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

32 Participants Needed

Trial Summary

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 data supports the idea that Digital Support for Opioid Addiction is an effective treatment?

The available research shows that digital support for opioid addiction can be effective. One study reviewed digital interventions and found they can be used alongside traditional face-to-face treatments to help people with opioid use disorder. Another study tested a mobile app called 'uMAT-R' and found it helped people understand medication-assisted treatment better, which is important for starting treatment. Additionally, a clinical trial showed that a digital therapeutic used with a medication called buprenorphine was safe and effective for people seeking treatment for opioid use disorder. These findings suggest that digital support can be a helpful part of treating opioid addiction. ^{1 2 3 4 5}

What data supports the effectiveness of the Digital Support Intervention treatment for opioid addiction?

Research shows that digital interventions, like mobile apps, can help people with opioid addiction by providing information and support, which can improve their understanding and use of medication-assisted treatment. These digital tools are low-cost and accessible, making them a promising option for supporting recovery. ^{1 2 3 4 5}

What safety data exists for digital support in opioid addiction treatment?

The safety of digital support for opioid addiction has been evaluated in a randomized clinical trial (NCT00929253) that assessed a prescription digital therapeutic as an adjunct to buprenorphine for opioid use disorder. This suggests that there is some clinical trial data available on the safety of such digital interventions. ^{2 3 5 6 7}

Is digital support for opioid addiction safe for humans?

Research shows that digital tools, like mobile apps and web-based interventions, have been used safely alongside treatments for opioid addiction. These tools help deliver information and support without adding significant risks to users. ^{2 3 5 6 7}

Is the Digital Support Intervention a promising treatment for opioid addiction?

Yes, the Digital Support Intervention is promising because it can provide accessible and low-cost support for people with opioid addiction. It helps improve understanding of medication-assisted treatment, supports ongoing treatment, and can be used alongside traditional methods to enhance recovery. ^{1 2 3 8 9}

How is the Digital Support Intervention treatment for opioid addiction different from other treatments?

The Digital Support Intervention is unique because it uses digital tools, like mobile apps, to provide psycho-social support and information about medication-assisted treatment (MAT) for opioid addiction. This approach can be more accessible and cost-effective, offering support outside traditional face-to-face settings. ^{1 2 3 8 9}

What is the purpose of this trial?

The goal of this pilot randomized feasibility study is to explore the benefits of providing parenting and recovery support for pregnant people with Opioid Use Disorders through digital technology (e.g. smartphones). The main question it aims to answer is: • What is the feasibility of providing customized digital parenting and recovery supports to pregnant people with Opioid Use Disorders residing in natural communities? o Feasibility data includes data on study interest, eligibility, time to enroll, participant training on digital app usage, attrition; Secondary outcome exploratory data will include MOUD treatment retention, missed follow up prenatal and early postpartum appointments, drug usage, and parenting outcomes (i.e., scores on the Parental sense of competency scale, Self-rated abilities for health practices scale, and Self-efficacy in infant care scale) through self-report; The intervention group only will also be observed regarding app usage, frequency of use, resources accessed, thoughts about the app, and what was found to be helpful. Researchers will compare the bibliotherapy control group to determine clinical differences in secondary outcomes. Participants will complete the following tasks: * Schedule an online meeting with the research team to receive more information about the study. Once consented to participate, the participant will be randomly assigned to one of the groups. * Complete survey questions within one week after agreeing to participate in the study, after 6 weeks, and 12 weeks. The surveys include questions about drug usage, missed follow-up medical appointments, and parenting outcomes. The total time to complete the survey after consenting to be in the study will take approximately 40 minutes. The total time to complete the surveys after the six week and 12-week study period should take no more than 30 minutes. * Complete a one-hour virtual interview at three months post-delivery (by phone or computer) about the study experience.

Research Team

Phyllis A Raynor, PHD

Principal Investigator

University of South Carolina

Eligibility Criteria

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

I am a pregnant woman more than 13 weeks along.

Able to speak and understand English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Digital interventions for opioid use disorder treatment: A systematic review of randomized controlled trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Patient Engagement in a Multimodal Digital Phenotyping Study of Opioid Use Disorder. [2023]

5. England 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. [2022]

6. Switzerland 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018]

8. Switzerland 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. [2022]

9. United States 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. [2023]