Smartphone App for Opioid Addiction Recovery

(SOAR Trial)

Recruiting at 1 trial location

Overseen By Paul Glimcher

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NYU Langone Health

Must be taking: Methadone, Buprenorphine

Must not be taking: Benzodiazepines, Sedatives

Disqualifiers: Severe mental disorder, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to assist people recovering from opioid addiction. The app aims to predict and reduce the likelihood of illicit opiate use during treatment. Participants will either use the app or receive their usual treatment for opioid addiction. Individuals diagnosed with opioid-use disorder who have used non-prescribed opioids in the last 30 days might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants should be in a treatment program that prescribes methadone or buprenorphine, so you may need to continue those medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that smartphone apps for aiding recovery from opioid addiction are generally user-friendly. Previous studies have found these apps safe and effective for managing opioid use disorder. For instance, some apps use sensors to track breathing and detect possible overdoses, sending timely alerts to help without harming users.

Another study examined mental health apps for substance use disorders and found that people are interested in using these technologies, indicating a positive response and few negative reactions. While these studies did not identify major safety issues, it is important to note that this trial is in a late stage, which usually means the treatment has already passed earlier safety tests.

Overall, these smartphone apps seem to be a safe option for supporting people in their recovery journey. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Smartphone App for Opioid Addiction Recovery because it introduces a fresh approach to managing opioid addiction through technology. Unlike traditional treatments like medication-assisted therapy or counseling, this app uses interactive elements like brief questionnaires and short games to engage users in their recovery process. The app's flexibility allows it to personalize treatment, potentially increasing patient engagement and adherence. This innovative method aims to provide support that is both accessible and adaptable, offering a new avenue for individuals seeking an alternative or supplement to existing treatments.

What evidence suggests that this smartphone app is effective for opioid addiction recovery?

Research has shown that smartphone apps can help people use fewer opioids and remain in treatment longer. In this trial, participants in the "Smartphone with dose changes before using" and "Smartphone with dose changes after using" groups will have an app installed on their phones. One study found that using an app alongside medication reduced the number of days patients used opioids. The app offers quick daily check-ins and games that help predict if someone might soon use opioids again. Studies indicate that people who use these apps, along with their regular treatment, achieve better recovery outcomes. By helping people track their behavior, these apps provide extra support for overcoming addiction. ^{1 3 6 7 8}

Who Is on the Research Team?

Stephen Ross, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with opioid-use disorder who are entering or planning to enter a treatment program using methadone or buprenorphine. Participants must be in stable health, able to understand and consent to the study in English, and have used opioids recently. Excluded are those with severe pain requiring opioids, pregnant or breastfeeding women, prisoners, individuals under court-ordered treatment, and those with serious medical or mental conditions.

Inclusion Criteria

Clinician Participants must be licensed MSWs, NPs, or MDs who are not part of any treatment team within the study and may be employees of their respective sites or other treatment facilities

I am in or plan to join a treatment program for opioid use that includes methadone or buprenorphine.

Patients must meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)

Exclusion Criteria

Patients with pending legal action or other reasons that might prevent an individual from completing the study

Patients with serious medical, psychiatric, or non-opioid substance use disorder that, in the opinion of a study physician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study

I need opioids to manage my severe pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with buprenorphine and methadone, with dose adjustments based on smartphone app data

6 months

Bi-weekly visits for saliva drug tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Focus Group Sessions

Study physicians and clinicians participate in focus group sessions or 1:1 interviews

Annually over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Smartphones for Opiate Addiction Recovery

Trial Overview The trial is testing a smartphone app designed to predict the likelihood of illicit opiate use within the next week among patients undergoing addiction treatment. The goal is to reduce illicit opiate use during recovery by providing timely interventions based on these predictions.

How Is the Trial Designed?

Group I: Smartphone with dose changes before using Experimental Treatment 1 Intervention

Participants will have an app installed on their phone and have to complete a brief questionnaire and some days to play a 2-4 minute game.

Group II: Smartphone with dose changes after using Experimental Treatment 1 Intervention

Participants will have an app installed on their phone and have to complete a brief questionnaire and some days play a 2-4 minute game.

Group III: Focus group with Study Physicans Experimental Treatment 1 Intervention

Study physicians asked to participate in a focus group session or 1:1 interviews if unable to attend the focus group during year one of the study and once annually towards the end of years 2, 3, 4, and 5 of the study

Group IV: Focus group with Clinicians Experimental Treatment 1 Intervention

Clinicians asked to participate in a 1:1 interview and a separate focus group at roughly the same time. Prior to the first structured interview with our study team, you will participate in a 1-hour training and familiarization session with the SOAR system using synthetic or training data.

Group V: Treatment-as-Usual Active Control 1 Intervention

Participants will receive the same treatment as if they had not joined the study

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The study aims to review the current landscape of mobile apps designed to prevent and manage opioid-related harm, highlighting their potential as a public health intervention.

The review will analyze various aspects of these apps, including their availability across different operating systems, features, target user groups, and user ratings, to assess their effectiveness and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Mobile Apps for Prevention and Management of Opioid-Related Harm. Aggarwal, M., Borycki, EM.[2019]

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]

This study will evaluate the effectiveness of combining medication-assisted treatment (MAT) with a smartphone innovation called A-CHESS in 440 patients with opioid use disorder over a 24-month period, aiming to reduce illicit opioid use.

The primary outcome will measure the percentage of days using illicit opioids, while secondary outcomes will assess various factors including substance use, quality of life, and health service utilization, potentially improving recovery rates and access to treatment for opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial. Gustafson, DH., Landucci, G., McTavish, F., et al.[2022]

In a study of 414 participants over 16 months, combining medication for opioid use disorder (MOUD) with the A-CHESS smartphone intervention did not significantly improve overall abstinence from illicit opioid use compared to MOUD alone.

However, for participants without withdrawal symptoms and those on methadone, the combination of MOUD+A-CHESS showed higher abstinence rates and greater meeting attendance, suggesting potential benefits for specific groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial. Gustafson, DH., Landucci, G., Vjorn, OJ., et al.[2023]

A survey of 202 individuals using the A-CHESS app revealed that features like messaging and motivational resources were most effective in helping users manage feelings of anxiety, loneliness, and isolation during the COVID-19 pandemic.

Barriers to using the app included a lack of knowledge on how to use it and the absence of personalized treatment plans, suggesting that improving user education and app customization could enhance long-term engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Preferences for Mobile Health Applications to Support Recovery. Fleddermann, K., Molfenter, T., Vjorn, O., et al.[2023]

A survey of 71 opiate-dependent adults in a buprenorphine treatment program revealed that nearly all participants owned mobile phones and were comfortable using text messaging, indicating a strong potential for mobile technology in addiction treatment.

Most participants preferred having direct access to their providers via mobile phone and expressed interest in using text messaging to alert their clinic about potential relapses, suggesting that mobile interventions could enhance patient engagement and support in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone use patterns and preferences in safety net office-based buprenorphine patients. Tofighi, B., Grossman, E., Buirkle, E., et al.[2018]

Mobile phone applications, when used alongside standard addiction treatments, can enhance the effectiveness of these treatments by providing tools for information, monitoring, motivation, and relapse prevention.

Most studies reviewed indicated that patients using these applications experienced a greater reduction in substance consumption compared to those receiving standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. Penzenstadler, L., Thorens, G., Bachmann, S.[2022]

The qualitative study involving 20 users of the SURE Recovery app revealed that first impressions, such as trust and personal recommendations, significantly influence the app's uptake among individuals seeking support for substance use issues.

User engagement with the app improved when it provided positive feelings and relevant content, highlighting the importance of incorporating end-user feedback into app design to enhance its effectiveness in addiction recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons for Uptake and Engagement of a Smartphone App (SURE Recovery) for People in Recovery From Alcohol and Other Drug Problems: Interview Study of App Users. Neale, J., Bowen, AM.[2022]

A study of 87 addiction recovery smartphone apps revealed that they primarily offer information on recovery, motivation enhancement, social support, and progress monitoring tools, which users found helpful for staying focused and connected.

Despite the positive user experiences, most of these apps lack formal evaluations, indicating a need for further research to determine their effectiveness as standalone or supplementary interventions in addiction recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the focus and experiences of smartphone applications for addiction recovery. Savic, M., Best, D., Rodda, S., et al.[2022]

In a pilot study involving 30 participants from a Massachusetts drug court program, the A-CHESS mobile app was used regularly, with participants opening the app on average 62% of the days over four months, indicating strong engagement with the recovery support tool.

The most popular feature of the app was its social networking tools, suggesting that peer support may play a crucial role in helping addicted offenders manage their recovery effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Test of a Mobile App for Drug Court Participants. Johnson, K., Richards, S., Chih, MY., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05033028

NCT05033028 | Smartphones for Opiate Addiction Recovery Treatments for opioid addiction exist, but effectiveness is compromised when subjects use illicit opiates during treatment. Reuse rates during treatment can ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827185

Smartphone App–Based Contingency Management and ... This cohort study compares treatment outcomes associated with augmented medication for opioid use disorder with smartphone app–based ...

3. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-025-00549-y

What smartphone apps exist to support recovery from opioid ... An estimated 84181 people died due to opioid overdose in 2022 alone [1]. Mobile technologies may offer an additional pathway to provide ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612830/

Smartphone App–Based Contingency Management and ... What is the association between using smartphone app–based contingency management with medication for opioid use disorder (MOUD) and ...

5. medicalxpress.com medicalxpress.com/news/2024-12-smartphone-app-opioid-patients-treatment.html

Smartphone app can help reduce opioid use and keep ... Patients with opioid use disorder can reduce their days of opioid use and stay in treatment longer when using a smartphone app as supportive therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7305558/

Technologies for Opioid Use Disorder Management The overarching aim of our research was to design OUD management technologies that utilize wearable sensors to provide continuous monitoring capabilities.

7. formative.jmir.org formative.jmir.org/2022/7/e38684

Literature Review and Cross-sectional Survey Study Across ... Smartphone Ownership, Smartphone Utilization, and Interest in Using Mental Health Apps to Address Substance Use Disorders: Literature Review and ...

8. washington.edu washington.edu/news/2019/01/09/smartphone-app-detects-opioid-overdose/

First smartphone app to detect opioid overdose and its ... Researchers have developed a cellphone app that uses sonar to monitor someone's breathing rate and sense when an opioid overdose has occurred.