Recruiting

STORC

Sponsor:

Friends Research Institute, Inc.

Code:

NCT07787039

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STORC

Study Details

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

Study ID

NCT07787039

Start date

Sep 26, 2026

Status verified date

Oct, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: STORC

STORC is inclusive of patient navigation and support person training.

Interventions

STORC

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.

Primary outcome measure

  • Recruitment Feasibility [ Time Frame: at study completion, up to 3 months ]
  • Acceptability of the Intervention [ Time Frame: At 3 month follow-up ]

Central Contacts and Locations

Central contacts

Karen Alexander, PhD

9084510141kalexander@friendsresearch.org

Rachel Woolworth, MSW

267-258-2067rwoolworth@friendsresearch.org

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Karen Alexander, PhD

9084510141kalexander@friendsresearch.org

Sara Kornfield, PhD

215-746-1255sarakorn@pennmedicine.upenn.edu

Principal Investigator:

Sara Kornfield, PhD

More Information

Sponsor

Friends Research Institute, Inc.

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Patient Navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Friends Research Institute, Inc. on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.