NCT07115030 Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery
| NCT ID | NCT07115030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 532 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 532 participants in total. It began in 2026-06-01 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Woman; * Are ≥ 18 years old; * Receive MOUD treatment at one of the participating sites; * Have received MOUD for \>14 days to allow for initial stabilization; * Have initiated the current treatment episode within the past 12 months; * Experienced physical or psychological IPV in their lifetime; * Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms; * Available during the date/time of the intervention group * Able to read/understand English; and * Provide written informed consent. Exclusion Criteria: * Fail a capacity-to-consent questionnaire; * Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities; * Will be unavailable for \>4 consecutive weeks during the study period (e.g., anticipated move, planned surgery); * Are unable to read/understand English; * Inability to provide at least one form of contact
Contact & Investigator
Tami Sullivan, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07115030 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07115030 currently recruiting?
Yes, NCT07115030 is actively recruiting participants. Contact the research team at tami.sullivan@yale.edu for enrollment information.
Where is the NCT07115030 trial being conducted?
This trial is being conducted at Bridgeport, United States, Enfield, United States, West Haven, United States.
Who is sponsoring the NCT07115030 clinical trial?
NCT07115030 is sponsored by Yale University. The principal investigator is Tami Sullivan, PhD at Yale University. The trial plans to enroll 532 participants.