Digital Support for Opioid Addiction

(PARENTSS Trial)

Overseen By Phyllis A Raynor, PHD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of South Carolina

Must be taking: MOUD

Disqualifiers: Not pregnant, Violent criminal history, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how digital support through smartphones can assist pregnant individuals with opioid addiction in managing their recovery and parenting. Researchers aim to assess the usability of a digital app, the Digital Support Intervention, which provides customized resources for recovery and parenting. Participants are divided into two groups: one uses the app, while the other receives a parenting book. The trial seeks pregnant individuals with an opioid use disorder who live in their natural home environment. As an Early Phase 1 trial, this research focuses on understanding how the digital support intervention functions in people, offering participants a chance to experience this innovative approach firsthand.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves participants with Opioid Use Disorders, it is likely that you will need to continue any current treatment for opioid use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on digital support for opioid addiction, so it's best to discuss your current medications with the research team during the initial meeting.

What prior data suggests that this digital support intervention is safe for pregnant people with Opioid Use Disorders?

Research has shown that digital tools, such as smartphone apps, can assist in managing opioid use disorder (OUD). Past studies have used these tools to track and predict opioid use, providing support for individuals in recovery. However, detailed safety information for this specific digital tool is not yet available.

This is an early-stage trial, meaning the treatment is still being tested for safety and efficacy. In these early trials, researchers primarily assess the treatment's safety for participants. While initial evidence suggests these tools might be beneficial, further research is necessary to confirm their safety and effectiveness for everyone, particularly for pregnant individuals with OUD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Support Intervention for opioid addiction because it leverages technology to provide personalized support. Unlike traditional treatments such as medication-assisted therapy or behavioral counseling, this intervention uses a smartphone app to offer comprehensive resources tailored to both parenting and recovery. This unique approach allows participants to access help anytime, which could enhance engagement and adherence to recovery plans. Additionally, by integrating parenting support, it addresses a critical aspect of life that can influence recovery success.

What evidence suggests that this digital support intervention is effective for opioid addiction?

This trial will compare a Customized Digital Application group with a Parenting book support group. Research has shown that digital tools, such as smartphone apps, can assist people with opioid use disorder (OUD). Studies have found that app-based support, when combined with medication for OUD, can improve treatment outcomes. Many individuals find these digital tools helpful and supportive in their recovery. Apps with features like daily check-ins or reminders help people stay focused on their recovery goals. Overall, these digital supports show promise for those seeking to enhance their recovery journey. ^{2 6 7 8 9}

Who Is on the Research Team?

Phyllis A Raynor, PHD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with Opioid Use Disorders. Participants should be interested in using digital technology to receive parenting and recovery support, and willing to engage in study activities like surveys and virtual interviews. There's no detailed exclusion criteria provided.

Inclusion Criteria

Able to speak and understand English

I am a pregnant woman more than 13 weeks along.

Residing in natural home environment

Exclusion Criteria

Not pregnant, has active illicit opioid use and not currently in treatment

A violent criminal history

I cannot read or communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 virtual meeting

Treatment

Participants receive digital parenting and recovery support through a smartphone app

12 weeks

Surveys at baseline, 6 weeks, and 12 weeks

Follow-up

Participants complete a qualitative interview about their study experience and treatment retention

3 months post-delivery

1 virtual interview

What Are the Treatments Tested in This Trial?

Interventions

• Digital Support Intervention

Trial Overview

The study tests a digital support intervention via smartphones against bibliotherapy (reading materials) for aiding pregnant people with opioid addiction. It measures the ease of implementing such digital interventions, their impact on treatment retention, missed medical appointments, drug use, and parenting skills.

How Is the Trial Designed?

Group I: Customized Digital Application group (Intervention) Experimental Treatment 1 Intervention

Participants are assigned to one of two groups where they will receive one type of parenting support. The intervention group will receive a smartphone app which provides access to comprehensive resources related to parenting and recovery. The intervention group will be observed to determine how frequently they use the digital app, thoughts about it, and what was found to be helpful. This will occur over a 12-week period. The intervention group will complete surveys over the study period through the digital app. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery.

Group II: Parenting book as support for control group Active Control 1 Intervention

The bibliotherapy control group will receive a book on what to expect as a parent the first year after delivery. The control group will complete surveys over the study period and are given the option to complete surveys by phone or videoconference with a Team member. The times for survey completion are within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about personal history, drug usage and cravings, missed follow-up medical appointments, and parenting outcomes. An interview with the PI at 12 weeks post-delivery.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Published Research Related to This Trial

Digital interventions for treating opioid use disorder, including methods like mobile apps and video conferencing, were found to be generally acceptable and satisfactory to participants, with 10 out of 20 studies showing significant improvements in opioid abstinence.

The effectiveness of these digital interventions varied, with some studies demonstrating better treatment retention, highlighting the need for further research to explore their impact in diverse populations, especially in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for opioid use disorder treatment: A systematic review of randomized controlled trials. Kiburi, SK., Ngarachu, E., Tomita, A., et al.[2023]

In a study of 180 individuals with opioid use disorders in Nairobi, Kenya, 77.2% owned mobile phones, with a high acceptability (95%) for receiving treatment via phone, particularly through text messages.

The study identified key factors influencing the acceptability of digital interventions, including education level, single marital status, smartphone ownership, and employment, which are important for designing effective digital treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone ownership, digital technology use and acceptability of digital interventions among individuals on opioid use disorder treatment in Kenya. Kiburi, SK., Paruk, S., Chiliza, B.[2022]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

Health information technologies, like mobile phone applications and electronic health records, can improve treatment outcomes for people with substance use disorders by making evidence-based therapies more accessible and easier to implement.

A clinical case demonstrated that using text messaging for communication between a buprenorphine provider and a patient allowed for effective home induction onto buprenorphine, showing a practical application of technology in managing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. Tofighi, B., Grossman, E., Sherman, S., et al.[2018]

In a study of 65 patients receiving buprenorphine for opioid use disorder, participants showed high engagement with digital phenotyping methods, meeting phone carrying criteria on 94% of study days and watch wearing criteria on 74% of days, indicating strong potential for real-time monitoring.

Despite high engagement with phone and smartwatch data, social media data collection was less consistent, with only 55-57% of participants providing data from platforms like Facebook and Instagram, suggesting a need for improved strategies to enhance social media data utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Engagement in a Multimodal Digital Phenotyping Study of Opioid Use Disorder. Campbell, CI., Chen, CH., Adams, SR., et al.[2023]

A scoping review of 16 studies from Canada and Australia highlighted that digital health initiatives, particularly telehealth and mobile applications, are effective in preventing opioid-related harm and deaths, especially during the COVID-19 pandemic.

Telehealth for opioid replacement therapy showed similar effectiveness and retention rates as in-person treatments, while mobile apps linked to emergency services demonstrated lifesaving potential for overdose prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Interventions to Save Lives From the Opioid Crisis Prior and During the SARS COVID-19 Pandemic: A Scoping Review of Australian and Canadian Experiences. Donnell, A., Unnithan, C., Tyndall, J., et al.[2022]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

A study involving 24 adults in outpatient buprenorphine treatment found that a computer- and text message-based intervention is highly acceptable and can effectively support recovery by reducing stigma and enhancing learning.

Participants preferred a personalized intervention that includes both automatic and on-demand text messages, suggesting that incorporating multimedia elements could further improve engagement and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a digital health intervention to promote engagement in and adherence to medication for opioid use disorder. Langdon, KJ., Scherzer, C., Ramsey, S., et al.[2023]

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