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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sara L Kornfield, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+