th of 2000 higher than 1,813 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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