Supporting Treatment for Opioids and Recovery Capital (STORC) - R61 Phase

NCT07787039 | Not Yet Recruiting DMC

• 1 other identifier: R61DA064704
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

We are studying whether training an identified support person and providing patient navigation (i.e. a peer recovery specialist assisting you with finding the right support) after delivery can increase "recovery capital"-the resources that help people with opioid use disorder (OUD) stay in treatment and recover. This study will build upon the research team's prior work in conducting research among pregnant and parenting women with OUD. This project will be directed by the research team at Friends Research Institute in close collaboration with their research and clinical partners at the University of Pennsylvania in Philadelphia, PA. A two-phase study is proposed with an initial 1-year developmental phase (R61) that will develop and pilot test STORC to include support person training. A second 4-year phase (R33) will test STORC in a parallel, two-arm, randomized controlled trial design at two study sites.

Conditions

Opioid Use Disorder

Keywords

Patient Navigation

Outcome Measures

Primary Outcomes (2)

• Recruitment Feasibility

  Number of eligible participants recruited for the trial relative to the number screened.

  at study completion, up to 3 months

• Acceptability of the Intervention

  Intervention acceptability will be measured using the 4-item Acceptability of Intervention Measure (AIM), a valid and reliable self-report measure of the extent to which participant accepts the intervention as relevant to their experience. The AIM is scored from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.

  At 3 month follow-up

Secondary Outcomes (4)

• Appropriateness of the Intervention

  at 3 month follow-up

• Recovery Capital

  Changes from baseline to 3 months follow-up

• Self-efficacy

  Changes from baseline to 3 months

• Substance use

  The past 30 days

Study Arms (1)

STORC

EXPERIMENTAL

STORC is inclusive of patient navigation and support person training.

Behavioral: STORC

Interventions

STORC BEHAVIORAL

STORC will operate as a service model integrating both designated support persons and specialized patient navigators to enhance recovery capital and improve secondary outcomes, including increased OAT retention.

STORC

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be biological females
• must be currently within 6 weeks postpartum
• must be able to read, write, and speak English at a 6th-grade level
• must be diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder at the PROUD clinic
• must identify a support person who also consents to participate. Patient participants must identify prospective support persons in order to complete consent

You may not qualify if:

• pregnancy
• planned discharge to a long-term inpatient care facility (e.g., hospice)
• hospitalization for a suicide attempt
• major mental health disorder that requires treatment before OAT can be considered
• stillbirth or neonatal death of the index pregnancy/infant, as determined from the obstetric record.

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karen Alexander

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Alexander, PhD

CONTACT

9084510141; kalexander@friendsresearch.org

Rachel Woolworth, MSW

CONTACT

267-258-2067; rwoolworth@friendsresearch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Support person training. Support persons will engage in online training. The training videos will be divided into three main modules. Module 1 will focus on building social and community capital, providing knowledge about OUD recovery, treatment, and processes of change. Module 2 will detail coping skills and emotional support resources for the support persons. Also included will be a discussion of healthy boundaries. In Module 3, a review of the skills learned will be included and effective communication skills will be further developed between support person and their loved one, and between support person and healthcare providers. Patient Navigation. The video training will be integrated alongside patient navigation, as an evidence-based intervention. Patient navigation addresses health beliefs, motivations, and barriers to engaging with services, including addressing social and material needs .

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 26, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)