Smartphone App for Opioid Use Disorder

Overseen By Noah R Wolkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Buprenorphine, Methadone

Disqualifiers: Untreated psychiatric disorders, Suicidal ideation, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app, ACT to RECOVER, designed to improve the lives of Veterans with Opioid Use Disorder (OUD) who are already receiving medication like buprenorphine or methadone. The app employs Acceptance and Commitment Therapy (ACT) to help individuals live more value-driven and fulfilling lives, offering a more convenient format than traditional therapy sessions. The goal is to determine if this app can facilitate condition management and enhance quality of life for Veterans. Veterans who have been on medication for OUD for less than a year and own a smartphone might be suitable for this study. As an unphased trial, this study provides Veterans with a unique opportunity to contribute to innovative research that could enhance treatment options for OUD.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, participants must be actively receiving medication treatment for opioid use disorder, such as buprenorphine or methadone, to be eligible.

What prior data suggests that this smartphone app is safe for Veterans with opioid use disorder?

Research shows that smartphone apps for opioid addiction can be helpful without major safety concerns. Studies on similar apps have found that users often feel less anxious and are less likely to use opioids. These apps provide support and information precisely when users need it, which can be very beneficial.

While the ACT to RECOVER app is still being tested, other digital tools for opioid addiction have not shown significant safety issues. This suggests that the ACT to RECOVER app might also be safe. However, as a new app, it requires further research to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT to RECOVER smartphone app for opioid use disorder because it offers a unique approach compared to traditional treatments like medication-assisted therapy (MAT) with methadone or buprenorphine. Unlike these standard options, which primarily focus on managing withdrawal symptoms and cravings through medication, ACT to RECOVER uses a digital platform to deliver Acceptance and Commitment Therapy (ACT). This therapy encourages users to embrace their thoughts and feelings rather than fighting them, potentially empowering individuals to better manage their cravings and triggers. Additionally, the app's accessibility allows for support and intervention anytime, which is a game-changer for maintaining progress in real-world settings.

What evidence suggests that this smartphone app is effective for opioid use disorder?

Research has shown that smartphone apps can aid in recovery from opioid use disorder (OUD). One study found that apps used alongside medication treatment improved recovery outcomes. Another app, A-CHESS, helped users abstain from opioids. These findings suggest that apps can complement traditional treatments like methadone or buprenorphine. In this trial, participants in the treatment arm will use the ACT to RECOVER app, designed to enhance these successes by providing an easy-to-use tool specifically to improve the lives of Veterans receiving medication treatment for OUD. Meanwhile, participants in the control arm will use a smartphone-based symptom-monitoring program. ^{6 7 8 9 10}

Who Is on the Research Team?

Noah R Wolkowicz, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for Veterans with Opioid Use Disorder (OUD) who are currently receiving medication treatment. It aims to improve their quality of life and psychosocial functioning through a new smartphone app, 'ACT to RECOVER'.

Inclusion Criteria

Current diagnosis of Opioid Use Disorder (OUD) indicated by either DSM-5-TR or ICD-9 or -10 codes

I am currently on medication for opioid use disorder.

I understand and can sign the consent form.

Exclusion Criteria

Have been on MOUD, in their current treatment episode (i.e., since their most recent induction), for longer than 12 consecutive months prior to their baseline visit

Have any cognitive/medical impairment precluding study participation or use of smartphones/smartphone applications

Have untreated major psychiatric disorders (e.g., bipolar disorders, psychotic disorders)

Timeline for a Trial Participant

Development

Develop content for ACT to RECOVER using Veteran and provider feedback

15 months

Iterative Usability Assessment

Conduct field testing to refine ACT to RECOVER format, acceptability, and usability

18 months

Pilot RCT

Conduct a pilot trial to compare ACT to RECOVER to a smartphone-based symptom monitoring control group

27 months

Baseline, midpoint, endpoint, and follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACT to RECOVER
• Smartphone-based Symptom-Monitoring

Trial Overview The study tests 'ACT to RECOVER', an app based on Acceptance and Commitment Therapy, against standard symptom-monitoring via smartphone. The trial includes developing the app with Veteran feedback, refining it through usability testing, and then comparing outcomes in a pilot randomized controlled trial.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will receive the prototype ACT to RECOVER smartphone intervention for 4 weeks.

Group II: Control Placebo Group 1 Intervention

This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will be assigned to receive a smartphone-based symptom-monitoring program for 4 weeks.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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 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]

The use of reSET-O, a digital therapeutic for patients undergoing buprenorphine medication-assisted treatment for opioid use disorder, led to a significant reduction in healthcare encounters, including 45 fewer inpatient visits and 27 fewer emergency department visits over six months among 351 patients.

Patients also experienced a net cost savings of $2,150 per person, indicating that reSET-O not only improved treatment adherence but also reduced overall healthcare costs associated with opioid use disorder management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Velez, FF., Colman, S., Kauffman, L., et al.[2022]

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

A significant increase in Opioid Use Disorder (OUD) diagnoses during pregnancy highlights the need for effective treatment solutions, which this study addresses through feedback from 18 peripartum individuals and 19 obstetric providers.

The development of the Listening to Women and Pregnant and Postpartum People (LTWP) program, informed by qualitative interviews, aims to enhance the implementation of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) in prenatal care, although initial feedback indicated a lack of enthusiasm for the web-based intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. Guille, C., Hall, C., King, C., et al.[2023]

Methadone is the most effective medication for treating opioid use disorder (OUD), as it helps suppress withdrawal symptoms and has strong evidence supporting its efficacy, especially with longer treatment durations leading to better social outcomes.

New formulations of buprenorphine and naltrexone, along with take-home naloxone programs, aim to improve safety and adherence in OUD treatment, addressing issues like relapse and overdose risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Treatment of Opioid Use Disorder. Bell, J., Strang, J.[2021]

A study is being conducted to evaluate the effectiveness of the smartphone app OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), particularly among adults in outpatient settings.

The trial will compare opioid misuse rates between participants using OptiMAT alongside their treatment and those receiving standard treatment alone, with results expected to inform future use of the app in rural areas and identify which features of OptiMAT are most beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, M., 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06454903

Developing a Smartphone Application to Support Veteran ... ACT to RECOVER will be a smartphone app designed to act as a flexible, semi-structured, user-friendly adjunct to standard medication treatment for opioid use ...

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

Smartphone App–Based Contingency Management and ... These findings suggest that adding app-based contingency management to MOUD is associated with better treatment outcomes in clinical settings.

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

What smartphone apps exist to support recovery from opioid ... The app “ProCare Recovery” provides an automated contingency management approach for managing OUD [16]. To test the acceptability and usability ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7861202/

Outcomes for patients receiving telemedicine-delivered ... We examined several demographic and substance use variables for individuals who consented to telemedicine treatment, retention in treatment over time, and ...

5. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230976

Can Smartphone-Based Support Apps Add Value to the ... This large randomized controlled trial evaluated the acceptability and effectiveness (opioid abstinence) of a smartphone-based patient support app (A-CHESS)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10265406/

An Artificial Intelligence–Based Smartphone App for ... The major objective of our pilot study was to develop a smartphone app that can track work-related risk factors leading to OUD with a specific focus on high- ...

7. withpower.com withpower.com/trial/phase-opioid-related-disorders-1-2025-a2680

Smartphone App for Opioid Use Disorder ACT to RECOVER is unique because it uses a smartphone app to support people with opioid use disorder, providing just-in-time interventions and information to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528045/

Digitally-enhanced medication-assisted treatment for opioid ... The Recovery Connect app is a CMS branded version of Recovery Path, a digital tool designed to enhance and complement the delivery of MOUD. It ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/1533256X.2025.2471330?af=R

Psychosocial outcomes associated with mobile health app ... Logging into the app but not using the e-coach feature was associated with reduced anxiety and decreased likelihood of opioid use, while use of the app's e- ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807340

Provision of Digital Health Technologies for Opioid Use ... This cross-sectional study uses national survey data to examine patient-facing digital health technology use for opioid use disorder ...