An interventional study of STORC in Opioid Use Disorder, sponsored by Friends Research Institute, Inc.. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Friends Research Institute, Inc. · Not applicable, Interventional, and Supportive care
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.
The developmental R61 phase will focus on developing training materials and pilot testing STORC for feasibility and acceptability. This will be accomplished through three interrelated processes: 1) Developing materials to train support persons, including creating digital education content with expert consultants; 2) Pilot testing STORC recruitment procedures and training content to evaluate feasibility and acceptability; 3) Conducting qualitative interviews to gain diverse stakeholder input at the end of the pilot trial; and 4) Refining training materials into a final digital product with our media consultant.
Aim 1 (Months 2-12): We will develop and refine training materials to create a robust support person training. We will do this through an iterative process that first uses feedback from expert consultants with lived experience (two of whom are certified recovery specialists working in the PROUD clinic). These experts will develop scripts to communicate the training content to support persons, and we will work with our media production partner to produce the video content. After the pilot trial in Aim 2, we will refine the content and update any training portions that need improvement after qualitative interviews.
Aim 2: (Months 4-10) Pilot test STORC for feasibility and acceptability (N = 20 [10 patient/support person dyads]) and refine with feedback from the dyads at completion of the pilot. All participants will also view the training videos and provide feedback. The qualitative feedback and results of the pilot testing will inform the final STORC protocol used in the R33 phase.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 10 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Friends Research Institute, Inc. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
STORC is inclusive of patient navigation and support person training.
Behavioral: 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.
Recruitment Feasibility
Number of eligible participants recruited for the trial relative to the number screened.
Time frame: 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.
Time frame: At 3 month follow-up
Appropriateness of the Intervention
Intervention appropriateness will be measured using the 4-item Intervention Appropriateness Measure (IAM), a valid and reliable self-report measure of the extent to which participants see the intervention as appropriate for who they are and their experience. The IAM is scored from 1 to 5, with higher scores indicating greater perceived appropriateness of the intervention.
Time frame: at 3 month follow-up
Recovery Capital
Recovery Capital will be assessed using the Brief Assessment of Recovery Capital-10 (BARC-10). The BARC-10 is scored from 10 to 60, with higher scores indicating greater recovery capital.
Time frame: Changes from baseline to 3 months follow-up
Self-efficacy
The degree to which a person is confident they can make a change in health related behavior measured using the Patient Activation Measured (PAM). The PAM-10 is scored from 0 to 100, with higher scores indicating greater patient activation, reflecting greater knowledge, skills, and confidence in managing one's health and healthcare.
Time frame: Changes from baseline to 3 months
Substance use
Timeline follow-up of substance use in the past 30 days measured by number of days of substance use during the past 30 days, assessed at each follow-up visit.
Time frame: The past 30 days
Plan to share: Yes — Deidentified data will be published after study completion.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Friends Research Institute, Inc.