Opioid Use DisorderSTORC R61NCT07787039
Supporting Treatment for Opioids and Recovery Capital (STORC) - R61 Phase
A study testing STORC in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- STORC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Karen Alexander, PhD, 9084510141, kalexander@friendsresearch.org
Sara Kornfield, PhD, 215-746-1255, sarakorn@pennmedicine.upenn.edu
About this study
Official title: Empowering Support Persons to Enhance the Recovery Capital of Postpartum Women With Opioid Use Disorder - R61 Phase
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.
Read the detailed description
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.
- Conditions
- Opioid Use Disorder
- Being tested
- STORC
- Keywords
- Patient Navigation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STORCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STORC | Experimental | STORC is inclusive of patient navigation and support person training. Receives: Behavioral: STORC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Number of eligible participants recruited for the trial relative to the number screened.
Measured: 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.
Measured: At 3 month follow-up
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start26 Sep 2026
- Primary completion30 Sep 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 .
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Karen Alexander, Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787039
- Sponsor's protocol ID
- R61DA064704
- Other IDs
- R61DA064704
- Acronym
- STORC R61
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be published after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Support Persons to Enhance the Recovery Capital of Postpartum Women With Opioid Use Disorder - R61 Phase
- ClinicalTrials.gov ID
- NCT07787039
- Acronym / sponsor ID
- STORC R61 / R61DA064704
- Conditions
- Opioid Use Disorder
- Keywords
- Patient Navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Sep 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| STORC | Experimental | Behavioral: STORCSTORC is inclusive of patient navigation and support person training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STORCSTORC 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. | Behavioural | STORC |
Primary outcome
Recruitment Feasibility
Time frame: at study completion, up to 3 months
Number of eligible participants recruited for the trial relative to the number screened.
Acceptability of the Intervention
Time frame: At 3 month follow-up
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.
4 secondary outcomes
Appropriateness of the Intervention
Time frame: at 3 month follow-up
Recovery Capital
Time frame: Changes from baseline to 3 months follow-up
Self-efficacy
Time frame: Changes from baseline to 3 months
Substance use
Time frame: The past 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be published after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Alexander principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STORC in people with Opioid Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Alexander, PhD (9084510141, kalexander@friendsresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: at study completion, up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.