Penny COPILOT for Opioid Use Disorder

(PENNY-COPILOT Trial)

Overseen By Sara L Kornfield, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Opioid treatments

Disqualifiers: Untreated psychosis, mania, suicidality

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new supportive texting chatbot called Penny COPILOT, designed to assist pregnant and postpartum women with opioid use disorder (OUD). The researchers aim to determine if the chatbot reduces loneliness and keeps users engaged in their healthcare. Participants will evaluate the chatbot's helpfulness and ease of use. Women who are pregnant or recently had a baby, can read English, and are receiving treatment for OUD at a Penn hospital may qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for OUD support during pregnancy and postpartum.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a texting support chatbot for women with opioid use disorder.

What prior data suggests that the Penny COPILOT chatbot is safe for perinatal women with OUD?

Research has shown that the Penny COPILOT chatbot is a new tool designed to assist women with opioid use disorder (OUD) during and after pregnancy. Although specific safety data for this chatbot is not available, it is important to note that Penny COPILOT does not involve medication. Instead, it functions as a texting service aimed at reducing loneliness and improving care engagement.

As a digital tool, it presents much lower risks compared to traditional drug treatments. The primary goal is to ensure that its messages are helpful and appropriate. The team developing Penny COPILOT will carefully test and refine the chatbot's content to ensure it remains safe and supportive for users.

In summary, using Penny COPILOT carries very low risk because it is an interactive texting service, not a physical treatment or medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Penny COPILOT for opioid use disorder because it introduces an innovative approach using a chatbot intervention. Unlike traditional treatments like medication-assisted therapy (MAT) with methadone, buprenorphine, or naltrexone, Penny COPILOT leverages technology to provide support and guidance through an interactive platform. This method aims to be a more accessible and scalable option, reaching individuals who might not have easy access to in-person therapy or medication. By focusing on acceptability and feasibility, Penny COPILOT has the potential to complement existing therapies and broaden the scope of care for those struggling with opioid use disorder.

What evidence suggests that the Penny COPILOT chatbot is effective for opioid use disorder?

Research has shown that AI chatbots like Penny COPILOT can assist pregnant women with opioid use disorder (OUD) by reducing loneliness and enhancing their involvement in care. Early findings suggest that chatbots offer supportive communication, which encourages patients to actively manage their health. Studies have demonstrated that regular, supportive interaction leads to better health outcomes by keeping patients more connected to their healthcare team and treatment plans. Although specific data on Penny COPILOT's effectiveness is still being collected, this approach relies on proven strategies that improve patient engagement and satisfaction in healthcare. ^{1 2 4 5 6}

Who Is on the Research Team?

Sara L Kornfield, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for perinatal women who are currently pregnant or postpartum and struggling with opioid use disorder (OUD). It aims to help them feel less lonely and more engaged in their care. The eligibility criteria have not been detailed, but typically would include factors like age range, specific health conditions related to pregnancy and OUD, and willingness to participate.

Inclusion Criteria

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

I am currently pregnant or have given birth in the last 6 weeks.

Exclusion Criteria

Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretesting

Pretesting to ensure safety and refine content of the Penny COPILOT chatbot

4 weeks

Pilot Testing

Pilot test the adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction

3 months

Assessments at Baseline and 3-month Follow-up

Follow-up

Participants are monitored for safety and effectiveness after pilot testing

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Penny COPILOT

Trial Overview The trial is testing Penny COPILOT, an adapted version of a texting support chatbot designed for perinatal women with OUD. It involves two-way SMS messaging that can respond accurately to user input. The process includes needs assessment, advisory board feedback, pretesting for safety/content refinement, and pilot testing for acceptability.

How Is the Trial Designed?

Group I: Chatbot Intervention Experimental Treatment 1 Intervention

This is a single arm study designed to assess the acceptability and feasibility of the chatbot.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10684535

Adapting the Penny Chatbot for Perinatal OUD Patients In order to adapt an existing supportive texting chatbot to decrease feelings of loneliness and increase engagement in OUD and perinatal care, we now embark on ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-6-2025-110d3

Penny COPILOT for Opioid Use Disorder The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care ...

3. reporter.nih.gov reporter.nih.gov/search/NVKuxbzo-0GpaWWIDhmMoQ/project-details/11037080

Project Details Finally, in Aim 3, we will identify the optimized chatbot package that is effective, producing the best expected improvement in ED outcomes, while remaining ...

4. nursing.missouri.edu nursing.missouri.edu/ai-chatbots-can-help-pregnant-women-with-opioid-use-disorder-new-study-finds/

AI chatbots can help pregnant women with opioid use disorder ... AI chatbots can help pregnant women with opioid use disorder, new study finds. SSON researchers explore how GPT-4 can be fine-tuned to give ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0110310

Opioid Use Disorder (OUD) (DBCOND0110310) - DrugBank Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT, No drug interventions, supportive_care, Not Available, not_yet_recruiting. Sign up for a demo of ...

6. med.upenn.edu med.upenn.edu/pisce/january-2024-newsletter.pdf

January 2024 Newsletter PISCE's Upcoming Events Sara Kornfield was awarded an R34 by adapting a chatbot,. Penny COPILOT, to address both loneliness and engagement in perinatal and opioid use.