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

Last updated: April 10, 2026
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stimulant Use Disorder

Opioid Use Disorder

Post-traumatic Stress Disorders

Treatment

PCT+2HOPE

Clinical Study ID

NCT07115030
2000040103
R33DA059895
R61DA059895
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

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 resultof PTSD symptoms;

  • Available during the date/time of the intervention group

  • Able to read/understand English; and

  • Provide written informed consent.

Exclusion

Exclusion Criteria:

  • Fail a capacity-to-consent questionnaire;

  • Have an unstable medical condition (e.g., hospitalization, planned surgery, newlystarting chemotherapy, plans for palliative care) and/or unstable psychiatricillness (e.g., untreated psychosis) that would interfere with their ability toparticipate 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

Study Design

Total Participants: 532
Treatment Group(s): 1
Primary Treatment: PCT+2HOPE
Phase:
Study Start date:
April 01, 2026
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Liberation Programs

    Bridgeport, Connecticut 06610
    United States

    Active - Recruiting

  • Community Health Resources (CHR) Pathways Opiate Treatment Program

    Enfield, Connecticut 06082
    United States

    Site Not Available

  • The APT Foundation, Inc.

    West Haven, Connecticut 06516
    United States

    Site Not Available

  • Liberation Programs

    Bridgeport 5282804, Connecticut 4831725 06610
    United States

    Site Not Available

  • Community Health Resources (CHR) Pathways Opiate Treatment Program

    Enfield 4834040, Connecticut 4831725 06082
    United States

    Site Not Available

  • The APT Foundation, Inc.

    West Haven 4845419, Connecticut 4831725 06516
    United States

    Site Not Available

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