Perinatal Opioid Use DisorderPENNY-COPILOTNCT06969261
Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
A study testing Penny COPILOT in people with Perinatal Opioid Use Disorder and Opioid Use Disorder, run by University of Pennsylvania at 2 sites in United States.
Trial summary
To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Opioid Use Disorder, Opioid Use Disorder
- What is being tested?
- Penny COPILOT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2026to 31 May 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biological females who are currently pregnant or within 6 weeks postpartum.
- Able to read, write, and speak English at a 6th grade level.
- Diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder.
- Receiving prenatal care and OUD care at a Penn affiliated hospital.
Who cannot join
- -Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hospital of the University of Pennsylvania (HUP)
Philadelphia, Pennsylvania, 19072
Emma Farber, BA, 215-746-3338, emma.farber@pennmedicine.upenn.edu
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309
Sara L Kornfield, PhD, 800-789-7633, sarakorn@pennmedicine.upenn.edu
About this study
To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.
Read the detailed description
The opioid use epidemic in the US disproportionately affects women of childbearing age which is evidenced by a 131% in OUD among women giving birth in hospitals from 2010-2017. Substance use in pregnancy increases the risks for a host of maternal and infant medical complications including preterm delivery and intrauterine fetal demise, as well as maternal morbidity and mortality caused by drug overdose. Increasing fatalities due to overdose in Philadelphia specifically have been attributed to decreased access to social support and treatment services. Loneliness and social isolation are implicated as risk factors for initiation and maintenance of OUD and are heighted in the perinatal period. Perinatal OUD care requires frequent contact with providers which may not always be feasible as in-person visits or phone calls to a clinician's office are restricted to business hours and may require a wait time before the necessary attention can be given. In order to increase patient access to OUD and perinatal care, decrease loneliness and a sense of social isolation, and promote engagement in care, we now embark on a study utilizing steps from intervention mapping to identify, develop, and refine content and delivery methods for an adaptation to a two-way short messaging service (SMS) texting chatbot to make it appropriate for perinatal women with OUD.
In Aim 1, we will conduct a needs assessment via in-depth interviews with up to 36 perinatal patients with OUD (12), their partners (12), and their clinicians (12). We will convene an advisory board and used mixed methods analyses to investigate the qualitative data to determine the content to be included and the delivery methods to use in the adapted Chatbot.
In Aim 2, we will pretest with adapted Chatbot with 10 perinatal patients with OUD in order to develop and refine the anticipatory guidance, establish clinical teams, ensure the safety of the protocol, and evaluate the user experience.
In Aim 3, we will pilot test the adapted Chatbot with 20 perinatal patients with OUD. We will conduct a focus group on 10 individuals participating in the pilot study to examine the acceptability, and feasibility of the intervention. We will also collect initial effectiveness data on the Chatbot's effect on loneliness, social isolation, opioid use, mental health and healthcare engagement via self-report surveys and electronic medical record data extraction.
- Conditions
- Perinatal Opioid Use Disorder, Opioid Use Disorder
- Being tested
- Penny COPILOT
- Keywords
- Maternal Health, Maternal Substance Use, Perinatal OUD, Chatbot, mHealth Interventions, Loneliness
- 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.
Penny COPILOTBehavioural
The Penny COPILOT chatbot is an interactive short messaging system (SMS) program that provides educational and supportive content for postpartum individuals. The chatbot has been adapted to include information relevant to opioid use disorder recovery in order to decrease the risk of returning to use among people who use drugs. Messages are sent at specified intervals relevant to the postpartum course and the chatbot allows for two way messaging with an interactive lens.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Intervention | Experimental | This is a single arm study designed to assess the acceptability and feasibility of the chatbot. Receives: Behavioral: Penny COPILOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale.
The UCLA Loneliness Scale (Version 3) is the most commonly used measure of loneliness, with strong test-retest reliability, high internal consistency, and validity.97 While the word "lonely" is never used explicitly in the 20-item scale, subjects are asked to report the frequency of specific experiences (e.g., "How often do you feel in tune with others around you?") on a 4-point Likert scale (1 = "I never feel this way" to 4 = "I often feel this way.") For dichotomous analysis of loneliness, we will use the loneliness severity threshold adapted from Doryab98 which defines "lonely" as having a score greater than 40, while "not lonely" is defined as having a score less than or equal to 40.
Measured: During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.
Secondary outcomes (1)
Opioid use questionnaire
A questionnaire designed by our investigative team that queries a participant's opioid use, specifically identifying their drug of choice, method of administration, pattern of use, triggers for use, frequency and amount of use, barriers to relapse, and recency of relapse.
Measured: During Aim 3 activities, assessments will occur at Baseline and 3-month Follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sara L Kornfield, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969261
- Sponsor's protocol ID
- 853729
- Other IDs
- R34DA058461
- Acronym
- PENNY-COPILOT
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified demographic data and responses to survey items will be shared by appropriate request to the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
- ClinicalTrials.gov ID
- NCT06969261
- Acronym / sponsor ID
- PENNY-COPILOT / 853729
- Conditions
- Perinatal Opioid Use Disorder, Opioid Use Disorder
- Keywords
- Maternal Health, Maternal Substance Use, Perinatal OUD, Chatbot, mHealth Interventions, Loneliness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 May 2025 (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.
To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.
Detailed description
The opioid use epidemic in the US disproportionately affects women of childbearing age which is evidenced by a 131% in OUD among women giving birth in hospitals from 2010-2017. Substance use in pregnancy increases the risks for a host of maternal and infant medical complications including preterm delivery and intrauterine fetal demise, as well as maternal morbidity and mortality caused by drug overdose. Increasing fatalities due to overdose in Philadelphia specifically have been attributed to decreased access to social support and treatment services. Loneliness and social isolation are implicated as risk factors for initiation and maintenance of OUD and are heighted in the perinatal period. Perinatal OUD care requires frequent contact with providers which may not always be feasible as in-person visits or phone calls to a clinician's office are restricted to business hours and may require a wait time before the necessary attention can be given. In order to increase patient access to OUD and perinatal care, decrease loneliness and a sense of social isolation, and promote engagement in care, we now embark on a study utilizing steps from intervention mapping to identify, develop, and refine content and delivery methods for an adaptation to a two-way short messaging service (SMS) texting chatbot to make it appropriate for perinatal women with OUD.
In Aim 1, we will conduct a needs assessment via in-depth interviews with up to 36 perinatal patients with OUD (12), their partners (12), and their clinicians (12). We will convene an advisory board and used mixed methods analyses to investigate the qualitative data to determine the content to be included and the delivery methods to use in the adapted Chatbot.
In Aim 2, we will pretest with adapted Chatbot with 10 perinatal patients with OUD in order to develop and refine the anticipatory guidance, establish clinical teams, ensure the safety of the protocol, and evaluate the user experience.
In Aim 3, we will pilot test the adapted Chatbot with 20 perinatal patients with OUD. We will conduct a focus group on 10 individuals participating in the pilot study to examine the acceptability, and feasibility of the intervention. We will also collect initial effectiveness data on the Chatbot's effect on loneliness, social isolation, opioid use, mental health and healthcare engagement via self-report surveys and electronic medical record data extraction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chatbot Intervention | Experimental | Behavioral: Penny COPILOTThis is a single arm study designed to assess the acceptability and feasibility of the chatbot. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Biological females who are currently pregnant or within 6 weeks postpartum.
- Able to read, write, and speak English at a 6th grade level.
- Diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder.
- Receiving prenatal care and OUD care at a Penn affiliated hospital.
Key exclusion criteria (1 listed)
- -Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).
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 |
|---|---|---|
| Penny COPILOTThe Penny COPILOT chatbot is an interactive short messaging system (SMS) program that provides educational and supportive content for postpartum individuals. The chatbot has been adapted to include information relevant to opioid use disorder recovery in order to decrease the risk of returning to use among people who use drugs. Messages are sent at specified intervals relevant to the postpartum course and the chatbot allows for two way messaging with an interactive lens. | Behavioural | Chatbot Intervention |
Primary outcome
UCLA Loneliness Scale.
Time frame: During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.
The UCLA Loneliness Scale (Version 3) is the most commonly used measure of loneliness, with strong test-retest reliability, high internal consistency, and validity.97 While the word "lonely" is never used explicitly in the 20-item scale, subjects are asked to report the frequency of specific experiences (e.g., "How often do you feel in tune with others around you?") on a 4-point Likert scale (1 = "I never feel this way" to 4 = "I often feel this way.") For dichotomous analysis of loneliness, we will use the loneliness severity threshold adapted from Doryab98 which defines "lonely" as having a score greater than 40, while "not lonely" is defined as having a score less than or equal to 40.
1 secondary outcome
Opioid use questionnaire
Time frame: During Aim 3 activities, assessments will occur at Baseline and 3-month Follow-up.
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified demographic data and responses to survey items will be shared by appropriate request to the study PI.
Related trials for Perinatal Opioid Use Disorder
Recruiting
Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment
Substance Use Treatment, Perinatal Substance Use
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.
Sara L Kornfield, PhD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penny COPILOT in people with Perinatal Opioid Use Disorder and Opioid Use Disorder, run by University of Pennsylvania at 2 sites 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 4 inclusion and 1 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sara L Kornfield, PhD (1-800-789-7366, sarakorn@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Loneliness Scale. (time frame: During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.). 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 28 Jul 2026.