Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery

This study, called Project STRONGER, is looking at a new approach called "PCT+2HOPE" to help women with opioid use disorder (OUD) stay in their medication-assisted treatment (MOUD). This new approach combines two behavioral therapies, Present-Centered Therapy (PCT+) and Helping to Overcome PTSD through Empowerment (HOPE), which have been adapted for women who have also experienced intimate partner violence (IPV) and may have Post Traumatic Stress Disorder (PTSD). The study will compare PCT+2HOPE to standard care to see if it helps more women stay in MOUD treatment. You might be able to join if you are a woman, 18 or older, receiving MOUD treatment, have been on MOUD for more than 14 days, started your current treatment within the last year, and have experienced IPV. The study aims to enroll 532 women. The current status of the study is unclear.

Study design: This study is an interventional study comparing a new stepped care model to usual treatment. It plans to enroll 532 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The main goal of the study is measured at Week 26, which is about six months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Project STRONGER: Stepped Care for Opioid Use Disorder Treatment Engagement and Recovery

Recruiting

NAAges 18+InterventionalTreatment

Yale University

~532 participants

Updated 2026-07-16 on ClinicalTrials.gov

What's tested:PCT+2HOPE

At a glance

Recruiting sites

2 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Retention in MOUD treatment

Measured over Week 26

Conditions

Opioid Use Disorder

Intimate Partner Violence (IPV)

Post Traumatic Stress Disorder PTSD

Where it's being run

3 sites across 1 states

Connecticut3

Study leadership

Tami Sullivan, PhD · PRINCIPAL_INVESTIGATOR · Yale University
E. Jennifer Edelman, MD, MHS, AAHIVS · PRINCIPAL_INVESTIGATOR · Yale University
Dawn Johnson, PhD · PRINCIPAL_INVESTIGATOR · The University of Akron

Who to contact

Tami Sullivan, PhD

[email protected]

203-789-7645

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Retention in MOUD treatmentWeek 26
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).

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